Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
510
Countries
10
Sites
35
Moderately to Severely Active Crohn's Disease
To evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC induction
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 10 Jun 2022 → ongoing
- Decision date (initial)
- 2024-07-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Janssen Research & Development, United States
External identifiers
- EU CT number
- 2023-504737-41-00
- EudraCT number
- 2020-006165-11
- ClinicalTrials.gov
- NCT05197049
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Dose response, Pharmacogenetic, Efficacy, Pharmacogenomic, Safety
To evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC induction
Conditions and MedDRA coding
Moderately to Severely Active Crohn's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10011401 | Crohn's disease | 100000004856 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transperancy. As noted on this site, requests for access to the study data can be submitted through Yale Open data Access (YODA) Project site at yoda.yale.edu
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Clinically active Crohn's disease or fistulizing Crohn's disease of at least 3 months duration
- Endoscopic evidence of active ileocolonic Crohn's disease
- Current treatment with oral corticosteroids and/or immunomodulators, OR history of failure to respond to or tolerate oral corticosteroids and/or immunomodulators, OR history of corticosteroid dependence, OR has previously demonstrated lack of initial response, lost response or were intolerant to 1 or more biologic agents.
Exclusion criteria 3
- Has a draining stoma or ostomy.
- Presence on screening endoscopy or history of adenomatous colonic polyps that were not removed.
- Has previously received a biologic agent targeting IL-12/23 or IL-23.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Clinical remission at Week 12
- Endoscopic response at Week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10890564 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
PRD2827309 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- INJECTION/INFUSION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Reify Health Inc. ORG-100049669
|
Boston, United States | Code 2 |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other, E-data capture |
| Eresearchtechnology Inc. ORG-100013039
|
Pittsburgh, United States | Other, E-data capture |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 12, Code 2, Data management, Code 9 |
Locations
10 EU/EEA countries · 35 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Ongoing, recruitment ended | 5 | 1 |
| Czechia | Ongoing, recruitment ended | 17 | 3 |
| France | Ended | 12 | 1 |
| Germany | Ongoing, recruitment ended | 14 | 2 |
| Hungary | Ongoing, recruitment ended | 12 | 2 |
| Italy | Ended | 3 | 2 |
| Lithuania | Ongoing, recruitment ended | 5 | 1 |
| Poland | Ongoing, recruitment ended | 134 | 19 |
| Slovakia | Ongoing, recruitment ended | 11 | 2 |
| Spain | Ended | 6 | 2 |
| Rest of world
Malaysia, Brazil, Japan, United States, Bosnia and Herzegovina, Korea, Republic of, China, Jordan, Taiwan, Israel, Australia, New Zealand, Turkey
|
— | 291 | — |
Investigational sites
Poliklinika Solmed d.o.o.
HR10003; Gastroenterology, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Vojenska Nemocnice Brno
CZ10001:Interni oddeleni, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Nemocnice Slany
CZ10006:Gastroenterologicko-endoskopicke oddeleni, Politickych Veznu 576, 274 01, Slany
Oblastní nemocnice Kladno, a.s.
CZ10005:Gastroenterologicke a endoskopicke centrum, Vancurova 1548, 27259, Kladno
Hospices Civils De Lyon
FR10006 Hépato-Gastroentérologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
CED-Studienzentrum Karlshorst
10012; Gastroenterologie, Ehrenfelsstrasse 46, 10318, Berlin-Karlshorst
MVZ Dachau
10020 : Endoscopy, Münchner Str. 64, 85221, Dachau
Semmelweis University
HU10008; Belgyógyászati és Haematológiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Obudai Egeszseguegyi Centrum Kft.
HU10006, Lajos Utca 74-76, 1036, Budapest III
Universita' Campus Bio-medico Di Roma
IT10001:UOC di Gastroenterologia, Via Alvaro Del Portillo 200, 00128, Rome
Ospedale San Raffaele S.r.l.
IT10011:Gastroenterologia ed Endoscopia digestiva, Via Olgettina 60, 20132, Milan
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
LT10001:Dept of Gastroenterology, Eiveniu G. 2, Kauno M. Sav., Kaunas
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
PL10031_NZOZ „Centrum Medyczne KERMED", Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Sonomed Sp. z o.o.
PL10050_Gastroenterology, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Vivamed Sp. z o.o.
PL10055_Gastroenterology, Ul. Zamiejska 17, 03-580, Warsaw
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
PL10022_Twoja Przychodnia SCM, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Centrum Medyczne Medyk Sp. z o.o.
