Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
669
Countries
15
Sites
146
Immune system diseases
Pivotal Maintenance Sub-Study Cohort 1: To assess the efficacy of duvakitug as maintenance therapy compared with placebo in participants with moderately to severely active CD
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-03-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sanofi-Aventis Recherche & Developpement
External identifiers
- EU CT number
- 2025-521037-86-00
- WHO UTN
- U1111-1314-5471
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacokinetic
Pivotal Maintenance Sub-Study Cohort 1: To assess the efficacy of duvakitug as maintenance therapy compared with placebo in participants with moderately to severely active CD
Secondary objectives 4
- Pivotal Maintenance Sub-Study Cohort 1: To assess the efficacy of duvakitug as maintenance therapy by multiple measures of disease activity in participants with moderately to severely active CD
- Pivotal Maintenance Sub-Study Cohort 1: To evaluate the PK and immunogenicity of duvakitug in participants with moderately to severely active CD
- Pivotal Maintenance Sub-Study Cohort 1: To assess the safety of duvakitug as maintenance therapy compared with placebo in participants with moderately to severely active CD
- Open-Label Extension Sub-Study: To assess the safety of long-term administration of duvakitug in participants with moderately to severely active CD
Conditions and MedDRA coding
Immune system diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10011401 | Crohn´s disease | 100000004856 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-000000-PIP00-00
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
- Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1
- OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
Exclusion criteria 2
- Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
- Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission (CDAI) at Week 40
- Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
- Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission per PRO-2 at Week 40
- Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
Secondary endpoints 19
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40
- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40
- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40
- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40
- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40
- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40
- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at Baseline) at Week 40
- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per CDAI at Week 40 in the subset of participants with clinical remission per CDAI at Week 0 (maintenance of clinical remission per CDAI)
- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per PRO-2 at Week 40 in the subset of participants with clinical remission per PRO-2 at Week 0 (maintenance of clinical remission per PRO-2)
- Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Incidence of CD related hospitalization by Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Serum concentrations of duvakitug measured over time
- Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment- emergent antidrug antibody (ADA) against duvakitug
- Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment- emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment-emergent serious adverse events (TESAEs) and TEAEs leading to permanent study intervention discontinuation
- Open-Label Extension Sub-Study: Incidence of TEAEs, TEAESIs, TESAEs, and TEAEs leading to permanent study intervention discontinuation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12634307 · Product
- Active substance
- Duvakitug
- Substance synonyms
- Human IgG1 lambda monoclonal antibody against TL1A, TEV-48574, Human IgG1 lambda monoclonal antibody against TNFSF15
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 280 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Matched placebo for test product
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
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 82 Avenue Raspail
- City
- Gentilly
- Postcode
- 94250
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Services and operations
Public contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Services and operations
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Fisher Clinical Services UK Limited ORG-100012049
|
Horsham, United Kingdom | Code 14 |
