Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
360
Countries
5
Sites
24
Atopic Dermatitis Eczema
To evaluate the efficacy of lebrikizumab when used in combination with TCS treatment, compared with placebo, in participants with moderate-to-severe AD
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 12 Sep 2023 → 30 Oct 2025
- Decision date (initial)
- 2023-07-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501476-25-00
- WHO UTN
- U1111-1288-4581
- ClinicalTrials.gov
- NCT05559359
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Pharmacogenomic, Others, Efficacy
To evaluate the efficacy of lebrikizumab when used in combination with TCS treatment, compared with placebo, in participants with moderate-to-severe AD
Conditions and MedDRA coding
Atopic Dermatitis Eczema
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002536-PIP01-18
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Have Atopic Dermatitis for at least 6 months if younger than 6 years old or 1 year if older than 6 years.
- 6 months to 6 years old and weigh over 6 kilograms.
- 12 to 18 years old and weigh less than 40 kilograms.
- A parent or legal guardian must be able to sign the consent document and follow to the guidelines of the study.
- And meet other additional conditions at the time of the first visit.
Exclusion criteria 6
- Have been in a similar study with a similar drug or received a forbidden treatment within the last 2 - 8 weeks.
- Be pregnant or breastfeeding.
- Have had previous reaction to the study drug or the ointments or cremes used in this study.
- Have a severe or current infection that requires strong antibiotics.
- Have a history of or have a current disease, or type of illness that your doctor believes could affect your safety.
- Have an addiction to drugs or alcohol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline
- Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10216907 · Product
- Active substance
- Lebrikizumab
- Substance synonyms
- RO5490255, LY3650150
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
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 7
D07AD · Product
- Active substance
- Corticosteroids, Very Potent (Group IV)
- Pharmaceutical form
- -
- Route of administration
- TOPICAL
- Max daily dose
- 1 Other
- Max total dose
- 126 Other
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- D07AD — CORTICOSTEROIDS, VERY POTENT (GROUP IV)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
H02AB · Product
- Active substance
- Glucocorticoids
- Pharmaceutical form
- -
- Route of administration
- ORAL
- Max daily dose
- 48 mg milligram(s)
- Max total dose
- 1440 mg milligram(s)
- Max treatment duration
- 30 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB — GLUCOCORTICOIDS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
L04AX · Product
- Active substance
- Other Immunosuppressants
- Pharmaceutical form
- -
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX — OTHER IMMUNOSUPPRESSANTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
D07AA · Product
- Pharmaceutical form
- PHF00017MIG
- Route of administration
- TOPICAL
- Max daily dose
- 1 Other
- Max total dose
- 126 Other
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- D07AA — CORTICOSTEROIDS, WEAK (GROUP I)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
D11AH · Product
- Active substance
- Agents for Dermatitis, Excluding Corticosteroids
- Pharmaceutical form
- -
- Route of administration
- TOPICAL
- Max daily dose
- 1 Other
- Max total dose
- 126 Other
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH — AGENTS FOR DERMATITIS, EXCLUDING CORTICOSTEROIDS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
D07AB · Product
- Pharmaceutical form
- PHF00017MIG
- Route of administration
- TOPICAL
- Max daily dose
- 1 Other
- Max total dose
- 126 Other
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- D07AB — CORTICOSTEROIDS, MODERATELY POTENT (GROUP II)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
D07AC · Product
- Active substance
- Corticosteroids, Potent (Group Iii)
- Pharmaceutical form
- -
- Route of administration
- TOPICAL
- Max daily dose
- 1 Other
- Max total dose
- 126 Other
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- D07AC — CORTICOSTEROIDS, POTENT (GROUP III)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| WCG Clinical Inc. ORG-100040730
|
Plymouth Meeting, United States | Code 10 |
| Patient Advertising Guru Inc. ORG-100046268
|
Melville, United States | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Data management |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Chantilly, United States | Laboratory analysis |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
Locations
5 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 11 | 2 |
| France | Ended | 9 | 3 |
| Germany | Ended | 9 | 5 |
| Poland | Ended | 42 | 4 |
| Spain | Ended | 18 | 10 |
| Rest of world
Japan, Brazil, United States, Canada, Mexico, Argentina, Australia, Taiwan
|
— | 271 | — |
Investigational sites
Fakultni Nemocnice Bulovka
N/A, Budinova 67/2, Liben, Prague
Fakultni Nemocnice Brno
N/A, Cernopolni 9, Cerna Pole, Brno-Sever
Hopitaux Drome Nord
Dermatology, 607 Avenue Genev De Gaulle Anthonioz, 26100, Romans-Sur-Isere
Centre Hospitalier Universitaire De Nantes
Dermatology, 41 Rue Curie, 44093, Nantes Cedex 1
Centre Hospitalier Universitaire De Toulouse
Dermatology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
N/A, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Rosenpark Research GmbH
N/A, Rheinstrasse 14, 64283, Darmstadt
Universitaetsklinikum Frankfurt AöR
N/A, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Muenster AöR
N/A, Von-Esmarch-Strasse 58, Sentrup, Muenster
Thermalsole- Und Schwefelbad Bentheim GmbH
N/A, Am Bade 1, 48455, Bad Bentheim
Dermed Centrum Medyczne Sp. z o.o.