PL10023_Gastroenterology, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
PL10039_Gastroenterology, Ul. Barska 13, 87-800, Wloclawek
Reumed Sp. z o.o.
PL10019_REUMED Zespol Poradni Specjalistycznych Filia nr 2, Ul. Onyksowa 10, 20-582, Lublin
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
PL10053_Twoja Przychodnia PCM, Ul. Marcelinska 92, 60-324, Poznan
Wojewodzki Szpital Specjalistyczny W Olsztynie
PL10021_Oddzial Gastroenterologiczny, Ul. Zolnierska 18, 10-561, Olsztyn
Melita Medical Sp. z o.o.
PL10040_Melita Medical, Ul. Strzegomska 2-4, 53-611, Wroclaw
Medical Network Sp. z o.o.
PL10048_WIP Warsaw IBD Point Profesor Kierkus, Ul. Plowiecka 103, 04-501, Warsaw
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
PL10043_Centrum Medyczne Plejady, Ul. Tadeusza Szafrana 5d / U2-U5, 30-363, Cracow
H-T.Centrum Medyczne Sp. z o.o. sp.k.
PL10057_H-T. CENTRUM MEDYCZNE - ENDOTERAPIA, Aleja Bielska 105, 43-100, Tychy
Mz Badania Slowik Zymla Sp. j.
PL10006_Gastroenterology, Ul. Ks. Alojzego Kozielka 8, 44-190, Knurow
Pro Life Medica Sp. z o.o.
PL10045_ETG Zamosc, Ul. Gesia 3, 22-400, Zamosc
Centrum Medyczne Med-Gastr Sp. z o.o.
PL10063_Gastroenterology, Ul. Mokra 4, 91-034, Lodz
Bodyclinic Sp. z o.o. sp.k.
PL10047_Gastroenterology, Ul. Ulica Jozefa Sierakowskiego 4/u3, 03-712, Warsaw
Vistamed & Vertigo Sp. z o.o.
PL10029_Vistamed, Ul Raclawicka 105 1b, 53-149, Wroclaw
Centrum Medyczne Lukamed Sp. z o.o.
PL10056_Centrum Medyczne Lukamed, Ul. Mickiewicza 39, 89-600, Chojnice
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 |
|---|---|---|---|---|---|
| Croatia | 2023-01-30 | 2023-02-13 | 2023-02-27 | ||
| Czechia | 2022-08-31 | 2022-10-03 | 2023-02-13 | ||
| France | 2022-08-31 | 2026-01-05 | 2022-12-01 | 2023-02-24 | |
| Germany | 2022-11-15 | 2023-01-31 | 2023-02-27 | ||
| Hungary | 2022-09-23 | 2022-09-29 | 2023-02-21 | ||
| Italy | 2022-11-16 | 2025-03-10 | 2023-01-31 | 2023-02-27 | |
| Lithuania | 2022-09-30 | 2022-11-08 | 2023-01-30 | ||
| Poland | 2022-06-10 | 2022-07-19 | 2023-02-27 | ||
| Slovakia | 2022-09-29 | 2022-10-20 | 2023-02-21 | ||
| Spain | 2022-10-25 | 2025-02-11 | 2022-12-12 | 2023-02-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 168 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Main_EN_2023-504737-41-00_Public | 3.0 |
| Protocol (for publication) | D4 SVK Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_CZE Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_CZE Subject Diary CDAI screening-wk 48 to wk 96_Public | 1.0 |
| Protocol (for publication) | D4_CZE Subject Diary CDAI screening-wk 48_Public | 1.0 |
| Protocol (for publication) | D4_CZE Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_CZE Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_CZE Subject Materials IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_CZE Subject Materials IFU ultrasafe Plus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_CZE Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_DEU Subject Diary CDAI screening-wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Diary CDAI screening-wk 48_Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_DEU Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_DEU Subject Materials IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_ESP Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_ESP Subject Diary CDAI screening-wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_ESP Subject Diary CDAI screening-wk 48_Public | 1.0 |
| Protocol (for publication) | D4_ESP Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_ESP Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_ESP Subject Materials IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_ESP Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_ESP Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_FRA Subject Diary CDAI screening-wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Diary CDAI screening-wk 48_Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_FRA Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_FRA Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_HRV Subject Diary CDAI screening wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Diary CDAI screening wk 48_Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Materials AH instructions scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_HRV Subject Materials AH instructions screening visit_Public | 2.1 |
| Protocol (for publication) | D4_HRV Subject Materials IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_HUN Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_HUN Subject Diary CDAI screening - wk 48_Public | 1.0 |
| Protocol (for publication) | D4_HUN Subject Diary CDAI screening-wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_HUN Subject Material IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_HUN Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_HUN Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_HUN Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_HUN Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_IT10007 ITA Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_IT10012 ITA Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_IT10012 ITA Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_IT10012 ITA Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_ITA Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_ITA Subject Diary CDAI screening-wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_ITA Subject Diary CDAI screening-wk 48_Public | 1.0 |
| Protocol (for publication) | D4_ITA Subject Materials IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_LTU Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_LTU Subject Diary CDAI screening-wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_LTU Subject Diary CDAI screening-wk 48_Public | 1.0 |
| Protocol (for publication) | D4_LTU Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_LTU Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_LTU Subject Materials IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_LTU Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_LTU Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_POL Subject Diary CDAI screening-wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Diary CDAI screening-wk 48_Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_POL Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_POL Subject Materials IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_Regulatory Filenote Transparency Placeholder for Public Documents | NA |
