Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
60
Countries
7
Sites
21
Moderately to Severely Active Ulcerative Colitis
To demonstrate superiority of mirikizumab treatment compared to adult placebo in achieving MMS clinical remission among those who were clinical responders at Week 12
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 26 Feb 2024 → 1 May 2026
- Decision date (initial)
- 2024-01-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Eli Lilly and Company
External identifiers
- EU CT number
- 2022-502183-20-00
- WHO UTN
- U1111-1285-6928
- ClinicalTrials.gov
- NCT05784246
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacokinetic
To demonstrate superiority of mirikizumab treatment compared to adult placebo in achieving MMS clinical remission among those who were clinical responders at Week 12
Conditions and MedDRA coding
Moderately to Severely Active Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002208-PIP01-17
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Males or females weighing >10 kg and ≥2 and <18 years old
- Have moderate to severe UC
- Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, or Janus Kinase (JAK)-Inhibitor treatment
- Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report
Exclusion criteria 5
- Have Crohn’s disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis
- Have immune deficiency syndrome
- Previous bowel resection or intestinal surgery
- Evidence of toxic megacolon
- History or current evidence of cancer of the gastrointestinal tract
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants with Modified Mayo Score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Omvoh 300 mg concentrate for solution for infusion
PRD10448233 · Product
- Active substance
- Mirikizumab
- Substance synonyms
- LY-3074828
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC — -
- Marketing authorisation
- EU/1/23/1736/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical supply used in the clinical trial, please refer to the enclosed IMPD
Omvoh 100 mg solution for injection in pre-filled syringe
PRD10448234 · Product
- Active substance
- Mirikizumab
- Substance synonyms
- LY-3074828
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC — -
- Marketing authorisation
- EU/1/23/1736/002
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical supply used in the clinical trial, please refer to the enclosed IMPD
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 12
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Oracle America Inc. ORG-100039874
|
Redwood City, United States | E-data capture |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Greenfield, United States | Other |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100044131
|
Indianapolis, United States | Other, Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Iqvia Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 2, Code 5, Code 8 |
| Acelabio (US) Inc. ORG-100045270
|
San Diego, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
7 EU/EEA countries · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 2 | 2 |
| France | Ended | 4 | 4 |
| Germany | Ended | 3 | 3 |
| Italy | Ended | 3 | 3 |
| Netherlands | Ended | 2 | 2 |
| Poland | Ended | 14 | 5 |
| Portugal | Ended | 2 | 2 |
| Rest of world
Japan, United Kingdom, Canada, Israel, Korea, Republic of, United States, Australia
|
— | 30 | — |
Investigational sites
UZ Leuven
Pediatrics, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Pediatrics, Drie Eikenstraat 655, 2650, Edegem
Hospices Civils De Lyon
Hépatologie, gastro-entérologie et nutrition pédiatriques, 59 Boulevard Pinel, 69500, Bron
Assistance Publique Hopitaux De Paris
Nutrition et Gastro-entérologie Pédiatriques, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
Centre Hospitalier Universitaire Amiens Picardie
Pédiatrie, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Assistance Publique Hopitaux De Paris
Gastro-Entérologie Hépatologie et Nutrition pédiatrique, 149 Rue De Sevres, 75015, Paris
Helios Universitaetsklinikum Wuppertal
Zentrum für Kinder- und Jugendmedizin, Heusnerstrasse 40, Barmen, Wuppertal
Klinikum der Universitaet Muenchen AöR
Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital, Lindwurmstrasse 4, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts
Klinik und Poliklinik für Kinder- und Jugendmedizin, Gebaeude 605, Langenbeckstrasse 1, Mainz
Ospedale Pediatrico Bambino Gesu'
Epatogastroenterologia e Nutrizione, Piazza Sant'onofrio 4, 00165, Rome
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department of Maternal and Child Health / Pediatric Gastroenterology and Hepatology Unit, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliera Universitaria Meyer IRCCS
SOC Gastroenterologia e Nutrizione, Viale Gaetano Pieraccini 24, 50139, Florence
Amsterdam UMC
Kindergeenskunde, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Children Gastroenterology and Hepatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Gabinet Lekarski Bartosz Korczowski
Gastroenterology, ul. Litewska 4A/7, 35-302, Rzeszów
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkus, Ul. Plowiecka 103, 04-501, Warsaw
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Gastroenterology, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Instytut Pomnik Centrum Zdrowia Dziecka
Klinika Gastroenterologii, Hepatologii, Zaburzeń Odżywiania i Pediatrii, Aleja Dzieci Polskich 20, 04-730, Warsaw
Centrum Medyczne Oporow
N/A, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
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 |
|---|---|---|---|---|---|
| Belgium | 2024-05-09 | 2026-04-24 | 2024-06-04 | 2025-04-16 | |
| France | 2024-02-28 | 2025-06-25 | 2025-02-14 | 2025-04-16 | |
| Germany | 2024-03-27 | 2026-01-12 | 2024-03-27 | 2025-04-16 | |
| Italy | 2024-02-27 | 2025-07-15 | 2024-05-27 | 2025-04-16 | |
| Netherlands | 2024-05-31 | 2025-06-25 | 2024-05-31 | 2025-04-16 | |
| Poland | 2024-02-26 | 2026-03-17 | 2024-02-27 | 2025-04-16 | |
| Portugal | 2024-04-15 | 2025-06-25 | 2024-04-15 | 2025-04-16 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-IT-0001
- Member state
- Italy
- Publication date
- 2025-10-08
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-10-08
- Immediate action required