N/A, Ul. Piotrkowska 48, 90-265, Lodz
Evimed Sp. z o.o.
N/A, Ul. Jana Pawla Woronicza 16, 02-625, Warsaw
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
Diamond Clinic Sp. z o.o.
N/A, Ul. Stefana Rogozinskiego 6/u11, 31-559, Cracow
Hospital Universitario Quironsalud Madrid
Dermatología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De Gran Canaria Dr. Negrin
Dermatología, Barranco De La Ballena Sn, 35010, Las Palmas De Gran Canaria
Hospital Universitario La Paz
Dermatología, Paseo Castellana 261, 28046, Madrid
Complexo Hospitalario Universitario De Pontevedra
Dermatología, Calle Mourente S/n, 36164, Pontevedra
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Dermatología, Calle De Serrano 143, 28006, Madrid
Hospital De Manises
Dermatología, Avinguda De La Generalitat Valenciana 50, 46940, Manises
University Clinic Of Navarra
Dermatología, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario 12 De Octubre
Dermatología, Bloque D, Avenida De Cordoba S/n, Madrid
Sant Joan De Deu Barcelona Hospital
Dermatología, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Infantil Universitario Nino Jesus
Dermatología, Avenida Menendez Pelayo 65, 28009, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2023-10-24 | 2025-08-06 | 2024-01-30 | ||
| France | 2023-09-29 | 2024-10-18 | |||
| Germany | 2023-09-19 | 2025-04-28 | 2023-11-16 | ||
| Poland | 2023-10-12 | 2025-11-25 | 2023-10-30 | ||
| Spain | 2023-09-12 | 2025-10-30 | 2023-10-02 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-CZ-0001
- Member state
- Czechia
- Publication date
- 2025-10-01
- Type
- 3
- Reason
- 6
- Immediate action required
- Yes
- Justification
- The Sponsor states in section 10.11.1.7.1. Multiplicity Adjustment of the protocol amendment “h” dated 5 September 2025 that „The prespecified graphical multiple testing approach (Bretz et al. 2011) will be implemented to control the overall family-wise rate at a 2-sided significance level of 0.05 for the co-primary and key secondary endpoints for the analysis population as defined in Section 10.11.1.7.2.“. The Sponsor is asked to mention in the protocol amendment whether overall type 1 error probability (OT1EP) is controlled for both co-primary endpoints and for all key secondary endpoints or whether OT1EP is controlled for both co-primary endpoints and for only some key secondary endpoints. Further, section 10.11.1.7.1. Multiplicity Adjustment includes graphical testing scheme (GTS) for EMA which depicts testing hierarchy of certain endpoints together with alpha propagation rules. However, GTS for EMA includes several endpoints which seem not to be defined neither among key secondary endpoints nor among other secondary endpoints nor among exploratory endpoints in section 3. Objectives, Endpoints, and Estimands. Meaning of some of these endpoints can be rather guessed from abbreviations in GTS in section 10.11.1.7.1. Multiplicity Adjustment in cooperation with definition of endpoints in section 3. Objectives, Endpoints, and Estimands. More specifically, endpoints which can be rather guessed are CDLQI-6 W16 (which seems to be endpoint of at least 6-point improvement in Children’s Dermatology Life Quality Index score at Week 16), IGA 01 W4 (which seems to be endpoint of percentage of participants with an Investigator’s Global Assessment score 0 or 1 and a reduction of at least 2 points from baseline to Week 4), PNRS-4 W4 (which seems to be endpoint of percentage of participants with a Pruritus Numeric Rating Scale of at least 4 points at baseline who achieve at least 4-point reduction from baseline to Week 4), EASI-75 W4 (which seems to be endpoint of percentage of participants achieving at least 75% reduction from baseline in Eczema Area and Severity Index at Week 4) and EASI100 W16 (which seems to be percentage of participants achieving 100% improvement from baseline in Eczema Area and Severity Index at Week 16). Thus, the Sponsor is asked to provide in the protocol amendment either 1) change of key secondary endpoints in section 3. Objectives, Endpoints, and Estimands which reflect endpoints mentioned in GTS in section 10.11.1.7.1. Multiplicity Adjustment, or 2) change of part of GTS in section 10.11.1.7.1. Multiplicity Adjustment which reflects all key secondary endpoints mentioned in section 3. Objectives, Endpoints, and Estimands. Lastly, the Sponsor is asked to clearly describe in the protocol amendment abbreviations of all endpoints in GTS in section 10.11.1.7.1. Multiplicity Adjustment, i.e., IGA 01 W16, EASI75 W16, PNRS-4 W16, CDLQI-6 W16, IGA01 W4, PNRS-4 W4, EASI-75 W4 and EASI100 W16, to avoid any confusion which endpoints are analysed in GTS.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 143 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-501476-25-00__Redacted | h |
| Protocol (for publication) | D1_Protocol 2022-501476-25-00_Redacted | i |
| Protocol (for publication) | D4_Patient Documents Copyright Template | 1 |
| Protocol (for publication) | Justification to collect patients race or ethnicity data_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_List of planned sites_CZ | 1 |