| Protocol (for publication) | D4_Subject Diary AHA IMP diary_Public | 1.0 |
| Protocol (for publication) | D4_Subject Diary CDAI screening-wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_Subject Diary CDAI screening-wk 48_Public | 1.0 |
| Protocol (for publication) | D4_Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_Subject Materials IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_Subject Materials IMP instructions_Public | 1.0 |
| Protocol (for publication) | D4_SVK Subject Diary AHA IMP diary_Public | 2.0 |
| Protocol (for publication) | D4_SVK Subject Diary CDAI screening-wk 48 to 96_Public | 1.0 |
| Protocol (for publication) | D4_SVK Subject Diary CDAI screening-wk 48_Public | 1.0 |
| Protocol (for publication) | D4_SVK Subject Materials AH stool collection scheduled visit_Public | 2.1 |
| Protocol (for publication) | D4_SVK Subject Materials AH stool collection screening visit_Public | 2.1 |
| Protocol (for publication) | D4_SVK Subject Materials IFU Autoinjector 2ml_Public | 1.0 |
| Protocol (for publication) | D4_SVK Subject Materials IFU ultrasafePlus 1ml_Public | 1.0 |
| Protocol (for publication) | D4_SVK Subject Materials IMP instructions_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_NTF_Recruitment arrangements_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment Ntf | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment NtF_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment NtF_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment NtF_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment NtF_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment NtF_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Regulatory NtF Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Regulatory NtF_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Regulatory NtF_Public | NA |
| Recruitment arrangements (for publication) | K1_Regulatory Filenote Recruitment Public | NA |
| Subject information and informed consent form (for publication) | L1_ ICF Main Tracking Information COT-COV _Public | NA |
| Subject information and informed consent form (for publication) | L1_Country ICF procedure_Public | NA |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Already enrolled Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_CZE ICF Other Adult Child Follow-Up Public | 1 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Genetic Research Croatian Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Main Croatian Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Other 12 Mo Pregnancy FU Public | 1 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Other Pregnant Participant Croatian Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Other Pregnant Partner Croatian Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Research Croatian Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Other Adult 12 M Post-Birth FU Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Child Follow-Up Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research Adult_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research Adult_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research PIS_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic Research_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult_Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult_Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main PIS_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Lithuanian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Russian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other Adult Child Follow-Up Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Other Adult Pregnant Partner_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Other Adult_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other Pregnant Partner IS_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Other Pregnant Partner_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Other Pregnant Partner_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other Pregnant Partner_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Other_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Privacy_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Privacy_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Research_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Research_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Research_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_IRB-IEC Additional-Amendment Approval_Public | NA |
| Subject information and informed consent form (for publication) | L1_Main ICF Russian COT Public | NA |
| Subject information and informed consent form (for publication) | L2_HUN_List of submitted documents | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject ID Card justification letter_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Participation Card_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Participation Card_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2023-504737-41-00_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2023-504737-41-00_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ESP_2023-504737-41-00_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-504737-41-00_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HU_2023-504737-41-00_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-504737-41-00_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LT_2023-504737-41-00_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_POL_2023-504737-41-00_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Slovak_2023-504737-41-00_Public | 3.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-17 | Germany | Acceptable with conditions 2024-07-18
|
2024-07-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-22 | Germany | Acceptable 2025-02-20
|
2025-02-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-29 | Acceptable 2025-02-20
|
2025-04-29 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-07 | Germany | Acceptable 2025-09-08
|
2025-09-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-24 | Germany | Acceptable 2026-01-14
|
2026-01-14 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-03 | Germany | Acceptable 2026-01-14
|
2026-02-03 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-10 | Acceptable | 2026-05-11 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-10 | Acceptable | 2026-03-13 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-17 | Germany | Acceptable | 2026-03-24 |