| MARKEN Germany GmbH ORG-100017196
|
Hamburg, Germany | Code 14 |
| ESMS Global Limited ORG-100023149
|
London, United Kingdom | Other |
| Psi CRO Greece ORG-100047165
|
Athens, Greece | Other |
| Teckro Limited ORG-100041454
|
Limerick, Ireland | Other |
| Psi Cro AG ORG-100034251
|
Zug, Switzerland | On site monitoring, Code 12, Other, Code 2, Code 5, Data management |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Code 14, Interactive response technologies (IRT) |
Locations
15 EU/EEA countries · 146 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 9 | 9 |
| Belgium | Authorised, recruitment pending | 4 | 4 |
| Bulgaria | Authorised, recruitment pending | 11 | 9 |
| Czechia | Authorised, recruitment pending | 24 | 8 |
| France | Authorised, recruitment pending | 13 | 13 |
| Germany | Authorised, recruitment pending | 34 | 27 |
| Greece | Authorised, recruitment pending | 3 | 3 |
| Hungary | Authorised, recruitment pending | 8 | 5 |
| Italy | Authorised, recruitment pending | 14 | 13 |
| Lithuania | Authorised, recruitment pending | 2 | 2 |
| Netherlands | Authorised, recruitment pending | 2 | 3 |
| Norway | Authorised, recruitment pending | 2 | 2 |
| Poland | Authorised, recruitment pending | 60 | 38 |
| Slovakia | Authorised, recruitment pending | 10 | 4 |
| Spain | Authorised, recruitment pending | 8 | 6 |
| Rest of world
Serbia, Switzerland, South Africa, Georgia, United Arab Emirates, Chile, Brazil, United Kingdom, Kazakhstan, Taiwan, United States, Moldova, Republic of, China, Argentina, Ukraine, Japan, New Zealand, Australia, Turkey, Israel, Mexico, Canada, Korea, Republic of, Colombia, Saudi Arabia
|
— | 465 | — |
Investigational sites
Medical University Of Vienna
Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Waehringer Guertel 18-20, Alsergrund, Vienna
Universitaetsklinikum Krems
Department of Internal Medicine II, Mitterweg 10, 3500, Krems An Der Donau
Imed19 Betriebs GmbH
Imed19 Private Medical Center, Billrothstrasse 49, Doebling, Vienna
Medical University Of Graz
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Neue Stiftingtalstrasse 6, 8010, Graz
Stadt Wien Wiener Gesundheitsverbund
Hospital Floridsdorf, Department of Internal Medicine, Bruenner Strasse 68, Floridsdorf, Vienna
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department of Internal Medicine I, Muellner Hauptstrasse 48, 5020, Salzburg
Stadt Wien Wiener Gesundheitsverbund
Clinic Ottakring, Department of Internal Medicine IV, Montleartstrasse 37, Ottakring, Vienna
Krankenhaus Der Barmherzigen Brueder St. Veit/Glan
Department of Internal Medicine, Spitalgasse 26, 9300, St. Veit An Der Glan
Johannes Kepler University Linz
Department of Internal Medicine II, Med Campus III, Krankenhausstrasse 9, Linz
Ziekenhuis Oost Limburg
Gastroenterology, Synaps Park 1, 3600, Genk
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Gastroenterology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Vitaz
Gastroenterology, Moerlandstraat 1, 9100, Sint-Niklaas
Centre hospitalier universitaire de Liege
Gastroenterology, Avenue De L'Hopital 1, 4000, Liege
Acibadem City Clinic Tokuda University Hospital EAD
Department of Gastroenterology at Gastroenterology Clinic, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
Diagnostics And Consultation Center Convex Ltd.
N/A, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department of Gastroenterology, Krasno Selo, Bulevard Gen Totleben 21, Sofiya
Multiprofile Hospital For Active Treatment Vita Ltd.
Department of Gastroenterology, Ulitsa Filip Kutev 10, 1407, Sofiya
Medical center Orange Ltd.
N/A, Ulitsa 109 19 Ground Floor, Lyulin 1 District, Sofia
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
First Department of Internal Medicine, Ulitsa Otets Paisiy 72, 5100, Gorna Oryahovitsa
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
Gastroenterology Clinic, Bulevard Tsarigradsko Shose 66a, 1784, Sofia
The medical centre Kanev Ltd.
N/A, Str. Independence No 2, 7002, Ruse
Diagnostic Consultation Center XX-Sofia EOOD
N/A, Ulitsa Gen. Stefan Toshev No. 15-17, 1618, Sofia
Vojenska Nemocnice Brno
Interní oddělení, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Fakultni Nemocnice Brno
Interní gastroenterologická klinika, Jihlavska 340/20, Bohunice, Brno
Hepato-Gastroenterologie HK s.r.o.
N/A, Trida Edvarda Benese 1549/34, 500 12, Hradec Kralove
Fakultni Nemocnice U Sv Anny V Brne
Gastroenterologické a hepatologické oddělení, Pekarska 53, Stare Brno, Brno-Stred
Iscare a.s.
