Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
260
Countries
7
Sites
66
Ulcerative Colitis (UC)
To evaluate the efficacy of vixarelimab compared to placebo in the induction of clinical remission at Week 12
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 16 May 2024 → 17 Jun 2025
- Decision date (initial)
- 2024-04-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Genentech Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Efficacy, Others
To evaluate the efficacy of vixarelimab compared to placebo in the induction of clinical remission at Week 12
Secondary objectives 4
- To evaluate the efficacy of vixarelimab compared with placebo in the induction of clinical response, endoscopic improvement, and endoscopic remission
- To evaluate the safety of vixarelimab compared with placebo
- To characterize the pharmacokinetics of vixarelimab
- To evaluate the immune response to vixarelimab
Conditions and MedDRA coding
Ulcerative Colitis (UC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A PHASE II, STUDY WITH EXTENSION TO EVALUATE VIXARELIMAB IN PATIENTS WITH ULCERATIVE COLITIS This is a Phase II, multicenter, randomized, parallel-group, double-blind, placebo controlled, dose ranging study to evaluate the efficacy, safety, and pharmacokinetics of vixarelimab in patients with active moderate to severe UC, including 1) patients who have demonstrated inadequate
response to, loss of response to, or intolerance to prior advanced therapy which includes biologics and targeted small molecules advanced failures), and 2) patients who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional therapies
(corticosteroids and/or immunosuppressants) but have not failed advanced therapy (conventional failures).
|
Randomised Controlled | Double | [{"id":125399,"code":3,"name":"Monitor"},{"id":125401,"code":2,"name":"Investigator"},{"id":125400,"code":1,"name":"Subject"}] | 1.: Vixarelimab versus Placebo + Optional Active Treatment Extension |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- N/A
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-502828-42-00 | A Two-Cohort, Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vixarelimab Compared with Placebo in Patients with Idiopathic Pulmonary Fibrosis and in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease | Genentech Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Diagnosis of UC for at least 3 months
- Moderately to severely active UC, assessed by Modified Mayo Score (mMS)
- Inadequate response, loss of response to, or intolerance to conventional or advanced therapies for UC
Exclusion criteria 4
- Diagnosis of Crohn’s disease or indeterminate colitis
- Suspicion of ischemic, radiation, microscopic, or infectious colitis
- Prior colectomy
- Inadequate response to or loss of response to previous treatment of UC with Janus kinase (JAK) inhibitors.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Clinical remission at Week 12, with clinical remission defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore = 0, endoscopy subscore ≤ 1
Secondary endpoints 6
- 1. Clinical response at Week 12, with clinical response defined as decrease from baseline in the mMS of ≥ 2 and ≥ 30% reduction from baseline, with either a decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1
- 2. Endoscopic improvement at Week 12, with endoscopic improvement defined as a Mayo endoscopy subscore of ≤ 1 (score of 1 modified to exclude friability)
- 3. Endoscopic remission at Week 12, with endoscopic remission defined as a Mayo endoscopy subscore of 0
- 4. Incidence and severity of adverse events, with severity determined according to the DAIDS toxicity grading scale
- 5. Serum concentration of vixarelimab at specified timepoints
- 6. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10193830 · Product
- Active substance
- Vixarelimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- 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 10
-
H02A · Product
- Pharmaceutical form
- -
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02A — CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
D07A · Product
- Pharmaceutical form
- -
- Route of administration
- ORAL
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- D07A — CORTICOSTEROIDS, PLAIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP16294414 · ATC
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — INFLIXIMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP20047980 · ATC
- Active substance
- Adalimumab
- Substance synonyms
- ABP 501, BI 695501, MSB11022
