Phase III clinical trial of ABCB5+ MSCs for the treatment of EB

2022-500266-10-00 Protocol allo-APZ2-EB-III Therapeutic confirmatory (Phase III) Authorised, recruiting

Start 13 Jun 2023 · Status Authorised, recruiting · 12 EU/EEA countries · 18 sites · Protocol allo-APZ2-EB-III

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruiting
Participants planned 167
Countries 12
Sites 18

Recessive Dystrophic Epidermolysis Bullosa(RDEB) and Junctional Epidermolysis Bullosa (JEB)

The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo. An additional baseline-controlled open-label arm will be included to investigate the safety and efficacy of allo-AP…

Key facts

Sponsor
Rheacell GmbH & Co. KG
Participant type
Pediatric, Patients
Age range
0-17 years, 18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trial duration
13 Jun 2023 → ongoing
Decision date (initial)
2022-12-12
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
RHEACELL GmbH & Co. KG

External identifiers

EU CT number
2022-500266-10-00
ClinicalTrials.gov
NCT05464381

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo. An additional baseline-controlled open-label arm will be included to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with JEB and to RDEB subjects < 1 year.

Conditions and MedDRA coding

Recessive Dystrophic Epidermolysis Bullosa(RDEB) and Junctional Epidermolysis Bullosa (JEB)

VersionLevelCodeTermSystem organ class
20.0 PT 10014989 Epidermolysis bullosa 100000004850

Regulatory references

Scientific advice from competent authorities
European Medicines Agency, Austrian Federal Office For Safety In Health Care
EMA paediatric investigation plan (PIP)
EMEA-002875-PIP01-20
Plan to share IPD
Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. 1. Male or female subjects from birth with a diagnosis of RDEB or JEB confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping (IFM). A minimal body weight of at least 5 kg is required;
  2. 2. Subject is eligible to participate in this clinical trial based on general health condition assessed by the following specific lab values: a. Hematology: Absolute neutrophil count > 1000/mm3 and platelet count > 150,000/mcL; b. Hepatic: AST and ALT < 2x the upper limit of normal for age; c. Renal: Creatinine < 2x the upper limit of normal for age; d. Pulmonary: Oxygen saturation > 92% on room air and without supplemental oxygen requirement;
  3. 3. Subject with a target wound meeting the following criteria: 5-50 cm2, and < 9 months, no signs of acute infection;
  4. 4. Patient/legal representative understands the nature of the procedure and provide written informed consent/assent prior to any clinical trial procedure;
  5. 5. Women of childbearing potential must have a negative urine pregnancy test at Visit 1. Women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial.

Exclusion criteria 13

  1. 1. Signs and/or a history of skin precancerous and cancerous lesions at screening or any current tumor diseases, including squamous cell carcinoma and basal cell carcinoma;
  2. 2. Known chronic lung disease;
  3. 3. Clinically significant laboratory values for coagulation and thrombocytes at screening;
  4. 4. Thromboembolic events of any grade in medical history;
  5. 5. Immunoreactions of any grade in medical history;
  6. 6. Any known allergies to components of the IP* or premedication;
  7. 7. Patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol;
  8. 8. Pregnant or lactating women;
  9. 9. Current or previous (within 30 days of screening) treatment with another IP, or participation and/or under follow-up in another interventional clinical trial;
  10. 10. Previous participation in this clinical trial** (except for screening failures);
  11. 11. Clinically significant or unstable concurrent disease or other clinical contraindications like an uncontrolled or poorly controlled mental health condition of the subject and/or his/her legal representative that could impact on patient’s safety or interfere with study compliance such as inability to attend scheduled study visits;
  12. 12. Employees of the sponsor, or employees or relatives of the investigator.
  13. *IP: Ringer lactate, glucose, DMSO ** Except for subjects enrolled under protocols issued before 2024. Re-screening may only be performed after a thorough benefit/risk assessment performed by the investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. • Proportion of subjects with RDEB ≥ 1 year with complete target wound closure at Month 6 (complete closure at Month 6a and confirmed 2 weeks later at Month 6b).

Secondary endpoints 22

  1. Secondary efficacy endpoints for each of the study populations RDEB ≥ 1 year, RDEB < 1 year, and JEB separately
  2. • Proportion of subjects with complete target wound closure at each post-baseline visit (complete closure at the respective post-baseline visit and confirmed at the next visit at least 2 weeks apart);
  3. • Change in overall wound burden (percent change in number of all recurrent and chronic Day 0 wounds per patient) at each post-baseline visit;
  4. • Duration of target wound closure;
  5. • Time to complete target wound closure from baseline;
  6. • Change in pain severity assessed by FPS-R for subjects ≥ 4 years at each post-baseline visit;
  7. • Change in pain severity assessed by FLACC scale for subjects < 4 years at each post-baseline visit;
  8. • Change in itch severity assessed by ItchyQuant for subjects ≥ 4 years at each post-baseline visit;
  9. • Change in overall disease activity assessed by the EBDASI activity score at each post-baseline visit;
  10. • Change in overall disease damage assessed by the EBDASI damage score at each post-baseline visit;
  11. • Change in quality of life assessed by the CDLQI for subjects ≥ 4 years at each post-baseline visit;
  12. • Change in serum levels of inflammation markers at each post-baseline visit;
  13. • Development of new wounds;
  14. • Duration of closure of non-target wounds in overall wound burden per patient;
  15. • Optional: change in C7 expression, presence of ABCB5+ MSCs, and presence of immune cells on skin biopsies (for RDEB subjects only).
  16. Changes indicate changes from baseline. Secondary efficacy endpoints will be assessed at each post-baseline visit until Month 17. Data obtained until Month 6b will be used for the main analysis. In addition, changes will be determined compared to Month 6b.
  17. Safety endpoints for each of the study populations RDEB ≥ 1 year, RDEB < 1 year, and JEB separately • Anti-Human Leukocyte Antigen (Anti-HLA) antibody levels will be analyzed for assessment of immunogenicity at Month 6a, Month 12, and in case an immune reaction occurs;
  18. • Potential immune reactions will be assessed by T-cell analysis;
  19. • Frequency of adverse events and serious adverse events;
  20. • Frequency of adverse events of special interest;
  21. • Physical examination, laboratory parameters and vital signs;
  22. • Overall survival.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

allo-APZ2-OTS

PRD9606976 · Product

Active substance
Allogeneic Skin-Derived ABCB5-POSITIVE Dermal Mesenchymal Stromal Cells
Pharmaceutical form
CELL SUSPENSION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
2000000 DF dosage form
Max total dose
16000000 DF dosage form
Max treatment duration
11 Month(s)
Authorisation status
Not Authorised
MA holder
RHEACELL GMBH & CO. KG
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/19/2160

Placebo 1

Placebo-OTS (cryomedium RGD10)

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Auxiliary 20

Fexofenadine Hydrochloride 120 mg Film-coated tablets

PRD8170004 · Product

Active substance
Fexofenadine Hydrochloride
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
120 mg milligram(s)
Max total dose
120 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AX26 — FEXOFENADINE
Marketing authorisation
PA22871/004/002
MA holder
AZURE PHARMACEUTICALS LTD
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pipolphen 25 mg/ml oldatos injekció