Gastroenterologie - IBD centrum, Ceskomoravska 2510/19, Liben, Prague
PreventaMed s.r.o.
Interní ambulance, Domovina 774/2, 779 00, Olomouc
Axon Clinical s.r.o.
Interní ambulance, Ostrovskeho 253/3, Smichov, Prague 5
Nemocnice Slany
Interní oddělení, Politickych Veznu 576, 274 01, Slany
Centre Hospitalier Universitaire De Lille
Hôpital Claude Huriez, Gastroenterology, Rue Michel Polonowski, 59000, Lille
CHU Besancon
Hôpital Jean Minjoz, Gastroentorology, 3 Boulevard Alexandre Fleming, 25000, Besancon
Centre Hospitalier Universitaire Grenoble Alpes
Hôpital Michallon, Hepato-gastroenterology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire Amiens Picardie
Hôpital Sud, Hepato-gastroenterology, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire De Nantes
Hôpital Hôtel Dieu, Gastroenterology, 1 Place Alexis Ricordeau, 44000, Nantes
Clinique Jules Verne
Gastroenterology, 2 Route De Paris, 44300, Nantes
Centre Hospitalier Regional De Marseille
Hôpital Marseille Nord, Hepato-gastroenterology, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire De Saint Etienne
Hôpital Nord, Gastroenterology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Assistance Publique Hopitaux De Paris
Hôpital Bichat Claude-Bernard, Hepato-gastroenterology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Assistance Publique Hôpitaux de Paris
Henri-Mondor, Gastroenterology, 1 rue Gustave Eiffel, 94000, Créteil
Centre Hospitalier Universitaire De Toulouse
Hôpital Rangueil, Gastroenterology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nice
Hôpital L’Archet, Gastroenterology, 151 Route De Saint Antoine, 06200, Nice
CHRU De Nancy
Hôpitaux de Brabois, Gastroenterology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Eugastro GmbH
Internal Medicine, Gastroenterology, Hepatology, Johannisplatz 1, Zentrum Sudost, Leipzig
Magen-Darm-Zentrum-Remscheid
N/A, Rosenhügelerstr. 2, 42859, Remscheid
Universitaetsklinikum Tuebingen AöR
Internal Medicine I, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Krankenhaus Waldfriede e.V.
N/A, Argentinische Allee 40, Zehlendorf, Berlin
Universitaetsklinikum Erlangen AöR
Department of Internal Medicine 1, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Ulm AöR
Centre for internal Medicine, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsmedizin Goettingen
Department Gastroenterology, gastrointestinal Oncology and Endocrinology, Robert-Koch-Strasse 40, Weende, Goettingen
Philipps-Universitaet Marburg
Gatstroenterology, Endocrinology and Metabolism, Baldingerstrasse, 35043, Marburg
Medical Care Unit Dachau
N/A, Muenchner Str. 64, 85221, Dachau
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Internal medicine, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Wuerzburg AöR
Gastroenterology, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Klinikum Ernst von Bergmann gGmbH
Gastroenterologie, Hepatologie, Infektiologie und Rheumatologie, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
FamiCord AG
Internal medicine and Gastroenterology, Salvador-Allende-Strasse 2-8, Koepenick, Berlin
Staedtisches Klinikum Lueneburg gGmbH
Internal medicine and Gastroenterology, Boegelstrasse 1, Mittelfeld, Lueneburg
Universitaetsklinikum Schleswig-Holstein AöR
Clinic for internal Medicine, Arnold-Heller-Strasse 3, Brunswik, Kiel
Gastroenterologische Gemeinschaftspraxis Minden
N/A, Uferstr. 3, 32423, Minden
Marienkrankenhaus Kassel gGmbH
