Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
158
Countries
8
Sites
36
Dermatitis, Atopic
To describe long term safety of a range of doses and dosing regimens of GSK1070806 in participants with moderate to severe AtD
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 30 Oct 2024 → 29 Jul 2025
- Decision date (initial)
- 2024-07-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508474-29-00
- ClinicalTrials.gov
- NCT06447506
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To describe long term safety of a range of doses and dosing regimens of GSK1070806 in participants with moderate to severe AtD
Secondary objectives 1
- To evaluate the long-term efficacy of a range of doses and dosing regimens of GSK1070806 in participants with moderate to severe AtD
Conditions and MedDRA coding
Dermatitis, Atopic
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participants with a diagnosis of moderate to severe AtD who have completed the qualifying Ph2 parent GSK AtD studies, who, in the opinion of the investigator, may benefit from treatment with GSK1070806. Participant must be 18 years of age inclusive, or older at the time of signing the informed consent. Participant must sign and date an informed consent. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Exclusion criteria 1
- "Had study intervention permanently discontinued at any time during a qualifying Ph2 parent GSK AtD clinical study, or developed a medical condition that would preclude participation as per qualifying Ph2 parent GSK AtD clinical study protocol. Participants who, during their participation in qualifying Ph2 parent GSK AtD clinical study, developed an AE or an SAE based on laboratory parameters, physical examination, vital signs, ECG, medical history, which in the opinion of the Investigator could indicate that continued treatment with IMP may present an unreasonable risk for the participant.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- "Incidence of: • Adverse events (AEs) and discontinuation from study treatment due to AEs. • Serious adverse events (SAEs) and adverse events of special interest (AESI).
Secondary endpoints 2
- Achieving a response (for binary endpoints) at Weeks 16, 32, 48 and every 48 weeks thereafter: • IGA score of 0 or 1 • EASI Reduction of ≥75% from Baseline* • PP-NRS Reduction of ≥4 points
- Achieving a maintained response (for binary endpoints) for at least 16/32/48 and every 48 weeks thereafter after first response in: • IGA score of 0 or 1 • EASI Reduction of ≥75% from Baseline* PCFB in the EASI (continuous endpoint) at weeks 16, 32, 48 and every 48 weeks thereafter.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Humanised IGG1 Kappa Monoclonal Antibody Against Interleukin 18
PRD206418 · Product
- Active substance
- Humanised IGG1 Kappa Monoclonal Antibody Against Interleukin 18
- Substance synonyms
- GSK1070806, Aletekitug
- Pharmaceutical form
- INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Locally Sourced 0.9% Sodium Chloride
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
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Third parties 18
| Organisation | City, country | Duties |
|---|---|---|
| Creapharm Clinical Supplies ORG-100020131
|
Le Haillan, France | Code 14 |
| IL-CSM Clinical Supplies Management GmbH ORG-100019573
|
Loerrach, Germany | Code 14, Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | E-data capture |
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Other |
| C & M Trial Support S.L. ORG-100042841
|
Yaiza, Spain | Other |
| ZALARIS Deutschland GmbH ORG-100046893
|
Henstedt-Ulzburg, Germany | Other |
| Clinops Tomasz Lusawa ORL-000003666
|
Józefów, Poland | Other |
| Komtur Polska Sp. z o.o. ORG-100036131
|
Warsaw, Poland | Code 14 |
| Jumo Health USA Inc. ORG-100044054
|
New Haven, United States | Other |
| Sermes CRO ORG-100030576
|
Madrid, Spain | Other |
| Charles River Laboratories Montreal ULC ORG-100041009
|
Senneville, Canada | Laboratory analysis |
| Charles River Laboratories International Inc. ORG-100041066
|
Mattawan, United States | Laboratory analysis |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 12, Code 2, Code 8 |
| Corevitas LLC ORG-100042037
|
Waltham, United States | Other |
| Let Me Pay Sp. z o.o. ORG-100049608
|
Warsaw, Poland | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Highland Heights, United States | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Fm Richard Et Associes ORG-100042723
|
Paris, France | Other |
Locations
8 EU/EEA countries · 36 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 6 | 3 |
| Czechia | Ended | 5 | 4 |
| France | Ended | 7 | 3 |
| Germany | Ended | 11 | 5 |
| Greece | Ended | 3 | 2 |
| Italy | Ended | 12 | 6 |
| Poland | Ended | 10 | 6 |
| Spain | Ended | 12 | 7 |
| Rest of world
Mexico, Argentina, United States, Thailand, Korea, Republic of, Japan, Panama, Canada, China
|
— | 92 | — |
Investigational sites
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Medical Center Medconsult Pleven OOD
N/A, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Diagnostic And Consulting Center XXVIII-Sofia EOOD
N/A, Ilia Beshkov Street 1, 1528, Sofia
Fakultni Nemocnice Kralovske Vinohrady
Dermatovenerologická klinika 3. LF UK a FNKV, Srobarova 1150/50, Vinohrady, Prague 10
Pratia Pardubice a.s.
