Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
573
Countries
20
Sites
127
Ulcerative Colitis
The objective of this study is to compare the efficacy and safety of risankizumab versus vedolizumab over 48 weeks for the treatment of adult subjects with moderate to severe Ulcerative Colitis who are naïve to targeted therapies.
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 23 Jul 2025 → ongoing
- Decision date (initial)
- 2025-07-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The objective of this study is to compare the efficacy and safety of risankizumab versus vedolizumab over 48 weeks for the treatment of adult subjects with moderate to severe Ulcerative Colitis who are naïve to targeted therapies.
Conditions and MedDRA coding
Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Subject has confirmed diagnosis of Ulcerative Colitis for at least 3 months prior to Baseline.
- Subject has active Ulcerative Colitis with an modified Mayo Score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader)
- Subject has demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids (prednisone or equivalent), and immunomodulators.
Exclusion criteria 3
- Subject with a current diagnosis of Crohn's disease (CD) or Irritable Bowel Disease (IBD)-unclassified or a history of radiation colitis or ischemic colitis.
- Subject has received any targeted therapies (TaTs) for UC, including but not limited to infliximab, etanercept, adalimumab, natalizumab, golimumab, ozanimod, ustekinumab, etrolizumab, vedolizumab, tofacitinib, filgotinib, etrasimod, guselkumab, mirikizumab, upadacitinib, and risankizumab.
- Active systemic infection/Clinically important infection during the last 2 weeks prior to Baseline Visit as assessed by the investigator.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Achievement of endoscopic improvement at Week 48, defined as a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability): superiority of risankizumab vs. vedolizumab.
Secondary endpoints 1
- The achievement of clinical remission per mMS at Week 48, defined as SFS ≤ 1 and not greater than Baseline, RBS = 0, and a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability): non-inferiority of risankizumab vs. vedolizumab test first followed by superiority test.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10369455 · Product
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10391031 · Product
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Entyvio 300 mg powder for concentrate for solution for infusion
PRD1598541 · Product
- Active substance
- Vedolizumab
- Substance synonyms
- MLN0002, PB016
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AG05 — -
- Marketing authorisation
- EU/1/14/923/001
- MA holder
- TAKEDA PHARMA A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Bernhard Dodell
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Bernhard Dodell
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Advarra Inc. ORG-100045827
|
Columbia, United States | Other |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| WCG Clinical Inc. ORL-000011509
|
New Jersey, United States | Other |
Locations
20 EU/EEA countries · 127 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 10 | 5 |
| Bulgaria | Ongoing, recruitment ended | 12 | 6 |
| Croatia | Ongoing, recruitment ended | 10 | 5 |
| Czechia | Ongoing, recruitment ended | 15 | 2 |
| Estonia | Ongoing, recruitment ended | 6 | 3 |
| Finland | Ongoing, recruitment ended | 4 | 2 |
| France | Ongoing, recruitment ended | 10 | 5 |
| Germany | Ongoing, recruitment ended | 44 | 21 |
| Hungary | Ongoing, recruitment ended | 16 | 9 |
| Ireland | Ongoing, recruitment ended | 12 | 6 |
| Italy | Ongoing, recruitment ended | 20 | 10 |
| Latvia | Ongoing, recruitment ended | 6 | 3 |
| Lithuania | Ongoing, recruitment ended | 8 | 4 |
| Netherlands | Ongoing, recruitment ended | 12 | 7 |
| Poland | Ongoing, recruitment ended | 50 | 10 |
| Romania | Ongoing, recruitment ended | 6 | 6 |
| Slovakia | Ongoing, recruitment ended | 12 | 3 |
| Slovenia | Ongoing, recruitment ended | 6 | 3 |
| Spain | Ongoing, recruitment ended | 24 | 12 |
| Sweden | Ongoing, recruitment ended | 10 | 5 |
| Rest of world
Brazil, Canada, Taiwan, Saudi Arabia, Puerto Rico, Mexico, Switzerland, Korea, Republic of, United States, United Kingdom, United Arab Emirates, Israel, China
|
— | 280 | — |
Investigational sites
Medical University Of Vienna
Universitaetsklinik fuer Innere Medizin III, Waehringer Guertel 18-20, Alsergrund, Vienna
Klinikum Wels-Grieskirchen GmbH
Universitaetsklinik fuer Innere Medizin I, Grieskirchner Strasse 42, 4600, Wels
Medical University Of Graz
Universitaetsklinik fuer Innere Medizin, Neue Stiftingtalstrasse 6, 8010, Graz
Ordensklinikum Linz GmbH
Interne IV- Gastroenterologie, Seilerstaette 4, 4010, Linz
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Universitaetsklinik fuer Innere Medizin I, Muellner Hauptstrasse 48, 5020, Salzburg
MBAT-Doverie AD
Department of Gastroenterology, Friedrich Gruenanger 2, 1632, Sofia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Clinic of Gastroenterology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department of Gastroenterology, Bulevard Gen. Stoletov No 67a, 1233, Sofia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Clinic of Gastroenterology, Oborishte Distr., Ul.Byalo More 8, Sofia
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Clinic of Gastroenterology, Zapaden District, Sofia Str 64, Plovdiv
Acibadem City Clinic University Hospital EOOD
Clinic of Gastroenterology, Bulevard Tsarigradsko Shose 66a, 1784, Sofia
Poliklinika Borzan d.o.o.