PRD2047445 · Product

Active substance
Promethazine Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
100 mg milligram(s)
Max total dose
100 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AD02 — PROMETHAZINE
Marketing authorisation
OGYI-T-3086/01
MA holder
EGIS PHARMACEUTICALS PLC
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methylprednisolone 1000 mg powder and solvent for solution for injection/infusion

PRD372936 · Product

Active substance
Methylprednisolone
Substance synonyms
6-METHYLPREDNISOLONE
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAMUSCULAR USE
Max daily dose
1 g gram(s)
Max total dose
1 g gram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
H02AB04 — METHYLPREDNISOLONE
Marketing authorisation
PL 18157/0228
MA holder
BEACON PHARMACEUTICALS LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Neoclarityn 0.5 mg/ml oral solution

PRD8926282 · Product

Active substance
Desloratadine
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL USE
Max daily dose
45 mg milligram(s)
Max total dose
45 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AX27 — DESLORATADINE
Marketing authorisation
EU/1/00/161/059
MA holder
N.V. ORGANON
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dibondrin - Ampullen

PRD1959904 · Product

Active substance
Diphenhydramine Hydrochloride
Substance synonyms
DIPHENHYDRAMINE HCL
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
400 mg milligram(s)
Max total dose
400 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
N05CM, R06AA02 — OTHER HYPNOTICS AND SEDATIVES, DIPHENHYDRAMINE
Marketing authorisation
7162
MA holder
PHARMAZEUTISCHE FABRIK MONTAVIT GES.M.B.H
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cetirizine dihydrochloride 10 mg film-coated tablets

PRD2748226 · Product

Active substance
Cetirizine Dihydrochloride
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AE07 — CETIRIZINE
Marketing authorisation
PL 20416/0278
MA holder
CRESCENT PHARMA LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Solu-Decortin® H 10 mg

PRD374241 · Product

Active substance
Prednisolone Sodium Succinate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1000 mg milligram(s)
Max total dose
1000 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
H02AB06 — PREDNISOLONE
Marketing authorisation
9238.00.00
MA holder
MERCK HEALTHCARE GERMANY GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tavegil Injektionslösung 2 mg / 2 ml Wirkstoff: Clemastinfumarat

PRD6749564 · Product

Active substance
Clemastine Fumarate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
2 ml millilitre(s)
Max total dose
2 ml millilitre(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AA04 — CLEMASTINE
Marketing authorisation
6521302.00.00
MA holder
GEBRO PHARMA GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rupafin 10 mg Tablets

PRD330326 · Product

Active substance
Rupatadine
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AX28 — RUPATADINE
Marketing authorisation
PA1129/001/1
MA holder
NOUCOR HEALTH, S.A.
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lorastad 10 mg, tabletten

PRD394740 · Product

Active substance
Loratadine
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AX13 — LORATADINE
Marketing authorisation
RVG 24785
MA holder
STADA ARZNEIMITTEL AG
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Trimeton 10 mg/1 ml soluzione iniettabile

PRD2984511 · Product

Active substance
Chlorphenamine Maleate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
40 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AB04 — CHLORPHENAMINE
Marketing authorisation
006152021
MA holder
BAYER SPA
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xyzal 0.5 mg/ml oral solution

PRD435720 · Product

Active substance
Levocetirizine Dihydrochloride
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL USE
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AE09 — LEVOCETIRIZINE
Marketing authorisation
PA 891/3/3
MA holder
UCB PHARMA IRELAND LTD (DUBLIN IE)
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Neoclarityn 5 mg film-coated tablets

PRD8926174 · Product

Active substance
Desloratadine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AX27 — DESLORATADINE
Marketing authorisation
EU/1/00/161/011
MA holder
N.V. ORGANON
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

POLARAMINE 5 mg/1 ml, solution injectable

PRD7705407 · Product

Active substance
Dexchlorpheniramine Maleate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AB02 — DEXCHLORPHENIRAMINE
Marketing authorisation
34009 308 492 5 5
MA holder
LABORATORIOS FARMACÉUTICOS ROVI, S.A
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Synopen 20 mg/2 ml otopina za injekciju

PRD5960152 · Product

Active substance
Chloropyramine Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
0.2 mg/kg milligram(s)/kilogram
Max total dose
0.2 mg/Kg milligram(s)/kilogram
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AC03 — CHLOROPYRAMINE
Marketing authorisation
HR-H-068837229
MA holder
PLIVA HRVATSKA D.O.O.
MA country
Croatia
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xyzal 5 mg film-coated tablets

PRD439495 · Product

Active substance
Levocetirizine Dihydrochloride
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AE09 — LEVOCETIRIZINE
Marketing authorisation
PA 891/3/1
MA holder
UCB PHARMA IRELAND LTD (DUBLIN IE)
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rupatadine 1 mg/ml oral solution

PRD9567664 · Product

Active substance
Rupatadine
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL USE
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AX28 — RUPATADINE
Marketing authorisation
PL35533/0186
MA holder
ASPIRE PHARMA LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zirtek 1 mg/ml oral solution

PRD439896 · Product

Active substance
Cetirizine Dihydrochloride
Substance synonyms
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HCL
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL USE
Max daily dose
20 mg milligram(s)
Max total dose
20 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AE07 — CETIRIZINE
Marketing authorisation
PA0891/008/003
MA holder
UCB PHARMA IRELAND LTD (DUBLIN IE)
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Efcortesol Injection

PRD2781738 · Product

Active substance
Hydrocortisone Sodium Phosphate
Substance synonyms
HYDROCORTISONE 21-PHOSPHATE DISODIUM
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
200 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
H02AB09 — HYDROCORTISONE
Marketing authorisation
PL 20072/0229
MA holder
AMDIPHARM UK LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Loratadine 5 mg/5 ml Syrup

PRD991970 · Product

Active substance
Loratadine
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL USE
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
R06AX13 — LORATADINE
Marketing authorisation
PL 04917/0067
MA holder
PINEWOOD LABORATORIES LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rheacell GmbH & Co. KG

3 Total trials 1 Recruiting 2 Ended
Commercial
Sponsor organisation
Rheacell GmbH & Co. KG
Address
Im Neuenheimer Feld 517, Neuenheim Neuenheim
City
Heidelberg
Postcode
69120
Country
Germany

Scientific contact point

Organisation
Rheacell GmbH & Co. KG
Contact name
office Rheacell (clinical operation department)

Public contact point

Organisation
Rheacell GmbH & Co. KG
Contact name
office Rheacell (clinical operation department)

Third parties 9

OrganisationCity, countryDuties
Invisio Clinical Studies Consulting GmbH
ORG-100048020
 Mannheim, Germany Other
Syneos Health Hellas Single Member S.A.
ORG-100043210
 Vrilissia, Greece On site monitoring, Code 11, Code 12, Code 2, Data management, Code 8
Canfield Scientific Inc.
ORG-100042834
 Parsippany, United States Other
Ticeba GmbH
ORG-100020929
 Heidelberg, Germany Code 14, Other
Histalim
ORG-100042721
 Montpellier, France Other
PPD International Holdings LLC
ORG-100007655
 Zaventem, Belgium Other, Laboratory analysis
Syneos Health Netherlands B.V.
ORG-100013861
 Amsterdam, Netherlands On site monitoring, Code 11, Code 12, Code 2, Data management, Code 8
Colpitts Clinical
ORG-100043100
 Norwood, United States Other
Bender Medsystems GmbH
ORG-100042278
 Vienna, Austria Laboratory analysis