- Yes
- Notes
- Reverted (2025-10-08)
- Justification
- Dear Applicant,
Considering the expiration of the three-year mandate of the members of the National Ethics Committee (CEN) for clinical trials relating to advanced therapies (“ATMP”) and of the National Ethics Committee (CEN) for clinical trials in the pediatric field, appointed by Decree of the Minister of Health - 2 March 2022;
Considering the fact that, due to the expiration of the mandate of the members of the aforementioned National Ethics Committee (CEN), for the procedure in subject the assessment of the aspects relating to Part II of the evaluation report pursuant to art. 7 of the aforementioned Regulation (EU) No. 536/2014 has not been carried out, and as a result there is no conclusion of Part II for the EU CT 2022-502183-20-00 procedure (AIFA authorization provision n° 0106305);
In compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 193 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-502183-20_justification for inclusion of minors_red_san | N/A |
| Protocol (for publication) | D1_Protocol_2022-502183-20_red_san | c |
| Protocol (for publication) | D1_Protocol_2022-502183-20-justification for collection of full date of birth_red_san | N/A |
| Protocol (for publication) | D1_Protocol_2022-502183-20-justification for collection of race_red_san | N/A |
| Protocol (for publication) | D4_Patient facing documents_copyright memo_san | 1.0 |
| Recruitment arrangements (for publication) | K_1_Recruitment and consent Form_San | 3 |
| Recruitment arrangements (for publication) | K_2_Banner Ads_FR_San | NA |
| Recruitment arrangements (for publication) | K_2_Brochure 7-12_Red_San | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_san | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_san | 3.0 |
| Recruitment arrangements (for publication) | K1_I6T-MC-AMBA Recruitment Procedures_San | V2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_San | Italy |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 3 |
| Recruitment arrangements (for publication) | K1_Recrutiment arrangements_san | V3.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Banner Ads_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Doctor to Parent Guardian Letter_san | V02PRT01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Parent Guardian Brochure_san | V02PRT01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Parent Guardian Flyer_san | V02PRT01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Parent Guardian Study Guide_san | V03PRT01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Physician Referral Letter_san | V02PRT01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Social Media_Clinical Trial Posts_san | V02PRT01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Banner Ads_Dutch_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Banner Ads_English_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Banner Ads_French_san | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Doctor-to-Parent-Guardian Letter_Dutch_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Doctor-to-Parent-Guardian Letter_English_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Doctor-to-Parent-Guardian Letter_French_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Parent-Guardian Brochure_Dutch_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Parent-Guardian Brochure_English_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Parent-Guardian Brochure_French_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Parent-Guardian Flyer_Dutch_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Parent-Guardian Flyer_English_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Parent-Guardian Flyer_French_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Parent-Guardian Flyer_san | V02POL(pl) |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Physician Referral Brochure_Dutch_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Physician Referral Brochure_English_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Physician Referral Brochure_French_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Physician Referral Letter_Dutch_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Physician Referral Letter_English_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Physician Referral Letter_French_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Social Media_Clinical Trial Post_san | V02POL(pl) |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Social Media_Clinical Trial Posts_Dutch_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Social Media_Clinical Trial Posts_English_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Social Media_Clinical Trial Posts_French_san | V02BEL01 |
| Recruitment arrangements (for publication) | K2_Dr brochure_San | V02FRA(fr) |
| Recruitment arrangements (for publication) | K2_Dr to Parent Letter_San | V02FRAfr01 |
| Recruitment arrangements (for publication) | K2_I6T-MC-AMBA_Banner Ads_San | N/A |
| Recruitment arrangements (for publication) | K2_I6T-MC-AMBA_Doctor-to-Parent-Guardian Letter_San | V02NLD01 |
| Recruitment arrangements (for publication) | K2_I6T-MC-AMBA_Parent-Guardian Brochure_San | V02NLD(nl) |
| Recruitment arrangements (for publication) | K2_I6T-MC-AMBA_Parent-Guardian Flyer_San | V02NLD(nl) |
| Recruitment arrangements (for publication) | K2_I6T-MC-AMBA_Social Media Clinical Trial Posts_San | V02NLD(nl) |
| Recruitment arrangements (for publication) | K2_Parents Brochure_San | V02FRA(fr) |
| Recruitment arrangements (for publication) | K2_Parents Flyer_San | V02FRA(fr) |