Gastroenterology, Dubrovacka 12, 31000, Osijek
KBC Zagreb
Gastroenterology and Hepatology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
KBC Split
Gastroenterology, Spinciceva 1, 21000, Split
Specijalna Bolnica Medico
Internal medicine, Agaticeva 8, 51000, Rijeka
Poliklinika Solmed d.o.o.
Gastroenterology, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Nemocnice Ceske Budejovice a.s.
gastroenterology, B. Nemcove 585/54, 370 01, Ceske Budejovice
Hepato-Gastroenterologie HK s.r.o.
gastroenterology, Trida Edvarda Benese 1549/34, 500 12, Hradec Kralove
Sihtasutus Parnu Haigla
Endoscopy department, Ristiku Tn 1, 80010, Parnu Linn
Laane-Tallinna Keskhaigla AS
Endoscopy department, Paldiski Mnt 68, 10617, Pohja-Tallinna Linnaosa
East Tallinn Central Hospital
Center of Gastroenterology, Ravi Tn 18, Kesklinna Linnaosa, Tallinn
Kuopio University Hospital
Department of Medicine, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Turku University Hospital
Gastroenterology department, Kiinamyllynkatu 4-8, 20520, Turku
Centre Hospitalier Universitaire De Nice
Service de Gastro-Entérologie & Nutrition, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Montpellier
Service d'Hépato Gastroentérologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Hopital Saint Antoine
Service Gastroenterologie et Nutrition, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
AP-HP Hopital Henri-Mondor
Service de Gastroentérologie, 1 Rue Gustave Eiffel, 94010, Creteil
Centre Hospitalier Universitaire De Saint Etienne
Service Hepato-Gastroenterologie et Oncologie Digestive, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Gastroenterologische Gemeinschaftspraxis Minden
N/A, Hausberger Str. 2b, 32423, Minden
Universitaetsklinikum Schleswig-Holstein AöR
Klinik fuer Innere Medizin I - Gastroenterologie, Hepatologie, Ernaehrungs- und Altersmedizin, Arnold-Heller-Strasse 3, Brunswik, Kiel
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik II, Marchioninistrasse 15, Hadern, Munich
Technische Universitaet Dresden
Medizinische Klinik 1 und Poliklinik 1, Fetscherstrasse 74, Johannstadt-Nord, Dresden
DRK Kliniken Berlin
Klinik für Innere Medizin, Salvador-Allende-Strasse 1-8, Koepenick, Berlin
Praxis fuer Gastroenterologie
N/A, Kronsforder Allee 69, 23560, Luebeck
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Essen AöR
Klinik fuer Gastroenterologie, Hepatologie und Transplantationsmedizin, Hufelandstrasse 55, Holsterhausen, Essen
Praxisgemeinschaft Jerichow Schulze
N/A, Johannes-Lange-Str. 20, 39319, Jerichow
Eugastro GmbH
N/A, Johannisplatz 1, Zentrum Sudost, Leipzig
Universitaetsklinikum Regensburg AöR
Innere Medizin I, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Krankenhaus Waldfriede e.V.
CED-Studienambulanz, Argentinische Allee 40, Zehlendorf, Berlin
Studiengesellschaft BSF UG (haftungsbeschraenkt)
N/A, Grosse Nikolaistrasse 7, Altstadt, Halle (Saale)
Universitaetsklinikum Ulm AöR
Klinik fuer Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 1 – Gastroenterologie, Pneumologie und Endokrinologie, Ulmenweg 18, Innenstadt, Erlangen
Medizinisches Versorgungszentrum Dachau
N/A, Münchner Strasse 64, 85221, Dachau
Medical Center - University Of Freiburg
Klinik fuer Innere Medizin II - Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Medizinische Klinik 1, Wilhelm-Epstein-Strasse 4, Bockenheim, Frankfurt Am Main
Magen-Darm-Zentrum Remscheid
N/A, Rosenhuegeler Strasse 2, 42859, Remscheid
GSGH Gastroenterologische Studiengesellschaft Herne GbR
N/A, Wiescherstr. 20, 44623, Herne
Goethe University Frankfurt
Medizinische Klinik I, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Semmelweis University
Belgyogyaszati es Hematologiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Clinfan Kft.