Locations

12 EU/EEA countries · 18 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ended 5 1
Croatia Ended 7 1
Denmark Ended 7 1
France Ongoing, recruitment ended 12 3
Germany Not authorised 15 2
Greece Ongoing, recruitment ended 5 2
Hungary Ongoing, recruitment ended 8 1
Italy Ongoing, recruitment ended 20 3
Netherlands Ended 7 1
Poland Ongoing, recruitment ended 8 1
Portugal Ongoing, recruitment ended 10 1
Spain Ongoing, recruitment ended 15 1
Rest of world
Argentina, Chile, Israel, Taiwan, United Kingdom
 — 48 —

Investigational sites

Austria

1 site · Ended
Eb-Haus Austria Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
EB-Haus Austria, Universitätsklinik für Dermatologie und Allergologie, Muellner Hauptstrasse 48, 5020, Salzburg

Croatia

1 site · Ended
University Hospital Centre Zagreb
dermatovenerology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb

Denmark

1 site · Ended
Rigshospitalet
Center for rare diseases, Blegdamsvej 9, 2100, Copenhagen Oe

France

3 sites · Ongoing, recruitment ended
Centre Hospitalier Universitaire De Nice
Service de Dermatologie, 151 Route De Saint Antoine, 06200, Nice
Assistance Publique Hopitaux De Paris
Service de Dermatologie, 149 Rue De Sevres, 75015, Paris
Hopital Saint Louis
Service de Dermatologie, 1 Avenue Claude Vellefaux, 75010, Paris

Germany

2 sites · Not authorised
Hannoversche Kinderheilanstalt
Dermatology, Janusz-Korczak-Allee 12, Bult, Hanover
Medical Center - University Of Freiburg
Dermatology, Hauptstraße 7, Herdern, Freiburg Im Breisgau

Greece

2 sites · Ongoing, recruitment ended
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
1ST UNIVERSITY CLINIC OF VENEREAL AND SKIN DISEASES, Dragoumi Ionos 5 I, 161 21, Athens
Ippokratio General Hospital Of Thessaloniki
First Department of Dermatology, Faculty of Medicine of A.U.Th, Delfon 124, 546 43, Thessaloniki

Hungary

1 site · Ongoing, recruitment ended
Semmelweis University
Bőr-, Nemikórtani és Bőronkológiai Klinika, Maria Utca 41, 1085, Budapest VIII

Italy

3 sites · Ongoing, recruitment ended
University Hospital Consorziale Policlinico
UO Dermatologia e Venereologia Universitaria, Piazzale Giulio Cesare 11, 70124, Bari
Bambino Gesu Children’s Hospital
U.O.C. di Dermatologia, Piazza Sant'onofrio 4, 00165, Rome
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
U.O.C. Pediatria 1, Via Della Commenda 12, 20122, Milan

Netherlands

1 site · Ended
University Medical Center Groningen
Department of Dermatology, P. O. Box 30001, 9700 RB, Groningen

Poland

1 site · Ongoing, recruitment ended
Med Sp. z o.o.
N/A, Ul. Polnej Rozy 6/u2, 02-798, Warsaw

Portugal

1 site · Ongoing, recruitment ended
Centro Hospitalar E Universitario De Coimbra E.P.E.
Dermatology, Avenida Afonso Romao, 3000-602, Coimbra

Spain

1 site · Ongoing, recruitment ended
Hospital Universitario La Paz
Pediatric Dermatology, Paseo Castellana 261, 28046, Madrid

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2023-06-13 2023-06-13 2023-11-29
Croatia
Denmark
France 2024-10-02 2024-10-02 2025-02-07
Greece 2024-09-11 2024-09-11 2025-02-07
Hungary 2023-11-06 2023-11-06 2025-02-07
Italy 2023-11-27 2023-11-27 2025-02-07
Netherlands
Poland 2023-10-10 2023-10-10 2025-02-07
Portugal 2024-12-11 2024-12-11 2025-02-07
Spain 2025-01-23 2025-01-23 2025-02-07

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 4 · Art. 38 CTR

Temporary halt TH-9283

Halt date
2023-11-29
Member states concerned
Austria
Publication date
2023-12-07
Reason
Safety related (clinical or pre-clinical results)
Follow-up measures
Please refer to “reason for change of subject safety and /or benefit-risk balance. And to the attached document&#34;
Benefit-risk balance changed
Yes
Treatment stopped
Yes

Temporary halt TH-9281

Halt date
2023-11-29
Member states concerned
Hungary
Publication date
2023-12-07
Reason
Safety related (clinical or pre-clinical results)
Follow-up measures
Please refer to “reason for change of subject safety and /or benefit-risk balance. And to the attached document&#34;
Benefit-risk balance changed
Yes
Treatment stopped
Yes

Temporary halt TH-9279

Halt date
2023-11-29
Member states concerned
Italy
Publication date
2023-12-07
Reason
Safety related (clinical or pre-clinical results)
Follow-up measures
Please refer to “reason for change of subject safety and /or benefit-risk balance. And to the attached document&#34;
Benefit-risk balance changed
Yes
Treatment stopped
Yes

Temporary halt TH-9277

Halt date
2023-11-29
Member states concerned
Poland
Publication date
2023-12-07
Reason
Safety related (clinical or pre-clinical results)
Follow-up measures
Please refer to “reason for change of subject safety and /or benefit-risk balance. And to the attached document&#34;
Benefit-risk balance changed
Yes
Treatment stopped
Yes