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — ADALIMUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
A07EC · Product
- Pharmaceutical form
- PHF00006MIG
- Route of administration
- RECTAL USE
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A07EC — AMINOSALICYLIC ACID AND SIMILAR AGENTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
A07AX · Product
- Pharmaceutical form
- PHF00082MIG
- Route of administration
- ORAL
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A07AX — OTHER INTESTINAL ANTIINFECTIVES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13827298 · ATC
- Active substance
- Mercaptopurine
- Substance synonyms
- MERCAPTOPURINE ANHYDROUS, 3,7-DIHYDROPURINE-6-THIONE, 6-MERCAPTOPURINE, 6MP
- Route of administration
- ORAL
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB02 — MERCAPTOPURINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP34000237 · ATC
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AB06 — GOLIMUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129075 · ATC
- Active substance
- Azathioprine
- Route of administration
- ORAL
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX01 — AZATHIOPRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1034223 · ATC
- Active substance
- Methotrexate Sodium
- Substance synonyms
- SODIUM METHOTREXATE, MTX SODIUM
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 1 DF dosage form
- Max total dose
- 1 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX03 — METHOTREXATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4918
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Interactive response technologies (IRT) |
| PPD Global Ltd. ORG-100007531
|
Marousi, Greece | On site monitoring, Code 12 |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| PPD Development L.P. ORG-100011560
|
Wilmington, United States | On site monitoring, Code 12, Other, Code 2, Code 8 |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other |
Locations
7 EU/EEA countries · 66 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 8 | 2 |
| Czechia | Ended | 3 | 6 |
| France | Ended | 11 | 4 |
| Germany | Ended | 9 | 6 |
| Greece | Ended | 8 | 6 |
| Italy | Ended | 18 | 11 |
| Poland | Ended | 81 | 31 |
| Rest of world
United Kingdom, Taiwan, Mexico, Argentina, Brazil, Korea, Republic of, United States, Israel, Serbia, Canada, China
|
— | 122 | — |
Investigational sites
CHU Saint Pierre
Gastroenterology, Hoogstraat 322, 1000, Brussels
UZ Leuven
Department of Gastroenterology & Hepatology, Herestraat 49, 3000, Leuven
Hepato-Gastroenterologie HK s.r.o.
N/A, Trida Edvarda Benese 1549/34, 500 12, Hradec Kralove
PreventaMed s.r.o.
Vila zdraví, Interní ambulance, Domovina 774/2, 779 00, Olomouc
SurGal Clinic s.r.o.
N/A, Drobneho 307/38, Cerna Pole, Brno-Sever
Endohope klinika s.r.o.
N/A, Obloukova 1335/3, Vrsovice, Prague
Iscare a.s.
N/A, Ceskomoravska 2510/19, Liben, Prague
Vojenska Nemocnice Brno
N/A, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Hospices Civils De Lyon
Hepato-Gastroenterology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
CHRU De Nancy
Clinical Investigation Unit, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Nice
Gastroenterology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Saint Etienne
Gastroenterology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin I CED-Studienambulanz, Albert-Einstein-Allee 23, Eselsberg, Ulm
Martin-Luther-Universitaet Halle-Wittenberg
Universitätsklinik und Poliklinik für Innere Medizin I, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30, Lichterfelde, Berlin
Medical Center - University Of Freiburg
Klinik für Innere Medizin II, Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Schleswig-Holstein AöR
Campus Kiel Entzündungszentrum, Haus K1, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaet Muenster
Medizinische Klinik B Gastroenterologie, Hepatologie, Endokrinologie, Klinische Infektiologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Evangelismos S.A.
Gastroenterology Department, Ipsiladou 45-47, 106 76, Athens
Thoracic General Hospital Of Athens I Sotiria
3rd University Department of Internal Medicine, Gastroenterology Unit, Messogion Avenue 152, 115 27, Athens
Alexandra Hospital
Hepato-Gastroenterology Department, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Of Heraklion
Gastroenterology Department, Stavrakia And Voutes, 715 00, Heraklion
Geniko Nosokomeio Peiraia Tzaneio
Gastroenterology Department, Zanni And Afentouli Street, 185 36, Piraeus
Athens Medical Center S.A.
Gastroenterology Department, Areos 36, 175 62, Paleo Faliro
Ospedale San Raffaele S.r.l.