Pratia Pardubice a.s., Na Hrebenech II 1718/8, Nusle, Prague 4
Vseobecna Fakultni Nemocnice V Praze
Dermatovenerologická klinika 1. LF UK a VFN, U Nemocnice 499/2, Nove Mesto, Prague
Praglandia s.r.o.
n/a, Nadrazni 3368/30a, Smichov, Prague
Hopital Saint Louis
Dermatologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Dermatologie, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Centre Hospitalier Universitaire De Nice
Dermatologie, 151 Route De Saint Antoine, 06200, Nice
Universitaetsklinikum Muenster AöR
Zentrale Studienkoordination fuer innovative Dermatologie (ZiD), Von-Esmarch-Strasse 58, Sentrup, Muenster
Universitaetsklinikum Schleswig-Holstein AöR
Klinik fuer Dermatologie, Allergologie und Venerologie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Essen AöR
Klinik fuer Dermatologie, Venerologie und Allergologie, Hufelandstrasse 55, Holsterhausen, Essen
ISA Interdisciplinary Study Association GmbH
-, Rankestrasse 33/34, Charlottenburg, Berlin
MENSINGDERMAresearch GmbH
Dermatologisches Ambulatorium, Heegbarg 4, Poppenbüttel, Hamburg
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
1st Department of Venereal & Skin Disease, Dragoumi Ionos 5 I, 161 21, Athens
Ippokratio General Hospital Of Thessaloniki
Hospital of Skin and Venereal Diseases of Thessaloniki - 1st Department of Dermatology, Delfon 124, 546 43, Thessaloniki
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
UOS Dermatologia, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Dermatologia, Via Pietro Albertoni 15, 40138, Bologna
Careggi University Hospital
SOD Immunoallergologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
University Hospital Consorziale Policlinico
UOC Dermatologia e venerologia Universitaria, Piazzale Giulio Cesare 11, 70124, Bari
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Dermatologia, Largo Agostino Gemelli 8, 00168, Rome
Azienda Ospedaliero Universitaria Di Modena
SC Dermatologia, Largo Del Pozzo 71, 41124, Modena
Medesta Dermatologia I Medycyna Estetyczna Lekarz Danuta Dabrowska I Michal Dabrowski Sp. z o.o.
NA, Ul. Legionow 8/c, 82-300, Elblag
Futuremeds Sp. z o.o.
Futuremeds Targówek, Ul. Sw. Wincentego 93/7, 03-291, Warsaw
Pratia S.A.
Centrum Medyczne Pratia Chojnice, Ul. Przemyslowa 3, 89-600, Chojnice
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
NA, Al. Piastow 65/U5, 70-332, Szczecin
Gyncentrum Sp. z o.o.