| Recruitment arrangements (for publication) | K1_List of planned sites_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement Statement_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Recruitment poster_SP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trifold_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitement and ICF procedure_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AdGuru_Prescreener_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AdGuru_Refer a Friend Email Text_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AdGuru_Website_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ADorable_Recruitment Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ADorable_Recruitment Poster PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure Caregiver_Parent | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure-Parents-Caregivers_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Ads Text | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Google Ads | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Introduction Trifold_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_StudyIntroductionTrifold_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website Landing Page | 1.1 |
| Recruitment arrangements (for publication) | KGBI_Informed consent and patient recruitment procedure | 1.0 |
| Subject information and informed consent form (for publication) | Blanket Statement | 1 |
| Subject information and informed consent form (for publication) | Directions of Use_CT-FS-VIAL IFU | 1 |
| Subject information and informed consent form (for publication) | Directions of Use_CT-PSF-NSD IFU | 1 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard Msg Templates_ROW_CZ | 6 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard Travel Ref Guide for Subjects_CZ | 3 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Card_Carrier | 1 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Cardholder_FAQ_EU_CZ | 3 |
| Subject information and informed consent form (for publication) | Greenphire_EC_packet_w_Data_Laws_as_applied_to_GP_CZ | 6 |
| Subject information and informed consent form (for publication) | Greenphire_EU Generic ClinCard_CZ | 3 |
| Subject information and informed consent form (for publication) | Greenphire_Fee_Schedule_CZ | 4 |
| Subject information and informed consent form (for publication) | Greenphire_General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP_CZ | 2 |
| Subject information and informed consent form (for publication) | Greenphire_Travel Contact Card_CZ | 2 |
| Subject information and informed consent form (for publication) | ICF Addendum_Genetic research_Clean Redacted | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Assent form 15-17y_TC version_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | ICF_Assent form_12-14y_TC version_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | ICF_Assent_12-14_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | ICF_Assent_15-17_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | ICF_Caregiver_Clean_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | ICF_Caregiver_TC version_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | ICF_DPA_Adult_redacted | 1.1 |
| Subject information and informed consent form (for publication) | ICF_DPA_Parent_redacted | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Greenphire_Redacted | 1 |
| Subject information and informed consent form (for publication) | ICF_Greenphire_TC version | 1.1 |
| Subject information and informed consent form (for publication) | ICF_Main Adult_TC version_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | ICF_Main Parent_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | ICF_Main Parent_TC version_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | ICF_Main_Adult_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | ICF_Study Partner | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Assent for older children_TC_Spanish_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Main ICF for adults_TC_Spanish_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Main ICF for parents_TC_Spanish_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 17 years old_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 17 years old_Tracked changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form Older children_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form Older children_Tracked changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form Younger children_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form Younger children_Tracked changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire ICF for adults | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire ICF for parents | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 18 years old_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 18 years old_Tracked changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF for adults_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF for parents_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Older child assent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parental_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parental_Tracked changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Younger children assent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 15-17y_Highlighted_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_Highlighted_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_Highlighted_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF for parents_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF for parents_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parent_Highlighted_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_TC_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes for parents_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes for participants_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Reimbursement ICF for Parents_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and Reimbursement ICF for Parents_Tracked Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Reimbursement ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and Reimbursement ICF_Tracked Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L10_Other Subject information material_Greenphire Travel Contact Card | 3.0 |