Gastroenterology and Endoscopic Unit, Via Olgettina 60, 20132, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Medicina Interna e Gastroenterologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Ordine Mauriziano Di Torino
Digestive endoscopy, Via Ferdinando Magellano 1, 10128, Turin
Fondazione IRCCS Policlinico San Matteo
S C. General Medicine I, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
U.O.S.D. Malattie Infiammatorie Croniche dell’Intestino, Via Trabucco 180, 90146, Palermo
Humanitas Research Hospital
Department of Biomedical Sciences Humanitas University, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera di Padova
Department of Surgery, Oncology and Gastroenterology, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliero-Universitaria Di Cagliari
Scienze Mediche e Sanità Pubblica, Strada Statale 554 N. 1, 09042, Monserrato
ASST Fatebenefratelli Sacco
UOC Gastroenterologia, Piazzale Principessa Clotilde 3, 20121, Milan
IRCCS Ospedale Sacro Cuore Don Calabria
Gastroenterolgy – IBD Unit, Via Don Angelo Sempreboni 5, 37024, Negrar
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Medico chirurgico delle malattie digestive, epatiche ed endocrino-metaboliche, Via Pietro Albertoni 15, 40138, Bologna
Mz Badania Slowik Zymla Sp. j.
N/A, Ul. Ks. Alojzego Kozielka 8, 44-190, Knurow
Clinical Trials Umed Sp. z o.o.
N/A, Bud A-2, Ul. Pomorska 251, Lodz
Vistamed & Vertigo Sp. z o.o.
n/a, Ul Raclawicka 105 1b, 53-149, Wroclaw
Planetmed Sp. z o.o.
n/a, Ul. Lubinowa 12/8, 52-210, Wroclaw
Nzoz For Med Sp. z o.o.
N/A, Ul. Lwowska 93, 34-100, Wadowice
Endoskopia Sp. z o.o.
N/A, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Santa Sp. z o.o. sp.k.
n/a, Ul. Zagorska 20/26, 25-355, Kielce
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
N/A, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Medical Network Sp. z o.o.
n/a, Ul. Plowiecka 103, 04-501, Warsaw
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.
N/A, Ul. Topolowa 33/7, 31-506, Cracow
EuroMediCare Szpital Specjalistyczny z Przychodnia
N/A, Ul. Pilczycka 144/148, 54-144, Wrocław
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
N/A, Ul. Zamiejska 17, 03-580, Warszawa
Eb Group Sp. z o.o.
N/A, Ul. Inflancka 4a, 00-189, Warsaw
Twoja Przychodnia - Opolskie Centrum Medyczne
N/A, ul. Kurpiowska 6/2, 45-819, Opole
Bonifraterskie Centrum Medyczne Sp. z o.o.
n/a, Ul. Kosynierow Gdynskich 61, 93-357, Lodz
Centrum Medyczne Uno-Med Sp. z o.o.
N/A, Ul. Gumniska 11, 33-100, Tarnow
Sonomed Sp. z o.o.
N/A, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Allmedica Badania Kliniczne Sp. z o.o.
N/A, Ul. Kowaniec 2a, 34-400, Nowy Targ
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
n/a, Os. Lecha 15a, 61-293, Poznan
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie
N/A, Ul. Aleje Raclawickie 23, 20-049, Lublin
Medrise Sp. z o.o.
N/A, Ul. Onyksowa 10, 20-582, Lublin
Manermed Sp. z o.o.
N/A, Ul. Garbary 5/l4, 85-229, Bydgoszcz
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
N/A, Ul. Woloska 137, 02-507, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej
N/A, Ul. Krasnystawska 52, 21-010, Leczna
Rivermed Sp. z o.o.
N/A, Ul. 28 Czerwca 1956 R. Nr 382/u4, 61-441, Poznan
Etg Zamosc Sp. z o.o.
N/A, Ul. Spadek 41, 22-400, Zamosc
Osrodek Badan Klinicznych Bd Research Sp. z o.o.
n/a, Ul. Gen. Wladyslawa Andersa 3, 14-200, Ilawa
Trialmed Sp. z o.o.
N/A, Ul. Rzemieslnicza 33, 97-300, Piotrkow Trybunalski
Melita Medical sp. z o.o.
N/A, Ul. Strzegomska 2-4 53-611 Wrocław, 53-611, Wrocław
Wsd Medi Clinical Sp. z o.o.
N/A, Aleja Jana Rodowicza Anody 22, 02-786, Warsaw
Eskulap Pabianice Sp. z o.o.