NZOZ Holsamed- Oddział Libero, Ul. Tadeusza Kosciuszki 229, 40-600, Katowice
Uniwersytecki Szpital Kliniczny W Poznaniu
Uniwersytecki Ośrodek Wczesnych Faz, Ul. Dluga 1/2, 61-848, Poznan
Vithas Hospital Nosa Senora De Fatima
Dermatology, Via Norte 48, 36206, Vigo
Hospital Unviersitario Miguel Servet
Dermatology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Clinico San Cecilio
Dermatology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital General Universitario Reina Sofia
Dermatology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Y Politecnico La Fe
Dermatology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital General Universitario Dr. Balmis
Dermatology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario Puerta De Hierro De Majadahonda
Dermatology, Calle De Manuel De Falla 1, 28222, Majadahonda
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-11-18 | 2024-11-18 | 2025-04-08 | ||
| Czechia | 2024-12-17 | 2024-12-17 | 2025-04-08 | ||
| France | 2025-03-17 | 2025-03-17 | 2025-04-08 | ||
| Germany | 2024-11-27 | 2024-11-27 | 2025-04-08 | ||
| Greece | 2024-12-18 | 2024-12-18 | 2025-04-08 | ||
| Poland | 2024-10-30 | 2024-10-30 | 2025-04-08 | ||
| Spain | 2024-10-30 | 2024-10-30 | 2025-04-08 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2024-09-13
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- the sponsor is requested to submit a specific SM Part II only in France in order to update its CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results_2023-508474-29-00 SUM-127675
|
2026-04-07T10:52:29 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Layperson Summary of Results_2023-508474-29-00 | 2026-03-25T07:22:41 | Submitted | Laypersons Summary of Results |
Documents 123 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layperson Summary of Results_BG_2023-508474-29-00 | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_CZ_2023-508474-29-00 | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_DE_2023-508474-29-00 | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_EN_2023-508474-29-00 | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_ES_2023-508474-29-00 | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_FR_2023-508474-29-00 | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_GR_2023-508474-29-00 | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_IT_2023-508474-29-00 | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_PL_2023-508474-29-00 | 1 |
| Protocol (for publication) | D1_Protocol 2023-508474-29-00_EL_Redacted | 4.0 |
| Protocol (for publication) | D1_Protocol 2023-508474-29-00_EN_Redacted | P Am1 |
| Protocol (for publication) | D4_Diary Card_DLQI | 1 |
| Protocol (for publication) | D4_Diary Card_POEM_Redacted | 1 |
| Protocol (for publication) | D4_Diary Card_PROMIS | 1 |
| Protocol (for publication) | D4_Diary Card_WPAI-AD | N/A |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_1 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_10 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_11 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_12 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_13 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_14 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_15 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_16 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_17 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_18 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_19 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_2 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_20 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_21 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_22 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_23 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_24 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_25 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_26 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_27 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_28 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_29 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_3 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_30 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_31 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_32 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_33 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_4 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_5 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_6 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_7 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_8 | 1 |
| Protocol (for publication) | D4_Patient Facing Materials Disclosure Statement_9 | 1 |
| Protocol (for publication) | D4_Questionnaire_DLQI_BG_BG | N/A |
| Protocol (for publication) | D4_Questionnaire_DLQI_CZ_CS | N/A |
| Protocol (for publication) | D4_Questionnaire_DLQI_DE_DE | N/A |