| Subject information and informed consent form (for publication) | L11_Other Subject information material_General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP | 2.0 |
| Subject information and informed consent form (for publication) | L12_Other Subject information material_Poland_-_EC_packet_w_Data_Privacy_as_applied_to_GP | 8.0 |
| Subject information and informed consent form (for publication) | L13_Contact Card for Study Participants | 1.0 |
| Subject information and informed consent form (for publication) | L14_CT-FS-VIAL IFU | 1.0 |
| Subject information and informed consent form (for publication) | L15_CT-PFS-NSD IFU | 1.0 |
| Subject information and informed consent form (for publication) | L16_Info Re-insurance Conditions for Patient | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ Appointment Reminder Card | 1 |
| Subject information and informed consent form (for publication) | L2_CZ Flipchart Teens_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_CZ Study Passport_age group 13 to 17_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_CZ Study Passport_age group 7 to12_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_CZ Study Schedule Planner_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appointment Reminder Card PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Brochure-Parents-Caregivers_Master_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Direction for USE NSD | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Direction for USE VIAL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Card Carrier | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Cardholder | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Msg Templates | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Data Privacy | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic ClinCard | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Fee Schedule | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient emergency card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trial-Brochure_Master_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Copyright Template | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Copyright Template | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Copyright Template | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_IAFlipTeens_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Retention material_StudyPassport 13-17yr_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Retention material_StudyPassport 7-12 yr_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Retention material_StudySchedulePlanner_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Parent TC_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L3_SIS and ICF_Assent young child_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L3_SIS and ICF_Assent young child_TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L4_SIS and ICF_Assent old child_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L4_SIS and ICF_Assent old child_TC_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L5__Other Subject information material_Greenphire_ClinCard_Cardholder_FAQ_EU | 3.0 |
| Subject information and informed consent form (for publication) | L6_Other Subject information material_Greenphire_ClinCard_Card_Carrier | 1 |
| Subject information and informed consent form (for publication) | L7_Other Subject information material_ Greenphire_Fee_Schedule | 4.0 |
| Subject information and informed consent form (for publication) | L8_Other Subject information material_Polish Greenphire ClinCard Msg Templates - ROW | 6.0 |
| Subject information and informed consent form (for publication) | L9_Other Subject information material_Greenphire ClinCard Travel Ref Guide for Subjects | 3.0 |
| Subject information and informed consent form (for publication) | Patient Information Card | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2022-501476-25-00_Redacted | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2022-501476-25-00_Redacted | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2022-501476-25-00_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GE_2022-501476-25-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2022-501476-25-00_Redacted | i |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SP_2022-501476-25-00_Redacted | i |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-14 | Czechia | Acceptable with conditions 2023-07-03
|
2023-07-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-01 | Czechia | Acceptable 2023-09-08
|
2023-09-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-12 | Czechia | Acceptable 2024-02-23
|
2024-02-28 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-19 | Czechia | Acceptable 2024-02-23
|
2024-03-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-23 | Czechia | Acceptable 2024-06-19
|
2024-06-20 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-01 | Czechia | Acceptable 2025-02-24
|
2025-02-25 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-05-01 | Czechia | Acceptable with conditions 2025-08-07
|
2025-08-07 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-23 | Czechia | Acceptable with conditions 2025-08-07
|
2025-09-23 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-10-17 | Czechia | Acceptable 2025-12-10
|
2025-12-10 |