N/A, Ul. Grobelna 8, 95-200, Pabianice
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 | 2024-06-13 | ||||
| Czechia | 2024-07-31 | 2024-10-16 | 2025-03-27 | ||
| France | 2024-06-18 | 2025-03-27 | 2024-10-23 | 2025-03-27 | |
| Germany | 2024-09-18 | ||||
| Greece | 2024-06-01 | 2024-06-27 | 2025-03-27 | ||
| Italy | 2024-06-28 | 2024-09-30 | 2025-03-27 | ||
| Poland | 2024-05-16 | 2024-05-28 | 2025-03-27 |
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 |
|---|---|---|---|
| GA44839_CTIS Results Summary SUM-118570
|
2026-02-10T10:01:52 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| LPS GA44839_Final Results | 2026-01-13T15:24:36 | Submitted | Laypersons Summary of Results |
Documents 110 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | LPS GA44839_Final Results_November 2025_Czech-Czechia | NA |
| Laypersons summary of results (for publication) | LPS GA44839_Final Results_November 2025_English | NA |
| Laypersons summary of results (for publication) | LPS GA44839_Final Results_November 2025_French-France | NA |
| Laypersons summary of results (for publication) | LPS GA44839_Final Results_November 2025_Greek-Greece | NA |
| Laypersons summary of results (for publication) | LPS GA44839_Final Results_November 2025_Italian-Italy | NA |
| Laypersons summary of results (for publication) | LPS GA44839_Final Results_November 2025_Polish-Poland | NA |
| Protocol (for publication) | D1_Protocol 2023-506655-19-00 Redacted | 2 |
| Protocol (for publication) | D1_Protocol 2023-506655-19-00 Redacted GR | 1 (EEA) |
| Protocol (for publication) | d1_protocol-2023-506655-19-00-redacted EEA | 2(EEA) |
| Protocol (for publication) | D4_Patient facing documents_PatientCard_EL_Placeholder Redactions | 1 |
| Protocol (for publication) | D4_Patient facing documents_PatientCard_EN_Placeholder Redactions | 1 |
| Protocol (for publication) | D4_Patient facing documents_Redaction_Memo | 3 |
| Recruitment arrangements (for publication) | K1_GA44839_Justification of ethnicity collection_FR_English_Public | n/a |
| Recruitment arrangements (for publication) | K1_GA44839_Recruitment_Arrangements_IT_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_GA44839_Recruitment-and-Informed-consent-procedure_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K1_GA44839_Recruitment-Arrangements_DE_Public | n/a |
| Recruitment arrangements (for publication) | K1_GA44839_Recruitment-Arrangements_GRC_English_Public | 1 |
| Recruitment arrangements (for publication) | K1_GA44839_Recruitment-Arrangments_BE_Public | n/a |
| Recruitment arrangements (for publication) | K1_GA44839_Recruitment-Arrangments_CZE_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_GA44839_Recruitment-Informed-Consent-Procedure_FR_French_Public | N/A |
| Recruitment arrangements (for publication) | K2_ GA44839_Referring_Physicians_Information_Sheet_DE_German_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_GP-Letter_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_GA44839_Information for Referring Physicians_IT_Italian_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_GA44839_Recruitment Poster_BE_Dutch_Public | n/a |
| Recruitment arrangements (for publication) | K2_GA44839_Recruitment Poster_BE_English_Public | n/a |
| Recruitment arrangements (for publication) | K2_GA44839_Recruitment Poster_BE_French_Public | n/a |
| Recruitment arrangements (for publication) | K2_GA44839_Recruitment poster_FR_French_Public | n/a |
| Recruitment arrangements (for publication) | K2_GA44839_Recruitment_Poster_CZE_Czech_Public | n/a |
| Recruitment arrangements (for publication) | K2_GA44839_Recruitment_Poster_DE_German_Public | n/a |
| Recruitment arrangements (for publication) | K2_GA44839_Recruitment-Poster_GRC_Greek_Public | n/a |
| Recruitment arrangements (for publication) | K2_GA44839_Recruitment-Poster_PL_Polish_Public | n/a |
| Recruitment arrangements (for publication) | K2_GA44839_Recuitment_Poster_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_GA44839_Referring Physicians Information Sheet_BE_Dutch_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Referring Physicians Information Sheet_BE_English_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Referring Physicians Information Sheet_BE_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Referring Physicians Information Sheet_FR_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Referring_Physicians_Information_Sheet_CZE_Czech_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Referring-Physicians-Information-Sheet_GRC_Greek_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Referring-Physicians-Information-Sheet_PL_Polish_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Your Trial Journey_FR_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Your Trial Journey_IT_Italian_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_GA44839_Your Trial Yourney_BE_Dutch_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Your Trial Yourney_BE_English_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Your Trial Yourney_BE_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Your_Trial_Journey_CZE_Czech_Czech_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Your_Trial_Journey_DE_German_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Your-Trial-Journey_GRC_Greek_Public | 2 |
| Recruitment arrangements (for publication) | K2_GA44839_Your-Trial-Journey_PL_Polish_Public | 2 |
| Subject information and informed consent form (for publication) | L1_GA44839_Data Privacy Information Sheet_CZE_Czech_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Greenphire_ICF_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_GREENPHIRE-ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_IAF_ICF_PL_Polish_Public | n/a |