Gastroenterology, Marburger Strasse 85, Rothenditmold, Kassel
Charite Universitaetsmedizin Berlin KöR
Hepatology and Gastroenterology, Chariteplatz 1, Mitte, Berlin
Berufsausübungsgemeinschaft Dres. Schulze, Schwerdtfeger, Lehmann
N/A, Johannes-Lange-Str. 20, Haus 7, Jerichow
Universitaetsklinikum Regensburg AöR
Department of Internal Medicine I, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
University Medical Center Hamburg-Eppendorf
I. Medical Clinic and Polyclinic, Martinistrasse 52, Eppendorf, Hamburg
Gastroenterologische Gemeinschaftspraxis Herne
Gastroenterology and Hepatology, Wiescherstr. 20, 44623, Herne
Universitaetsklinikum Halle (Saale) AöR
N/A, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
Gesundheit Nord gGmbH Klinikverbund Bremen
Department of Gastroenterology, Hepatology, Endocrinology and Nutrition, St.-Juergen-Strasse 1, Hulsberg, Bremen
Medizinisches Versorgungszentrum fuer spezialaerztliche Versorgung Professor Dr. Friedrichs GmbH
Gastroenterology, Zu Den Rehwiesen 9, Wanheimerort, Duisburg
Universitaetsklinikum Leipzig AöR
Clinic and Polyclinic of Gastroenterology and Rheumatology, Liebigstrasse 20, Zentrum-Suedost, Leipzig
St. Marien Und St. Annastiftskrankenhaus
Internal Medicine and Gastroenterology, Salzburger Strasse 15, Gartenstadt, Ludwigshafen Am Rhein
General University Hospital Of Larissa
Department of Gastroenterology, P. O. Box 1425, 411 10, Larissa
Thoracic General Hospital Of Athens I Sotiria
3rd Academic Department of Internal Medicine, Messogion Avenue 152, 115 27, Athens
University General Hospital Of Heraklion
Gastroenterology Department, Stavrakia And Voutes, 715 00, Heraklion
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Center for Internal Medicine and Infectology, BIC, Knezich Karoly Utca 1, 3300, Eger
VeszLife Kft.
NA, Szofia Utca 2/1, 8200, Veszprem
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department of Gastroenterology, Dozsa Gyorgy Ut 77, 2800, Tatabanya
Geomedical Kft.
NA, Jokai Utca 6, Kerulet, Budapest VI
Obudai Egeszseguegyi Centrum Kft.
NA, Lajos Utca 74-76, 1036, Budapest III
Azienda Socio Sanitaria Territoriale Ovest Milanese
Gastroenterology Department, Via Papa Giovanni Paolo II, 20025, Legnano
Humanitas Mirasole S.p.A.
Operative Unit (UO) Inflammatory Bowel Diseases, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione IRCCS Policlinico San Matteo
S.C. General Medicine I, Viale Camillo Golgi 19, 27100, Pavia
Policlinico San Donato S.p.A.
Department of Gastroenterology, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
S.C. Gastroenterology and Digestive Endoscopy, Viale Luigi Borri N 57, 21100, Varese
Azienda Ospedaliera Ordine Mauriziano Di Torino
Complex Operative Unit of Gastroenterology - largo Turati 62, 10128 Turin, Via Ferdinando Magellano 1, 10128, Turin
San Camillo Forlanini Hospital
Complex Operative Unit of Gastroenterology and Diagnostic Digestive Endoscopy, Circonvallazione Gianicolense 87, 00152, Rome
Azienda Ospedaliera di Padova
Complex Operative Unit Gastroenterology, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliero Universitaria Di Modena
Complex Structure of Gastroenterology, Largo Del Pozzo 71, 41124, Modena
ASST Grande Ospedale Metropolitano Niguarda
Hepatology and Gastroenterology Unit, Piazza Dell'ospedale Maggiore 3, 20162, Milan
ARNAS G. Brotzu
Gastroenterology Unit, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Ospedale San Raffaele S.r.l.