| Recruitment arrangements (for publication) | K2_Physician Referral Letter_San | V02FRAfr01 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Parent-Guardian Study Guide_san | V04DEU(de) |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Brochure_san | V02PRT01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner Ads_san | POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Banner Ads_San | ITA(it) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Banner Ads_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Doc-to-Par-Guard Letter_san | V2DEUde1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor to Parent Guardian Letter_san | V02POL01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Doctor-to-Parent-Guardian Letter_San | V02 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_LilyClinicalTrials-7-12yr_Red-San | V1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Parent Guardian Brochure_san | V02POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Parent-Guardian Brochure_San | V02 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Parent-Guardian Brochure_san | V2DEU(de) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Parent-Guardian Flyer_San | V02 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Parent-Guardian Flyer_san | V2DEU(de) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Parent-Guardian Study Guide_San | V04ITA(it) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Parent-Guardian Study Guide_V02 ITA_it_san | V02 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Appreciation item_San | V01 EUR(en |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient ID Card_San | V01 ITA(it |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Brochure_san | V02POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician Referral Brochure_San | V02 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician Referral Brochure_san | V2DEU(de) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_san | V02POL01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician Referral Letter_San | V02 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician Referral Letter_san | V2DEUde1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Social Media_Clinical Trial Posts_San | V02 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Social Media_ClinTrialPosts_san | V2DEU(de) |
| Recruitment arrangements (for publication) | K2_Social media_San | V02FRA(fr) |
| Subject information and informed consent form (for publication) | L1_ Addendum n-1_red_san | V1.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_ ICF Sponsor Statement_san_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main 16 years or older_red_san | V3.0PRT4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Parental_red_san | V3.0PRT4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Summary of Changes 16-17_Red_San | V1.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Summary of Changes Parental_Red_San | V1.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Adolescent PP ICF_Dutch_san | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Adolescent PP ICF_English_san | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Adolescent PP ICF_French_san | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent 07-11 years ICF_Dutch_san_Redacted | V2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent 07-11 years ICF_English_san_Redacted | V2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent 07-11 years ICF_French_san_Redacted | V2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent 12-17 years ICF_Dutch_san_Redacted | V2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent 12-17 years ICF_English_san_Redacted | V2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent 12-17 years ICF_French_san_Redacted | V2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Parental ICF_Dutch_san_Redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Parental ICF_English_san_Redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Parental ICF_French_san_Redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Participant ICF_Dutch_san | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Participant ICF_English_san | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Participant ICF_French_san | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner ICF_Dutch_san | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner ICF_English_san | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner ICF_French_san | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Turning 18 ICF_Dutch_san_Redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Turning 18 ICF_English_san_Redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Turning 18 ICF_French_san_Redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_Assent 12-14_Red_San | V4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_Assent 15-17_Red_San | V4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_Assent 7-11_Red_San | V4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_I6T-MC-AMBA_Assent 12-15 ICF_Red_San | V2.0NLD4.0 |
| Subject information and informed consent form (for publication) | L1_I6T-MC-AMBA_Assent 6-11 ICF_Red_San | V2.0NLD4.0 |
| Subject information and informed consent form (for publication) | L1_I6T-MC-AMBA_Main ICF_Red_San | V3.0NLD4.0 |
| Subject information and informed consent form (for publication) | L1_I6T-MC-AMBA_Parental ICF_Red_San | V3.0NLD4.0 |
| Subject information and informed consent form (for publication) | L1_I6T-MC-AMBA_Summary of Changes ICF_Red_San | V1.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Assent ICF_12 to17_red-san | V2DEUde1 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Assent ICF_6 to11_red-san | V2DEUde1 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_FSR ICF_red-san | V1.0DEU1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_red-san | V3.0DEU2.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_V3-0DEUde3-0_14Feb2024_clean_red-san | V3.0DEU4.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Parental ICF_red-san | V3.0DEU2.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Parental ICF_V3-0DEUde3-0_14Feb2024_clean_red-san | V3.0DEU4.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_PP ICF_red-san | 1 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_SoC ICF_red-san | V1.0DEU1.0 |
| Subject information and informed consent form (for publication) | L1_Parental ICF_Red_San | V3.0FRA3.0 |