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 436 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) allo-APZ2-EB-III Protocol GRE for publication_TC 3.0
Protocol (for publication) allo-APZ2-EB-III_CORE GLP statement_for publication NA
Protocol (for publication) Allo-APZ2-EB-III_CRF Unique Pages_for publication 2.4
Protocol (for publication) allo-APZ2-EB-III_FLACC Scale_for publication 1.0
Protocol (for publication) allo-APZ2-EB-III_Protocol for publication TC 3.0
Protocol (for publication) allo-APZ2-EB-III_Questionnaires EBDAS_for publication 1.0
Protocol (for publication) Canfield statement_IFL_DoCs_for publication NA
Protocol (for publication) D1__allo-APZ2-EB-III Protocol GRE_Redacted 4.0
Protocol (for publication) D1__Protocol ENG_2022-500266-10-00_redacted 4.0
Protocol (for publication) D1_Protocol GRE_2022-500266-10-00_Redacted 7.0
Protocol (for publication) D1_Protocol_2022-500266-10-00_Redacted 7.0
Protocol (for publication) D1_Protocol_2022-500266-10-00_SoC 1.0
Protocol (for publication) D4__Patient facing documents_CDLQI_Cartoon_hr_HRV 1.0
Protocol (for publication) D4__Patient facing documents_CDLQI_hr_HRV 1.0
Protocol (for publication) D4__Patient facing documents_FPS-R_gl_GRE 1.0
Protocol (for publication) D4__Patient facing documents_FPS-R_hr_HRV 1.0
Protocol (for publication) D4__Patient facing documents_ItchQuant_hr_HRV 2.0
Protocol (for publication) D4_Patient facing documents_CDLQI_ PRT 1.0
Protocol (for publication) D4_Patient facing documents_CDLQI_cartoon_ESP 1.0
Protocol (for publication) D4_Patient facing documents_CDLQI_cartoon_PRT 1.0
Protocol (for publication) D4_Patient facing documents_CDLQI_ESP 1.0
Protocol (for publication) D4_Patient facing documents_FPS-R_ PRT 1.0
Protocol (for publication) D4_Patient facing documents_FPS-R_ESP 1.0
Protocol (for publication) D4_Patient facing documents_ItchQuant_ PRT 1.0
Protocol (for publication) D4_Patient facing documents_ItchQuant_ESP 1.0
Protocol (for publication) Patient facing document_CDLQI _EL_ GRE FP 1.0
Protocol (for publication) Patient facing document_CDLQI _ENG _FP 1.0
Protocol (for publication) Patient facing document_CDLQI cartoon EL_ GRE_ FP 0.1
Protocol (for publication) Patient facing document_CDLQI_cartoon_ENG_ FP 1.0
Protocol (for publication) Patient facing document_Facepainscale _ENG _FP 1.0
Protocol (for publication) Patient facing document_facepainscale_ EL_ GRE_ FP 2
Protocol (for publication) Patient facing document_ItchyQuant _ENG _FP 2.0
Protocol (for publication) Patient facing document_ItchyQuant EL_ GRE_ FP 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material advocacy_study_fact_sheet_Polish_Extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material flowchart_Polish_Extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material patient_brochure _Polish_Extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material poster_with_flyer_Polish_Extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material study_visit_guide_Polish_Extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_advocacy_PAG_enewsletter_article_DK_Extract 3.1
Recruitment arrangements - Extract (for publication) K2_Recruitment material_advocacy_PAG_enewsletter_article_Polish_Extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_advocacy_PAG_patient_FAQ_brochure_DK_Extract 2.1
Recruitment arrangements - Extract (for publication) K2_Recruitment material_advocacy_PAG_to_patient_letter_Polish_Extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_advocacy_study_fact_sheet_DK_Extract 2.1
Recruitment arrangements - Extract (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_PAG_enewsletter_article_HU_extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_PAG_patient_FAQ_brochure_HU_extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_PAG_to_patient_letter_HU_extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_site_to_PAG_intro_letter_HU_extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_study_fact_sheet_HU_extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_allo-APZ2-EB-III_flowchart_HU_extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_allo-APZ2-EB-III_patient_brochure_HU_extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_allo-APZ2-EB-III_poster_with_flyer_HU_extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_allo-APZ2-EB-III_study_visit_guide_HU_extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recruitment material_patient_brochure_DK_Extract 3.1
Recruitment arrangements - Extract (for publication) K2_Recruitment material_poster_with_flyer_DK_Extract 3.1
Recruitment arrangements - Extract (for publication) K2_Recruitment material_social_media_ads_DK_Extract 1.1
Recruitment arrangements - Extract (for publication) K2_Recruitment material_study_visit_guide_DK_Extract 2.1
Recruitment arrangements - Extract (for publication) K2_Recrutiment material_advocacy_PAG_patient_FAQ_brochure_Polish_Extract 2.0
Recruitment arrangements - Extract (for publication) K2_Recrutiment material_advocacy_site_to_PAG_intro_letter_Polish_Extract 2.0
Recruitment arrangements (for publication) allo-APZ2-EB-III_HUN_Recruitment arrangements_for publication 1.0
Recruitment arrangements (for publication) K1_ Recruitment arrangements_ESP 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_Recruitment and Informed consent procedure N/A
Recruitment arrangements (for publication) K1_Recruitment arrangement_DK_FP 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangement_GR 4.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_HR 4.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_NLD_FP 3.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_PRT 4.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_Recruitment and Informed consent procedure_TC N/A
Recruitment arrangements (for publication) K2_ Recruitment material dr to dr letter_ESP 1.0
Recruitment arrangements (for publication) K2_ Recruitment material flowchart_ESP 2.0
Recruitment arrangements (for publication) K2_ Recruitment material PAG enewsletter_ESP 3.0
Recruitment arrangements (for publication) K2_ Recruitment material PAG intro letter_ESP 2.0
Recruitment arrangements (for publication) K2_ Recruitment material PAG patient FAQ brochure_ESP 2.0
Recruitment arrangements (for publication) K2_ Recruitment material PAG to patient letter_ESP 2.0
Recruitment arrangements (for publication) K2_ Recruitment material patient brochure_ESP 3.0
Recruitment arrangements (for publication) K2_ Recruitment material poster with flyer_ESP 3.0
Recruitment arrangements (for publication) K2_ Recruitment material social media ads_ESP 1.0
Recruitment arrangements (for publication) K2_ Recruitment material study fact sheet_ESP 2.0
Recruitment arrangements (for publication) K2_ Recruitment material_advocacy_PAG_enewsletter_article EU_IT 3.0
Recruitment arrangements (for publication) K2_ Recruitment material_advocacy_PAG_patient_FAQ_brochure_EU_IT 2.0
Recruitment arrangements (for publication) K2_ Recruitment material_advocacy_PAG_to_patient_letter_EU_ IT 2.0
Recruitment arrangements (for publication) K2_ Recruitment material_advocacy_site_to_PAG_intro_letter_EU_ IT 2.0
Recruitment arrangements (for publication) K2_ Recruitment material_advocacy_study_fact_sheet_EU_IT 2.0
Recruitment arrangements (for publication) K2_ Recruitment material_flowchart_EU_IT 2.0
Recruitment arrangements (for publication) K2_ Recruitment material_patient_brochure_EU_IT 3.0
Recruitment arrangements (for publication) K2_ Recruitment material_poster_with_flyer_EU_IT 3.0
Recruitment arrangements (for publication) K2_ Recruitment material_study_visit_guide_EU_IT 2.0
Recruitment arrangements (for publication) K2_Additional document N/A
Recruitment arrangements (for publication) K2_Other subject information material_Dr to Dr Letter_PRT 1.0
Recruitment arrangements (for publication) K2_Other subject information material_Flowchart_PRT 2.0
Recruitment arrangements (for publication) K2_Other subject information material_PAG_FAQ brochure_PRT 2.0
Recruitment arrangements (for publication) K2_Other subject information material_PAG_Intro Letter_PRT 2.0
Recruitment arrangements (for publication) K2_Other subject information material_PAG_Study Fact Sheet_PRT 2.0
Recruitment arrangements (for publication) K2_Other subject information material_Patient Brochure_PRT 3.0
Recruitment arrangements (for publication) K2_Other subject information material_Poster wih flyer_PRT 3.0
Recruitment arrangements (for publication) K2_Other subject information material_Study Visit Guide_PRT 2.0
Recruitment arrangements (for publication) K2_Other subject information material_Visit Reminder Card_PRT 1.0
Recruitment arrangements (for publication) K2_Recruitment material advocacy_study_fact_sheet_Polish 2.0
Recruitment arrangements (for publication) K2_Recruitment material flowchart_Polish 2.0
Recruitment arrangements (for publication) K2_Recruitment material patient_brochure _Polish 3.0
Recruitment arrangements (for publication) K2_Recruitment material poster_with_flyer_Polish 3.0
Recruitment arrangements (for publication) K2_Recruitment material study_visit_guide_Polish 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_enewsletter_article_DK 3.1
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_enewsletter_article_DK_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Advocacy_PAG_enewsletter_article_NLD_FP 3.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_enewsletter_article_Polish 3.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_patient_FAQ_brochure_DK 2.1
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_patient_FAQ_brochure_DK_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_patient_FAQ_brochure_EU_GR 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_patient_FAQ_brochure_HR 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Advocacy_PAG_patient_FAQ_brochure_NLD_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_to_patient_letter_DK_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_to_patient_letter_EU_GR 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_to_patient_letter_HR 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Advocacy_PAG_to_patient_letter_NLD_Extract_FP 2.1