-, Pollack Mihaly Utca 50, 7100, Szekszard
Pannonia Maganorvosi Centrum Kft.
-, Pannonia Utca 35-37, 1136, Budapest XIII
Obudai Egeszseguegyi Centrum Kft.
-, Lajos Utca 74-76, 1036, Budapest III
University Of Debrecen
Gasztroenterologiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
Central Hospital Of Northern Pest Military Hospital
Gasztroenterológiai Osztály, Podmaniczky Utca 109, 1062, Budapest VI
Semmelweis University
Belgyogyaszati és Onkologiai Klinika, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
University Of Szeged
Szent-Gyorgyi Albert Klinikai Kozpont, Belgyogyaszati Klinika, Kalvaria Sugarut 57, 6725, Szeged
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Gasztroenterologiai es Belgyogyaszati Osztaly, Markusovszky Str. 5, 9700, Szombathely
Connolly Hospital
Department of Gastroenterology, Mill Road, D15 X40D, Dublin 15
Portiuncula University Hospital
Department of Gastroenterology, Balliansloe, H53 T971, Galway
Regional Hospital Mullingar
Department of Gastroenterology, Longford Road, N91 NA43, Mullingar
St Vincent's University Hospital
Department of Gastroenterology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Our Lady Of Lourdes Hospital
Department of Gastroenterology, Windmill Road, A92 VW28, Drogheda
Beaumont Hospital
Hepatology Unit, Beaumont Road, Beaumont, Dublin 9
Azienda Ospedaliero-Universitaria Di Cagliari
Gastroenterologia, Strada Statale 554 N. 1, 09042, Monserrato
Azienda Ospedaliero Universitaria Pisana
Stabilimento di Cisanello - UO Gastroenterologia, Via Roma 67, 56126, Pisa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UOC Gastroenterologia ed Endoscopia, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
SSD per le Malattie Infiammatorie Croniche Intestinali, Via Pietro Albertoni 15, 40138, Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
CEMAD - Centro Malattie Apparato Digerente, Largo Francesco Vito 1, 00168, Rome
Humanitas Mirasole S.p.A.
UO Gastroenterologia ed Endoscopia Digestiva, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Universitaria Federico II Di Napoli
Divisione di Gastroenterologia, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliera di Padova
UOC di Gastroenterologia, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UOC Gastroenterologia ed Epatologia, Via Del Vespro 129, 90127, Palermo
Ospedale San Raffaele S.r.l.
Unità di Gastroenterologia ed Endoscopia Digestiva, Via Olgettina 60, 20132, Milan
Pauls Stradins Clinical University Hospital
Center of Gastroenterology Hepatology and Nutrition, Pilsonu Iela 13, 1002, Riga
Digestive Diseases Centre Gastro SIA
Gastroenterology Department, Gailezera Iela 1, 1079, Riga
Liepajas Regionala Slimnica SIA
Gastroenterology Department, Slimnicas Iela 25, 3414, Liepaja
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Santaros Clinics, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Gastroenterology Department, Eiveniu G. 2, Kauno M. Sav., Kaunas
Respublikine Panevezio ligonine VšĮ
Gastroenterology Department, Smelynes G. 25, Panevezio M. Sav., Panevezys
Inlita - Santara CTC
N/A, Santariskiu str. 5, LT-08406, Vilnius
Albert Schweitzer Ziekenhuis
MDL, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Radboud universitair medisch centrum Stichting
MDL, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Amsterdam UMC Stichting
MDL, De Boelelaan 1117, 1081 HV, Amsterdam
Elisabeth-TweeSteden Ziekenhuis
MDL, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Stichting OLVG
MDL, Oosterpark 9, 1091 AC, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
MDL, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Sint Franciscus Vlietland Groep Stichting
MDL, Kleiweg 500, 3045 PM, Rotterdam
EMC Instytut Medyczny S.A.
NA, Building 4, Ul. Wejherowska 28, Wroclaw
Centrum Medyczne Lukamed Sp. z o.o.
NA, Ul. Mickiewicza 39, 89-600, Chojnice
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
NA, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Eb Group Sp. z o.o.
NA, Ul. Inflancka 4a, 00-189, Warsaw
Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Małgorzata Trzaska
NA, Ul. Chałubińskiego 6, 85-794, Bydgoszcz
Rivermed Sp. z o.o.
NA, Ul. 28 Czerwca 1956 R. Nr 382/u4, 61-441, Poznan
Wsd Medi Clinical Sp. z o.o.