| Subject information and informed consent form (for publication) | L1_Pregnancy FU ICF_San | V3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-15_red_san | V2.0PRT4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 5-11_red_san | V2.0PRT4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Child 12-17 years old_red-san | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Child 6-11 years old_red-san | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_red-san | V3.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parental_red-san | V3.0POL3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant and Pregnant Partner_red_san | V1.0PRT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Pregnant Patient_PL | V1.0POL3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 13-17 yo_Red-San | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 6-12 yo_Red-San | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parental_Red-San | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_San | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC ICF_red-san | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_en_red | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_fr_red | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_nl_red | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_PL_redacted | V1.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 yo_Red-San | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_Turning 18 ICF_Red_San | V3.0FRA3.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Appreciation item_san | V01EUR(en) |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Comic Book_Dutch_san_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Comic Book_English_san_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Comic Book_French_san_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Non-Screening Collection Instructions_Dutch_san | V01BEL(nl) |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Non-Screening Collection Instructions_English_san | V01BEL(en) |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Non-Screening Collection Instructions_French_san | V01BEL(fr) |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Parent-Guardian Study Guide_Dutch_san | V01BELnl01 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Parent-Guardian Study Guide_English_san | V01BELen01 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Parent-Guardian Study Guide_French_san | V01BELfr01 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Appreciation item description_san | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient ID Card_Dutch_san | V01BEL(nl) |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient ID Card_English_san | V01BEL(en) |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient ID Card_French_san | V01BEL(fr) |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient ID Card_san | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Non-Screening Visit Fecal Sample Collection_san | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Screening Fecal Sample Collection_san | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Screening Collection Instructions_Dutch_san | V01BEL(nl) |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Screening Collection Instructions_English_san | V01BEL(en) |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Screening Collection Instructions_French_san | V01BEL(fr) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation items_san | V01EUR(en) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinicalTrials Print_san | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Comic Book_red-san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fecal Sample Collection Instr_Non-Screen_V01_san | V01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fecal Sample Collection Instr_Screening_V01_san | V01 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_GP Letter_Red-San | V2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Non-Screening Visit Fecal Sample Collection Instruction_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Non-Screening Visit Fecal Sample Collection Instructions_San | V01 ITA(it |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Parent-Guardian Study Guide_san | V04POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Parental-Guardian Study Guide_san | V01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Appreciation Item_san | V01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient ID Card_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient ID Card_san | V01 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Screening Fecal Sample Collection Instructions_San | V01 ITA(it |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Screening Visit Fecal Sample Collection Instruction_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Parent study guide_San | V03FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Patient ID Card_San | V01FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Stool Collection Instructions_out of selection_San | V01FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Stool Collection Instructions_selection_San | V01FRA(fr) |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis PT 2022-502183-20-00_Red_San | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502183-20-dutch_red_san | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502183-20-ENG_red_san | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502183-20-french_red_san | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502183-20-german_red_san | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502183-20-italian_red_san | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502183-20-polish_red_san | c |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-07 | France | Acceptable 2024-01-11
|
2024-01-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-21 | Acceptable | 2024-04-24 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-07 | Acceptable | 2024-07-15 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-12 | France | Acceptable | 2024-09-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-31 | France | Acceptable 2025-02-14
|
2025-02-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-30 | Acceptable | 2025-10-01 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-06-30 | Acceptable | 2025-08-18 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-06-30 | Acceptable | 2025-07-18 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-01 | Acceptable | 2025-10-01 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-06 | Acceptable | 2025-10-06 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-11-27 | France | Acceptable | 2025-11-27 |