Recruitment arrangements (for publication) K2_Recruitment Material_Advocacy_PAG_to_patient_letter_NLD_FP 2.1
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_PAG_to_patient_letter_Polish 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_site to PAG intro letter_HR 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_site_to_PAG_intro_letter_DK_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_site_to_PAG_intro_letter_EU_GR 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Advocacy_site_to_PAG_intro_letter_NLD_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_study fact sheet_HR 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_study_fact_sheet_DK 2.1
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_study_fact_sheet_DK_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_advocacy_study_fact_sheet_EU_GR 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Advocacy_study_fact_sheet_NLD_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_PAG_enewsletter_article_HU 3.1
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_PAG_patient_FAQ_brochure_HU 2.2
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_PAG_to_patient_letter_HU 2.2
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_site_to_PAG_intro_letter_HU 2.2
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_advocacy_study_fact_sheet_HU 2.2
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_Dr_to_dr_letter 2.1
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_flowchart_HU 2.2
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_patient_brochure_HU 3.1
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_poster_with_flyer_HU 3.1
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_social_media_ads 2.1
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_study_visit_guide_HU 2.1
Recruitment arrangements (for publication) K2_Recruitment material_allo-APZ2-EB-III_visit_reminder_card 1.1
Recruitment arrangements (for publication) K2_Recruitment material_dr to dr letter_HR 1.0
Recruitment arrangements (for publication) K2_Recruitment material_dr_to_dr_letter_DK_FP 1.0
Recruitment arrangements (for publication) K2_Recruitment material_dr_to_dr_letter_EU_GR 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Dr_to_dr_letter_NLD_FP 1.0
Recruitment arrangements (for publication) K2_recruitment material_flowchart_AU 2.0
Recruitment arrangements (for publication) K2_Recruitment material_flowchart_DK_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_flowchart_EU_GR 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Flowchart_NLD_FP 2.0
Recruitment arrangements (for publication) K2_recruitment material_PAG_enewsletter_AU 3.0
Recruitment arrangements (for publication) K2_recruitment material_PAG_patient_FAQ_brochure_AU 2.0
Recruitment arrangements (for publication) K2_recruitment material_PAG_to_patient_letter_AU 2.0
Recruitment arrangements (for publication) K2_Recruitment material_patient brochure_HR 3.1
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing document_advocacy study fact sheet 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_advocacy PAG enewsletter article 3.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_advocacy PAG patient_FAQ_brochure 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_advocacy PAG to patient letter 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_advocacy site to_PAG intro letter 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_Dr to Dr letter 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_flowchart 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_patient brochure 3.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_patient card 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_poster with flyer 3.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_social media ads 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_study visit guide 2.1
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing documents_visit reminder card 1.0
Recruitment arrangements (for publication) K2_recruitment material_patient_brochure_AU 3.0
Recruitment arrangements (for publication) K2_Recruitment material_patient_brochure_DK 3.1
Recruitment arrangements (for publication) K2_Recruitment material_patient_brochure_DK_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_patient_brochure_EU_GR 3.0
Recruitment arrangements (for publication) K2_Recruitment Material_Patient_brochure_NLD_FP 3.0
Recruitment arrangements (for publication) K2_Recruitment material_poster with flyer_AU 3.0
Recruitment arrangements (for publication) K2_Recruitment material_poster with flyer_HR 3.0
Recruitment arrangements (for publication) K2_Recruitment material_poster_with_flyer_DK 3.1
Recruitment arrangements (for publication) K2_Recruitment material_poster_with_flyer_DK_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_poster_with_flyer_EU_GR 3.0
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_with_flyer_NLD_FP 3.0
Recruitment arrangements (for publication) K2_recruitment material_site_to_PAG_intro_letter_AU 2.0
Recruitment arrangements (for publication) K2_Recruitment material_social_media_ads_DK 1.1
Recruitment arrangements (for publication) K2_Recruitment material_social_media_ads_DK_FP 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Social_media_ads_NLD_FP 1.0
Recruitment arrangements (for publication) K2_Recruitment material_study flowchart_HR 2.0
Recruitment arrangements (for publication) K2_recruitment material_study_fact_sheet_AU 2.0
Recruitment arrangements (for publication) K2_Recruitment material_study_visit_guide_DK 2.1
Recruitment arrangements (for publication) K2_Recruitment material_study_visit_guide_DK_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Study_visit_guide_NLD_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_visit_reminder_card_DK_FP 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Visit_reminder_card_NLD_FP 1.0
Recruitment arrangements (for publication) K2_Recrutiment material_advocacy_PAG_patient_FAQ_brochure_Polish 2.0
Recruitment arrangements (for publication) K2_Recrutiment material_advocacy_site_to_PAG_intro_letter_Polish 2.0
Recruitment arrangements (for publication) Recruitment material _PAG_enewsletter_article_Polish 1.0
Recruitment arrangements (for publication) Recruitment material advocacy_PAG_patient_FAQ_brochure_Polish 1.0
Recruitment arrangements (for publication) Recruitment material advocacy_PAG_to_patient_letter_Polish 1.0
Recruitment arrangements (for publication) Recruitment material advocacy_site_to_PAG_intro_letter_Polish 1.0
Recruitment arrangements (for publication) Recruitment material advocacy_study_fact_sheet_Polish 1.0
Recruitment arrangements (for publication) Recruitment material dr_to_dr_letter_Polish 1.0
Recruitment arrangements (for publication) Recruitment material flowchart_Polish 1.0
Recruitment arrangements (for publication) Recruitment material patient_brochure_Polish 1.0
Recruitment arrangements (for publication) Recruitment material poster_with_flyer_Polish 1.0
Recruitment arrangements (for publication) Recruitment material social_media_ads_Polish 1.0
Recruitment arrangements (for publication) Recruitment material study_visit_guide_Polish 1.0
Recruitment arrangements (for publication) Recruitment material visit_reminder_card_Polish 1.0
Recruitment arrangements (for publication) Recruitment material_allo-APZ2-EB-III_HUN_Advocacy_PAG_enewsletter_article_EU 1.0
Recruitment arrangements (for publication) Recruitment material_allo-APZ2-EB-III_HUN_Advocacy_PAG_patient_FAQ_brochure_EU 1.0
Recruitment arrangements (for publication) Recruitment material_allo-APZ2-EB-III_HUN_Advocacy_PAG_to_patient_letter_EU 1.0
Recruitment arrangements (for publication) Recruitment material_allo-APZ2-EB-III_HUN_Advocacy_site_to_PAG_intro_letter_EU 1.0
Recruitment arrangements (for publication) Recruitment material_allo-APZ2-EB-III_HUN_Advocacy_study_fact_sheet_EU 1.0
Recruitment arrangements (for publication) Recruitment material_allo-APZ2-EB-III_HUN_Flowchart_EU 1.0
Recruitment arrangements (for publication) Recruitment material_allo-APZ2-EB-III_HUN_Patient_brochure_EU 1.0
Recruitment arrangements (for publication) Recruitment material_allo-APZ2-EB-III_HUN_Poster_with_flyer_EU 1.0
Recruitment arrangements (for publication) Recruitment material_allo-APZ2-EB-III_study_visit_guide_HUN 1.0
Recruitment arrangements (for publication) Recruitment material_dr to dr letter_for publication 1.1
Recruitment arrangements (for publication) Recruitment material_dr to dr letter_TC_for publication 1.1
Recruitment arrangements (for publication) Recruitment material_dr_to_dr_letter_EU 1.0
Recruitment arrangements (for publication) Recruitment material_social media ads_for publication 1.0
Recruitment arrangements (for publication) Recruitment material_social_media_ads_EU 1.0
Recruitment arrangements (for publication) Recruitment material_visit_reminder_card_EU 1.0
Recruitment arrangements (for publication) Template recruitment arrangements NA
Recruitment arrangements (for publication) Template recruitment arrangements 1.0
Recruitment arrangements (for publication) Template_Recruitment arrangements_for publication 2.0
Recruitment arrangements (for publication) Template_Recruitment arrangements_TC_for publication 2.0
Subject information and informed consent form - Extract (for publication) L1_Subject info and informed consent form_allo-APZ2-EB-III_Main ICF_HU_extract 3.1.0
Subject information and informed consent form (for publication) CDLQI_German_Austria_for publication N/A
Subject information and informed consent form (for publication) facepainscale_german_austria_for publication NA
Subject information and informed consent form (for publication) Global Visa Card Version German_Austria_for publication NA
Subject information and informed consent form (for publication) ItchQuant_Austria_for publication 1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF 6-11y 3.1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF pregnancy 1.1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF pregnant partner 1.2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_ Adolescent Assent_IT 4.2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_ Adult SIS - ICF_IT_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_ Child Assent 6-11y_IT 3.1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_ Parent SIS - ICF_IT_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_ Parent SIS - ICF_RO_redacted 4.2.0