| Protocol (for publication) | D4_Questionnaire_DLQI_EL_EL | N/A |
| Protocol (for publication) | D4_Questionnaire_DLQI_EN | N/A |
| Protocol (for publication) | D4_Questionnaire_DLQI_ES_ES | N/A |
| Protocol (for publication) | D4_Questionnaire_DLQI_FR_FR | N/A |
| Protocol (for publication) | D4_Questionnaire_DLQI_IT_IT | N/A |
| Protocol (for publication) | D4_Questionnaire_HADS_DE_DE_Redacted | N/A |
| Protocol (for publication) | D4_Questionnaire_POEM_BG_BG_Redacted | 3.0 |
| Protocol (for publication) | D4_Questionnaire_POEM_CZ_CS_Redacted | 3.0 |
| Protocol (for publication) | D4_Questionnaire_POEM_DE_DE_Redacted | 1 |
| Protocol (for publication) | D4_Questionnaire_POEM_EL_EL_Redacted | N/A |
| Protocol (for publication) | D4_Questionnaire_POEM_EN_Redacted | 3.0 |
| Protocol (for publication) | D4_Questionnaire_POEM_ES_ES_Redacted | 3.0 |
| Protocol (for publication) | D4_Questionnaire_POEM_FR_FR_Redacted | N/A |
| Protocol (for publication) | D4_Questionnaire_POEM_IT_IT_Redacted | 1.0 |
| Protocol (for publication) | D4_Questionnaire_PROMIS_EN | 1 |
| Protocol (for publication) | D4_Questionnaire_WPAI-AD_BG_BG | 2.1 |
| Protocol (for publication) | D4_Questionnaire_WPAI-AD_CZ_CS | 2.6 |
| Protocol (for publication) | D4_Questionnaire_WPAI-AD_DE_DE | 2.1 |
| Protocol (for publication) | D4_Questionnaire_WPAI-AD_EL_EL | 2.3 |
| Protocol (for publication) | D4_Questionnaire_WPAI-AD_EN | 2.0 |
| Protocol (for publication) | D4_Questionnaire_WPAI-AD_ES_ES | 2.1 |
| Protocol (for publication) | D4_Questionnaire_WPAI-AD_FR_FR | 2.2 |
| Protocol (for publication) | D4_Questionnaire_WPAI-AD_IT_IT | 2.4 |
| Protocol (for publication) | D4_Subject Card_BG | 1.0 |
| Protocol (for publication) | D4_Subject Card_CZ | 1.0 |
| Protocol (for publication) | D4_Subject Card_DE | 1.0 |
| Protocol (for publication) | D4_Subject Card_EL | 2.0 |
| Protocol (for publication) | D4_Subject Card_ES | 1.0 |
| Protocol (for publication) | D4_Subject Card_FR | 1.0 |
| Protocol (for publication) | D4_Subject Card_IT | 1.0 |
| Protocol (for publication) | D4_Subject Card_PL | 4.0 |
| Recruitment arrangements (for publication) | K1_No longer subject to publication statement | N/A |
| Recruitment arrangements (for publication) | K1_No longer subject to publication statement 2 | 1 |
| Recruitment arrangements (for publication) | K1_No longer subject to publication statement_1 | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure_No CCI PI | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure_No CCI PI | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_Trifold_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment_Brochure Trifold_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Trifold_redacted | 2 |
| Recruitment arrangements (for publication) | K2_Trifold_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Trifold_redacted | 2 |
| Recruitment arrangements (for publication) | K2_Trifold_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_triptych_redacted | 2 |
| Recruitment arrangements (for publication) | No longer subject to publication statement | 1 |
| Recruitment arrangements (for publication) | P1_No longer subject to publication statement 1 | 1 |
| Recruitment arrangements (for publication) | Recruitment and Informed consent procedure | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_GDPR_NO CCI | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional Future Research_NO CCI | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional SPQF Questionnaire_NO CCI | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Participant | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_Main_BG_ICF_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Main_ICF_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP_letter | 2.0 |
| Summary of results (for publication) | Summary of Results_2023-508474-29-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508474-29-00_BG_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508474-29-00_CZ_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508474-29-00_DE_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508474-29-00_EL_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508474-29-00_EN_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508474-29-00_ES_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508474-29-00_FR_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508474-29-00_IT_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508474-29-00_PL_Redacted | 4.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-20 | Germany | Acceptable 2024-07-12
|
2024-07-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-26 | Germany | Acceptable 2024-09-30
|
2024-09-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-08 | 2024-10-08 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-21 | Germany | Acceptable 2025-02-10
|
2025-02-10 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-20 | Germany | Acceptable 2025-02-10
|
2025-02-20 |