Gastroenterology and Gastrointestinal Endoscopy, Via Olgettina 60, 20132, Milan
ASST Fatebenefratelli Sacco
Digestive System Diseases and Digestive Endoscopy, Via Giovanni Battista Grassi 74, 20157, Milan
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Bendrosios gastroenterologijos sektoriaus, Eiveniu G. 2, Kauno M. Sav., Kaunas
Respublikine Panevezio ligonine VšĮ
Gastroenterologijos skyriaus vedejas, Smelynes G. 25, Panevezio M. Sav., Panevezys
Radboud universitair medisch centrum Stichting
Gastroenterology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Stichting Elisabeth-Tweesteden Ziekenhuis
Gastroenterology & Hepatology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Amsterdam UMC Stichting
Gastroenterology and Hepatology, De Boelelaan 1117, 1081 HV, Amsterdam
Universitetssykehuset Nord-Norge HF
NorTrials Gastrointestinal department, Hansine Hansens Veg 67, 9019, Tromsoe
Akershus University Hospital
Gastrolab B102, Sykehusveien 25, 1474, Loerenskog
Bodyclinic Sp. z o.o. sp.k.
Wielospecjalistyczna Przychodnia Lekarska BodyClinic, Ul. Ulica Jozefa Sierakowskiego 4/u3, 03-712, Warsaw
Globe Badania Kliniczne Sp. z o.o.
N/A, Ul. Janusza Kusocinskiego 3a, 57-300, Klodzko
Ip Clinic Sp. z o.o.
IP Clinic, Ul. Gen. Lucjana Zeligowskiego 3/5, 90-752, Lodz
Osrodek Badan Klinicznych CLINSANTE S. C Ewa Galczak - Nowak Małgorzata Trzaska
N/A, ul. Tytusa Chałubińskiego 6, 85-794, Bydgoszcz
Synexus Polska Sp. z o.o.
Oddział w Poznaniu, Ul. Glogowska 31/33, 60-702, Poznan
EMC Instytut Medyczny S.A.
Prywatna Lecznica "Certus" Szpital Nr 1, Prywatna Lecznica Certus Ambulatoria, Ul. Grunwaldzka 156, 60-309, Poznan
Novamed Robert Koteras
Twoja Przychodnia Opolskie Centrum Medyczne, ul. Kurpiowska 6/2, 45-819, Opole
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.
Topolowa Medicenter, Ul. Topolowa 33/7, 31-506, Cracow
Endoskopia Sp. z o.o.
N/A, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Wsd Medi Clinical Sp. z o.o.
WSD Medi, Aleja Jana Rodowicza Anody 22 Lok U 4, 02-786, Warsaw
H-T.Centrum Medyczne Sp. z o.o. sp.k.
H-T. Centrum Medyczne- Endoterapia, Aleja Bielska 103a, 43-100, Tychy
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia Szczecińskie Centrum Medyczne, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Centrum Medyczne Oporow
N/A, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Gastromed Sp. z o.o.
N/A, Ul. Grudziadzka 11/13-14, 87-100, Torun
Manermed Sp. z o.o.
Centrum Medyczne "MEDIS", Ul. Garbary 5/l4, 85-229, Bydgoszcz
Solumed Sp. z o.o. sp.k.
Solumed Centrum Medyczne, Ul. Jana Henryka Dabrowskiego 77a, 60-529, Poznan
Centrum Medyczne Medyk Sp. z o.o. S.K.
Szpital Centrum Medycznego Medyk, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Synexus Polska Sp. z o.o.
Oddział w Katowicach, Ul. Konckiego 3, 40-040, Katowice
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkuś, Ul. Plowiecka 103, 04-501, Warsaw
Szpital Miejski Sw. Jana Pawla II W Elblagu
Oddział Chorób Wewnętrznych, Ul. Jana Amosa Komenskiego 35, 82-300, Elblag
Centrum Medyczne Med-Gastr Sp. z o.o.
N/A, Ul. Mokra 4, 91-034, Lodz
Zaniewski Bilski Sp. z o.o.
Przychodnia Medicus filia w Olsztynie, Ul. Melchiora Wankowicza 5, 10-684, Olsztyn
Sonomed Sp. z o.o.
Sonomed, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Melita Medical Sp. z o.o.