Subject information and informed consent form (for publication) L1__SIS and ICF 13 to 17 yr_POL_redacted 3.1.0
Subject information and informed consent form (for publication) L1__SIS and ICF Main_POL_redacted 3.1.0
Subject information and informed consent form (for publication) L1__SIS and ICF Parent-Guardian_POL_redacted 3.1.1
Subject information and informed consent form (for publication) L1_SIS and ICF 15 to 17 yr_HR_redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF 4 to 7 yr_HR 2.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF 12 to 14 yr_HR_redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17y_ES 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF 13 to 17 yr_BY_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF 13 to 17 yr_PL_Redacted 4.4.0
Subject information and informed consent form (for publication) L1_SIS and ICF 13 to 17 yr_RU_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF 2 to 6 yr_POL 2.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF 7 to 12 yr_BY 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF 7 to 12 yr_POL 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF 7 to 12 yr_RU 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF 8 to 11 yr_HR 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF adult_ES 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF adults_HR_redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Colpitts Clinical_ HR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_BY_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_PL_Redacted 4.4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_RU_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Minor Pregnant Partner _HR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Minor Pregnant Subject_HR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Skin biopsy Parent_HR_redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Skin biopsy 12 to 14 yr_HR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Skin biopsy 15 to 17yr_HR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Skin biopsy adult_HR_redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Parent Guardian_HR_redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Parent of pregnant minor_ HR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Parent of Pregnant Participants Partner_HR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF parent_ES 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Parent-Guardian_BY_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Parent-Guardian_PL_Redacted 4.4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Parent-Guardian_RU_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Parent-Guardian_RUS 4.4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Partner _HR 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Subject_HR 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ Colpitts Clinical ICF_BY_Redacted 0.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ Colpitts Clinical ICF_RU_Redacted 0.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Assent 13-17_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Assent 4-6_Redacted 2.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Assent 7-12_Redacted 3.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Assent Form for Participants Aged 10 to 12 Years_GR 3.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Assent Form for Participants Aged 13 to 15 Years_GR 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Assent Form for Participants Aged 16 to 17 Years_GR 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Assent_15-17 years_DK_Extract_FP 3.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Assent_15-17 years_DK_FP 4.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Colpitts Clinical 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Colpitts Clinical ICF_BG_Redacted 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Colpitts Clinical ICF_GR_Redacted 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Colpitts Clinical_DK_FP 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Information Form for Participants Aged 2 to 5 Years_BG 2.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Information Form for Participants Aged 2 to 5 Years_GR 2.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Information Form for Participants Aged 6 to 9 Years_BG 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Information Form for Participants Aged 6 to 9 Years_GR 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Adult_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_GR_Redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Informed re-consent Form due to Adulthood_GR_Redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Minor turning 18 YO_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_DK_Extract_FP 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_DK_FP 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Biopsy_RO 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Parent Guardian of Minor Pregnant ICF_GR_Redacted 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Parent-Guardian ICF_BG_Redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Parent-Guardian ICF_GR_Redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Parent-Guardian_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Parents_DK_Extract_FP 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Parents_DK_FP 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy Assent Form_GR 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy ICF_GR_Redacted 1.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy informed re-consent form due to adulthood_GR_Redacted 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy_Redacted 1.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy-PP_Redacted 1.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner Assent Form_GR 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner ICF_GR_Redacted 1.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner Informed re-consent form due to Adulthood_GR_Redacted 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_DK_FP 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_Redacted 1.2.0
Subject information and informed consent form (for publication) L1_SIS ICF 10-17yr_AU_Redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS ICF 2-5yr_AU_Redacted 2.1.0
Subject information and informed consent form (for publication) L1_SIS ICF 6-9yr_AU_Redacted 3.2.0
Subject information and informed consent form (for publication) L1_SIS ICF Main_AU_Redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS ICF Parent-Guardian_AU_Redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS ICF_under 12 years_NLD_Extract_FP 3.2.0
Subject information and informed consent form (for publication) L1_SIS ICF_under 12 years_NLD_FP 3.2.0
Subject information and informed consent form (for publication) L1_SIS-ICF Child Assent Form 5-11yrs_PRT 3.3.0
Subject information and informed consent form (for publication) L1_SIS-ICF Child Assent Form Ages 12-15yrs_PRT_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS-ICF Main Ages over 16yrs_PRT_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS-ICF Parent_PRT_Redacted 4.3.0
Subject information and informed consent form (for publication) L1_SIS-ICF Pregnancy and Baby Follow-up_PRT 1.3.0
Subject information and informed consent form (for publication) L1_SIS-ICF Pregnant Partner and Baby Follow-up_PRT 1.3.0
Subject information and informed consent form (for publication) L1_SIS-ICF_12-16 Year_NLD_Extract_FP 3.2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_12-16 Year_NLD_FP 3.2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Main_NLD 4.2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Main_NLD_Extract_FP 3.2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Parents-Guardian_NLD 4.2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Parents-Guardian_NLD_Extract_FP 3.2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Pregnancy_NLD_Extract_FP 1.2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Pregnancy_NLD_FP 1.2.0
Subject information and informed consent form (for publication) L1_Subject info and informed consent form allo-APZ2-EB-III_Pregnancy ICF_HUN 2.1.0
Subject information and informed consent form (for publication) L1_Subject info and informed consent form allo-APZ2-EB-III_Pregnant Partner ICF_HUN 2.1.0
Subject information and informed consent form (for publication) L1_Subject info and informed consent form_allo-APZ2-EB-III_Main ICF_HU 4.2.0
Subject information and informed consent form (for publication) L2_ Other subject information materials _visit_reminder_card_EU_GR 1.0
Subject information and informed consent form (for publication) L2_Other subject Information material_ Reimbursem Proced_RO 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_CDLQI_cartoon_RU 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_CDLQI_V_BG 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_CDLQI_V_RU 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_FPS-R_V_RU 1.0
Subject information and informed consent form (for publication) L2_Other subject Information material_GP letter_RO_redacted 1.2.0
Subject information and informed consent form (for publication) L2_Other subject information material_ItchQuant_V_BG 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_ItchQuant_V_RU 2.0
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Card_PRT 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_Patient ID Card_HR_redacted 1.0
Subject information and informed consent form (for publication) L2_Other subject Information material_Reimbursem Req_redact 1.0
Subject information and informed consent form (for publication) L2_Other subject information materials_Global Visa Card 1.0
Subject information and informed consent form (for publication) L2_Other subject information materials_Global Visa Card_BG 1.0
Subject information and informed consent form (for publication) L2_Other subject information materials_Global Visa Card_GR 1.0