| Subject information and informed consent form (for publication) | L1_GA44839_IAF_IT_Italian_Admin Change_1_CL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_IAF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Infant ICF_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Infant-Authorization-Form_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Infant-Health-ICF_GRC_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Infant-Health-ICF_GRC_Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Infant-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main ICF_BE_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main ICF_FR_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main_ICF_Czech Republic_Czech_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main-ICF_BE_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main-ICF_BE_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main-ICF_DE_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main-ICF_GRC_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main-ICF_GRC_Greek_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main-ICF_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main-ICF_PL_Polish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Main-ICF_Sponsor_Statement_BE_English_Public | n/a |
| Subject information and informed consent form (for publication) | L1_GA44839_Optional-Biosample-for-Repository_ICF_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Optional-Greenphire-ICF_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_OptionalFutureResearch-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_PP-Data-Release-ICF_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_PP-Data-Release-ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_PP-Data-Release-ICF_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_PPA_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Pregnancy_ICF_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Pregnancy-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Pregnant-Partner-Authorization-Form_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Pregnant-Partner-ICF_ PL_Polish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Pregnant-Partner-ICF_GRC_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Pregnant-Partner-ICF_GRC_Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Privacy-Addendum-Form_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_Privacy-Third-Parties_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GA44839_ReimbursementVendor-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_GA44839_eCOA Participant Quick Reference Guide_csCZ_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_GA44839_Patient card_FR_French_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_GA44839_Patient facing At Home Stool Collection Instructions_CZ_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_GA44839_Patient-Card_CZE_Czech_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_GA44839_Site facing At Home Stool Collection Instructions_CZ_Czech_Public | 1.0 |
| Summary of results (for publication) | Study GA44839_CTIS Results Summary_05 Feb 2026 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE-DE Redacted 2023-506655-19-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR Redacted 2023-506655-19-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL Redacted 2023-506655-19-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_Redacted 2023-506655-19-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG Redacted 2023-506655-19-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FR Redacted 2023-506655-19-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR Redacted 2023-506655-19-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT Redacted 2023-506655-19-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL Redacted 2023-506655-19-00.pdf | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-de-2023-506655-19-00 EEA redacted | 2(EEA) |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-fr-2023-506655-19-00 EEA redacted | 2(EEA) |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-nl-2023-506655-19-00 EEA redacted | 2(EEA) |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_cz-2023-506655-19-00 EEA redacted | 2(EEA) |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2023-506655-19-00 EEA redacted | 2(EEA) |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-fr-2023-506655-19-00 EEA redacted | 2(EEA) |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_gr-2023-506655-19-00 EEA redacted | 2(EEA) |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2023-506655-19-00 EEA redacted | 2(EEA) |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2023-506655-19-00 EEA redacted | 2(EEA) |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-20 | France | Acceptable 2024-04-22
|
2024-04-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-03 | France | Acceptable 2024-04-22
|
2024-05-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-17 | Acceptable | 2024-07-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-17 | Acceptable | 2024-06-28 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-17 | Acceptable | 2024-06-03 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-17 | France | Acceptable | 2024-06-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-05-17 | Acceptable | 2024-07-22 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-05-17 | Acceptable | 2024-06-10 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-05-17 | Acceptable | 2024-07-30 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-29 | France | Acceptable | 2024-10-29 |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-06 | France | Acceptable 2025-02-14
|
2025-02-14 |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-05-30 | France | Acceptable 2025-07-09
|
2025-07-09 |