Centrum Medyczne Melita Medical, Ul. Strzegomska 2-4, 53-611, Wroclaw
Eb Group Sp. z o.o.
Centrum Zdrowia MDM, Ul. Inflancka 4a, 00-189, Warsaw
Nzoz For Med Sp. z o.o.
N/A, Ul. Lwowska 93, 34-100, Wadowice
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.
N/A, Ul. Dluga 10a/21-26, 28-200, Staszow
Etg Zamosc Sp. z o.o.
ETG Zamość, Ul. Gesia 3, 22-400, Zamosc
Allmedica Badania Kliniczne Sp. z o.o. sp.k.
Niepubliczny Zakład Opieki Zdrowotnej Allmedica Badania Kliniczne, Ul. Kowaniec 2a, 34-400, Nowy Targ
Therapia Nova Sp. z o.o.
Therapia Nova, Ul. Ks. Jerzego Popieluszki 19/21 20 I 21, 01-595, Warsaw
EMC Instytut Medyczny S.A.
Penta Hospitals Przychodnie, Wrocław Wejherowska, Building 4, Ul. Wejherowska 28, Wroclaw
Lukmed 2 Sp. z o.o.
ETG Siedlce, Ul. Mlynarska 16 B, 08-110, Siedlce
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie
N/A, Ul. Aleje Raclawickie 23, 20-049, Lublin
Vita Longa Sp. z o.o.
Niepubliczny Zakład Opieki Zdrowotnej "Vita Longa" Sp. z o.o., Ul. Uniczowska 6, 40-748, Katowice
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Centrum medyczne PLEJADY, Ul. Tadeusza Szafrana 5d / U2-U5, 30-363, Cracow
Vistamed & Vertigo Sp. z o.o.
Vistamed, Ul Raclawicka 105 1b, 53-149, Wroclaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej
Oddział Gastroenterologiczny, Ul. Krasnystawska 52, 21-010, Leczna
Synexus Polska Sp. z o.o.
Oddział w Częstochowie, Aleja Najswietszej Maryi Panny 15, 42-202, Czestochowa
Gastro I. s.r.o.
Gastroenterologická ambulancia, Jana Holleho 5898/14, 080 01, Presov
Gastro LM s.r.o.
Gastroenterologická ambulancia, Jurkovicova 7081/18, 080 01, Presov
Cliniq s.r.o.
Gastroenterologické centrum, Bezrucova 5, Stare Mesto, Bratislava
Endomed s.r.o.
Gastroenterologická ambulancia, Americka Trieda 19, Sidlisko Tahanovce, Kosice
Hospital Universitario Juan Ramon Jimenez
Digestive, Ronda Exterior Norte S/n, 21005, Huelva
Hospital Universitario De Cabuenes
Digestive, Calle Prados 395, Cabuenes, Gijon
Clinica Gaias Santiago
Digestive, Rua Do Pintor Xaime Quesada N 2-4, 15702, Santiago De Compostela
Complejo Hospitalario Universitario De Ourense
Digestive, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Universitario 12 De Octubre
Digestive, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Virgen De La Macarena
Digestive, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 230 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1-rdct-protocol-en-2025-521037-86 | 1 |
| Protocol (for publication) | d1-rdct-protocol-gr-GR-2025-521037-86 | 1 |
| Protocol (for publication) | d4-patient facing documents-cd-symptoms-diary-en-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient facing documents-cd-symptoms-diary-es-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient facing documents-cd-symptoms-diary-hu-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptomps-diary-it-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms diary-lt-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms-diary-at-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms-diary-bg-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms-diary-cz_2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms-diary-de-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms-diary-fr-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms-diary-fr-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms-diary-gr-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms-diary-nl-2025-521037-86 | 2 |
| Protocol (for publication) | d4-patient-facing-documents-cd-symptoms-diary-sk_2025-521037-86 | 2 |
| Protocol (for publication) | d4-rdct-patient-facing-documents-copyrighted-en-2025-521037-86 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Materials_Patient Advocacy Fact Sheet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Fact Sheet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Fact Sheet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Fact Sheet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Fact Sheet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Fact Sheet_public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Advocacy Fact Sheet | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Fact Sheet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Fact Sheet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Fact Sheet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Fact Sheet CD | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Fact Sheet CD | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Advocacy Fact Sheet_BE-FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Advocacy Fact Sheet_BE-NL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Leaflet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet CD | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Leaflet_BE-FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Leaflet_BE-NL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Leaflet_public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster CD | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Poster_BE-FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Poster_BE-NL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician referral letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician referral letter_CD_BE-FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Physician referral letter_CD_BE-NL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Translation Certificate | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Patient Advocacy Fact Sheet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Advocacy Fact Sheet | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Advocacy Fact Sheet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Patient Leaflet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Leaflet | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Leaflet | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Leaflet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Poster | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Poster | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Patient Poster_v1_0_04JUL25_DE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Physician Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Physician Referral Letter | 1.9 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Physician Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Physician Referral Letter | 1.0 |