Subject information and informed consent form (for publication) L2_Other subject information materials_study visit guide_HR 2.0
Subject information and informed consent form (for publication) L2_Other subject information materials_study_visit_guide_EU_GR 2.0
Subject information and informed consent form (for publication) L2_Other subject information materials_Subject ID Card_BG_Redacted 1.0
Subject information and informed consent form (for publication) L2_Other subject information materials_Subject ID Card_GR_Redacted 1.0
Subject information and informed consent form (for publication) L2_Other subject information materials_visit reminder card_HR 1.0
Subject information and informed consent form (for publication) L2_Other subject Information_CDLQI_cartoon_RO 1.0
Subject information and informed consent form (for publication) L2_Other subject Information_ItchQuant-RO N/A
Subject information and informed consent form (for publication) L2_Other subject information_material_Subject_ID_Card_BY_Redacted 1.0
Subject information and informed consent form (for publication) L2_Other subject information_material_Subject_ID_Card_RU_Redacted 1.0
Subject information and informed consent form (for publication) L2_other subject information_study_visit_guide_AU 2.0
Subject information and informed consent form (for publication) L2_Other subject Information_Subject_ID_RO_redact 1.0
Subject information and informed consent form (for publication) Other subject information material CDLQI For Publication NA
Subject information and informed consent form (for publication) Other subject information material FPS-R For Publication 3
Subject information and informed consent form (for publication) Other subject information material Global Visa Card For Publication NA
Subject information and informed consent form (for publication) Other subject information material ItchQuant For Publication NA
Subject information and informed consent form (for publication) Other subject information material Subject_ID_Card_POL For Publication 1.0
Subject information and informed consent form (for publication) Other subject information material_allo-APZ2-EB-III_Subject_ID_Card_Hungary_HUN_for publication 1.1
Subject information and informed consent form (for publication) Other subject Information material_CDLQI_cartoon_Italian NA
Subject information and informed consent form (for publication) Other subject Information material_CDLQI_Ita NA
Subject information and informed consent form (for publication) Other subject Information material_FPS-R_Ita NA
Subject information and informed consent form (for publication) Other subject Information material_GP letter_Italy_Extract_For Publication 1.2.0
Subject information and informed consent form (for publication) Other subject Information material_GP letter_Italy_For Publication 1.2.0
Subject information and informed consent form (for publication) Other subject Information material_ItchQuant_Ita NA
Subject information and informed consent form (for publication) Other subject Information material_Modello_Indennita_spese_sper_Extract_For publication NA
Subject information and informed consent form (for publication) Other subject Information material_Modello_Indennita_spese_sper_For publication NA
Subject information and informed consent form (for publication) Other subject Information material_Procedures for Reimbursement of expenses_FP 1.0
Subject information and informed consent form (for publication) Other subject Information material_Reimbursement Request Form_For Publication 1.0
Subject information and informed consent form (for publication) Other subject Information_Subject_ID_Ita_For Publication 1.0
Subject information and informed consent form (for publication) Other subject information_visit reminder card_AUT_DE-AT_for publication 1.0
Subject information and informed consent form (for publication) Patient questionnaire-allo-APZ2-EB-III_facepainscale_Hungarian NA
Subject information and informed consent form (for publication) Patient questionnaire-allo-APZ2-EB-III_ItchQuant_HUN NA
Subject information and informed consent form (for publication) SIS and ICF Adolescent Assent For Publication 2.2.0
Subject information and informed consent form (for publication) SIS and ICF Adolescent Assent For Publication_TC 2.2.0
Subject information and informed consent form (for publication) SIS and ICF Assent Ages 2 to 6 Years For Publication 1.2.0
Subject information and informed consent form (for publication) SIS and ICF Assent Ages 2 to 6 Years For Publication_TC 1.2.0
Subject information and informed consent form (for publication) SIS and ICF Assent Ages 7 to 12 Years For Publication 2.2.0
Subject information and informed consent form (for publication) SIS and ICF Assent Ages 7 to 12 Years For Publication_TC 2.2.0
Subject information and informed consent form (for publication) SIS and ICF Colpitts Clinical ICF For Publication 0.2.0
Subject information and informed consent form (for publication) SIS and ICF Colpitts Clinical ICF For Publication_TC 0.2.0
Subject information and informed consent form (for publication) SIS and ICF Main PIS-ICF For Publication 2.2.0
Subject information and informed consent form (for publication) SIS and ICF Main PIS-ICF For Publication_TC 2.2.0
Subject information and informed consent form (for publication) SIS and ICF Parent-Guardian IS-ICF For Publication 2.2.0
Subject information and informed consent form (for publication) SIS and ICF Parent-Guardian IS-ICF For Publication_TC 2.2.0
Subject information and informed consent form (for publication) SIS and ICF Pregnancy PIS-ICF For Publication 1.2.0
Subject information and informed consent form (for publication) SIS and ICF Pregnancy PIS-ICF For Publication_TC 1.2.0
Subject information and informed consent form (for publication) SIS and ICF Pregnant Partner IS-ICF For Publication 1.2.0
Subject information and informed consent form (for publication) SIS and ICF Pregnant Partner IS-ICF For Publication_TC 1.2.0
Subject information and informed consent form (for publication) SIS and ICF_ Adolescent Assent_Italy_Extract_FP 2.2.0
Subject information and informed consent form (for publication) SIS and ICF_Adult_Italy_Extract_For publication 2.2.0
Subject information and informed consent form (for publication) SIS and ICF_Optional Biopsy_Italy 1.1.0
Subject information and informed consent form (for publication) SIS and ICF_Parent_Italy_Extract_For publication 2.2.0
Subject information and informed consent form (for publication) SIS and ICF_Pregnancy and Birth_For publication 1.1.0
Subject information and informed consent form (for publication) SIS ICF 10-17yr_Austria_GER_TC_for publication 2.3.0
Subject information and informed consent form (for publication) SIS ICF 2-5yr_Austria_GER_TC_for publication 1.2.0
Subject information and informed consent form (for publication) SIS ICF 6-9yr_Austria_GER_TC_for publication 2.3.0
Subject information and informed consent form (for publication) SIS ICF Colpitts_Austria_GER_for publication 0.1.0
Subject information and informed consent form (for publication) SIS ICF Main_Austria_GER_TC_for publication 2.3.0
Subject information and informed consent form (for publication) SIS ICF Parent-Guardian_Austria_GER_TC_for publication 2.3.0
Subject information and informed consent form (for publication) SIS ICF Pregnancy_Austria_GER_for publication 1.2.0
Subject information and informed consent form (for publication) SIS ICF Pregnancy_Austria_TC_GER_for publication 1.2.0
Subject information and informed consent form (for publication) SIS ICF Pregnant Partner_Austria_GER_for publication 2.2.0
Subject information and informed consent form (for publication) SIS ICF Pregnant Partner_Austria_TC_GER_for publication 2.2.0
Subject information and informed consent form (for publication) Subject info and informed consent form allo-APZ2-EB-III_Colpitts ICF_HUN 1.1.0
Subject information and informed consent form (for publication) Subject info and informed consent form allo-APZ2-EB-III_Main ICF_HUN 2.2.0
Subject information and informed consent form (for publication) Subject info and informed consent form allo-APZ2-EB-III_Main ICF_HUN_Extract 2.2.0
Subject information and informed consent form (for publication) Subject info and informed consent form allo-APZ2-EB-III_Pregnancy ICF_HUN_Extract 1.2.0
Subject information and informed consent form (for publication) Subject_ID_Card_Austria_for publication 1.1.0
Synopsis of the protocol (for publication) allo-APZ2-EB-III_Protocol Synopsis_DE_2022-500266-10-00 3.0
Synopsis of the protocol (for publication) allo-APZ2-EB-III_Protocol Synopsis_DE_2022-500266-10-00_TC_for publication 3.0
Synopsis of the protocol (for publication) allo-APZ2-EB-III_Protocol Synopsis_NE_Dutch_2022-500266-10_TC 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis_HUN_2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1__allo-APZ2-EB-III Protocol Synopsis_GRE__2022-500266-10-00 4.0
Synopsis of the protocol (for publication) D1__Protocol Synopsis_ENG_2022-500266-10-00 4.0
Synopsis of the protocol (for publication) D1__Protocol Synopsis_FRA_2022-500266-10-00 4.0
Synopsis of the protocol (for publication) D1__Protocol synopsis_HRV_2022-500266-10-00 4.0
Synopsis of the protocol (for publication) D1__Protocol Synopsis_ITA_2022-500266-10-00 4.0
Synopsis of the protocol (for publication) D1__Protocol Synopsis_NE_Dutch_2022-500266-10-00 4.0
Synopsis of the protocol (for publication) D1__Protocol Synopsis_POL 2022-500266-10-00 4.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_AT 2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ENG_2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ESP_2022-500266-10-00 4.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_ESP_2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_FRA_2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_GRE_2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_HRV_2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ITA_2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_NE_Dutch_2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_POL 2022-500266-10-00 6.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_PRT_2022-500266-10-00 6.0