| Subject information and informed consent form (for publication) | L1_centre-specific contact list_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic_EN_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 16-17 years_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adolescent Period 1_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adolescent Period 2_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adolescent_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main adults_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Period 1_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Period 2_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OFR_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Procedures for 16-17 years_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Procedures Parent_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Procedures_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional tests and Future Research_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parent Period 1_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parent Period 2_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parent_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Data Collection_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Follow Up_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Follow Up_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Follow-up_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy FU_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy FU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy FU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_EN_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 years_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR Pregnancy follow-up | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR Pregnancy follow-up | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 16-18 years_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main LAR of the Minor_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parent_BE-FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parent_BE-NL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-NL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE Period only_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE Period_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Assent 16-18 years_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional biopsies_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional biopsies_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional future research | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional future research | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional genetic testing in future research | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional genetic testing in future research | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional genetic testing_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional genetic testing_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional intestinal ultrasound_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional_adults_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional_LAR of the Minor_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pediatric Assent_BE-FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pediatric Assent_BE-NL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PIS_Use of Personal Data_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow up_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy follow-up | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy follow-up | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_Assent 16-18 years_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_BE-FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_BE-NL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_LAR of the Minor_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS Genetic_EN_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS Genetic_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Sponsor statement on the use of ICF model_Redacted | N/A |
| Subject information and informed consent form (for publication) | L2_Other patient information_GP Letter_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other patient information_Participant reimbursement form_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Vendor DPN_redacted | N/A |
| Subject information and informed consent form (for publication) | L2_Patient Card_EN_public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card_HU_public | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Other subject information material_Instructions_placeholder for publication | N/A |
| Synopsis of the protocol (for publication) | D1_lay-protocol-synopsis-nl-NL-2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-bg-BG-2025-521037-86-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-cz-CZ-2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-de-AT_2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-de-BE-2025-521037-86-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-en-2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-es-ES-2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-fr-BE-2025-521037-86-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-fr-FR-2025-521037-86-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-gr-GR-2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-hu-HU-2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-it-IT-2025-521037-86-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-lt-LT-2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-nl-BE-2025-521037-86-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-no-NO-2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pl-PL-2025-521037-86-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-sk-SK-2025-521037-86 | 1 |
| Synopsis of the protocol (for publication) | d1-rdct-scientific-protocol-synopsis-de-AT-2025-521037-86 | 1 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-20 | Austria | Acceptable 2026-02-23
|
2026-02-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-10 | Austria | Acceptable 2026-02-23
|
2026-03-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-11 | Acceptable 2026-02-23
|
2026-03-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-23 | Acceptable | 2026-04-29 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-30 | Acceptable | 2026-05-12 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-30 | Acceptable | 2026-05-08 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-31 | Acceptable | 2026-04-07 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-01 | Acceptable | 2026-05-08 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-04-24 | Acceptable | 2026-05-12 |