Application history

31 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-08-17 Austria Acceptable with conditions
2022-12-05
 2022-12-06
2 NON SUBSTANTIAL MODIFICATION NSM-2 2023-03-16 Austria Acceptable with conditions
2022-12-05
 2023-03-16
3 SUBSTANTIAL MODIFICATION SM-3 2023-05-05 Austria Acceptable
2023-07-14
 2023-07-17
4 NON SUBSTANTIAL MODIFICATION NSM-3 2023-08-29 Austria Acceptable
2023-07-14
 2023-08-29
5 NON SUBSTANTIAL MODIFICATION NSM-4 2023-09-14 Acceptable
2023-07-14
 2023-09-14
6 SUBSEQUENT ADDITION OF MSC APP-6 2023-09-18 Acceptable
2023-07-14
 2023-12-14
7 SUBSEQUENT ADDITION OF MSC APP-7 2023-09-18 2023-12-18
8 SUBSEQUENT ADDITION OF MSC APP-8 2023-09-26 2023-11-24
9 SUBSEQUENT ADDITION OF MSC APP-9 2023-09-26 Acceptable
2023-07-14
 2023-12-05
10 NON SUBSTANTIAL MODIFICATION NSM-5 2023-12-20 Austria Acceptable
2023-07-14
 2023-12-20
11 SUBSTANTIAL MODIFICATION SM-5 2024-03-13 Austria Acceptable
2024-06-17
 2024-06-17
12 SUBSTANTIAL MODIFICATION SM-6 2024-06-26 Acceptable 2024-07-11
13 SUBSTANTIAL MODIFICATION SM-7 2024-06-27 Acceptable 2024-07-09
14 SUBSTANTIAL MODIFICATION SM-8 2024-06-27 Acceptable 2024-08-28
15 SUBSTANTIAL MODIFICATION SM-10 2024-07-01 Acceptable 2024-07-29
16 SUBSTANTIAL MODIFICATION SM-11 2024-07-01 Acceptable 2024-07-04
17 SUBSTANTIAL MODIFICATION SM-12 2024-07-04 Acceptable 2024-08-26
18 SUBSTANTIAL MODIFICATION SM-13 2024-07-30 Acceptable 2024-09-20
19 SUBSTANTIAL MODIFICATION SM-14 2024-09-25 Austria Acceptable
2024-10-08
 2024-10-08
20 NON SUBSTANTIAL MODIFICATION NSM-6 2024-12-19 Acceptable
2024-10-08
 2024-12-19
21 NON SUBSTANTIAL MODIFICATION NSM-7 2024-12-24 Acceptable
2024-10-08
 2024-12-24
22 NON SUBSTANTIAL MODIFICATION NSM-8 2024-12-24 Acceptable
2024-10-08
 2024-12-24
23 SUBSTANTIAL MODIFICATION SM-15 2024-12-24 Acceptable 2025-02-17
24 SUBSTANTIAL MODIFICATION SM-16 2024-12-24 Acceptable 2025-02-19
25 SUBSTANTIAL MODIFICATION SM-17 2025-04-14 Acceptable 2025-05-20
26 SUBSTANTIAL MODIFICATION SM-18 2025-04-17 Acceptable 2025-06-30
27 SUBSTANTIAL MODIFICATION SM-19 2025-04-29 Acceptable 2025-07-03
28 NON SUBSTANTIAL MODIFICATION NSM-9 2025-07-04 Acceptable 2025-07-04
29 SUBSTANTIAL MODIFICATION SM-20 2025-07-30 Austria Acceptable
2025-11-03
 2025-11-05
30 NON SUBSTANTIAL MODIFICATION NSM-10 2025-12-02 Acceptable
2025-11-03
 2025-12-02
31 SUBSTANTIAL MODIFICATION SM-21 2026-02-20 Acceptable
2026-04-27
 2026-04-29

Related clinical trials