NA, Aleja Jana Rodowicza Anody 22 Lok U 4, 02-786, Warsaw
Twoja Przychodnia Opolskie Centrum Medyczne
NA, ul. Kurpiowska 6/2, 45-819, Opole
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Gastroenterologii i Chorob Wewnetrznych, Ul. Woloska 137, 02-507, Warsaw
Promed P.Lach R.Glowacki Sp. j.
NA, Ul. Olszanska 5g, 31-513, Cracow
Gastro Med S.R.L.
Gastroenterology, Strada Moldovei Nr. 3, 400380, Cluj-Napoca
Memorial Healthcare International S.r.l.
Gastroenterology, Soseaua Ionescu-Sisesti Gheorghe Nr. 8A, 013823, Bucharest
Spitalul Clinic Colentina Bucuresti
Gastroenterology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Institutul Clinic Fundeni
Gastroenterology, Soseaua Fundeni 258, 022328, Bucharest
Asociatia Oncohelp
Gastroenterology, Strada Porumbescu Ciprian 59, 300239, Timisoara
Monza-Ares S.R.L.
Gastroenterology, Strada Bulandra Tony Actor Nr. 27 Sectorul 2, 021967, Bucharest
KM Management spol. s r.o.
gastroenterology, Hodzova 408/46, 949 01, Nitra
Endomed s.r.o.
gastroenterology, Americka Trieda 19, Sidlisko Tahanovce, Kosice
F D Roosevelt University General Hospital Of Banska Bystrica
gastroenterology, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
SPLOSNA BOLNISNICA DR. FRANCA DERGANCA Nova Gorica
Gastroenterology Department, Ulica Padlih Borcev 13/a, 5290, Sempeter Pri Gorici
Splosna Bolnisnica Celje
Department of Intestinal Diseases, Oblakova Ulica 5, 3000, Celje
University Medical Center Ljubljana
Department of Gastroenterology, Zaloska Cesta 7, 1000, Ljubljana
Hospital Universitario Puerta De Hierro De Majadahonda
Gastroenterología, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Clinic De Barcelona
Gastroenterología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Cabueñes
Gastroenterología, Calle Los Prados 395, 33203, Gijón
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Gastroenterología, Carrer Del Doctor Joan Soler 1-3, 08243, Manresa
Hospital Universitario Dr Peset Aleixandre
Gastroenterología, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Complexo Hospitalario Universitario De Pontevedra
Gastroenterología, Calle Mourente S/n, 36164, Pontevedra
El Hospital Universitario De Gran Canaria Dr. Negrin
Gastroenterología, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Fundacion Alcorcon
Gastroenterología, Calle Budapest 1, 28922, Alcorcon
Complexo Hospitalario Universitario De Santiago
Gastroenterología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital General De Granollers
Gastroenterología, Calle De Francesc Ribas 1, 08402, Granollers
Hospital Universitario Virgen De La Macarena
Gastroenterología, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital General Universitario De Valencia
Gastroenterología, Avenida Del Tres Cruces 2, 46014, Valencia
Karolinska University Hospital
Magtarmmottagningen forskning, Eugeniavagen 3, 171 64, Solna
Region Oerebro Laen
Gastrosektionen, Sodra Grev Rosengatan, 701 85, Orebro
Sjukhusen I Vaester-Vaestra Goetalandsregionen
Medicinkliniken, Sodra Ringgatan 30, 441 33, Alingsas
Region Oestergoetland
Mag-tarmmedicinska kliniken, Universitetssjukhuset I, 58185, Linkoping
Danderyds Sjukhus AB
Gastromottagningen, Morbygardsvagen 88, 182 88, Danderyd
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 |
|---|---|---|---|---|---|
| Austria | 2025-07-23 | 2025-09-30 | 2026-03-19 | ||
| Bulgaria | 2025-07-31 | 2025-09-15 | 2026-04-28 | ||
| Croatia | 2025-07-30 | 2025-09-02 | 2026-03-19 | ||
| Czechia | 2025-12-08 | 2025-12-17 | 2026-03-19 | ||
| Estonia | 2025-09-05 | 2025-10-09 | 2026-03-19 | ||
| Finland | 2025-09-22 | 2025-11-18 | 2026-03-26 | ||
| France | 2025-11-28 | 2026-02-03 | 2026-04-21 | ||
| Germany | 2025-08-04 | 2025-09-03 | 2026-04-13 | ||
| Hungary | 2025-08-15 | 2025-09-10 | 2026-04-28 | ||
| Ireland | 2025-08-15 | 2025-10-21 | 2026-03-19 | ||
| Italy | 2025-09-15 | 2025-10-29 | 2026-04-21 | ||
| Latvia | 2025-09-15 | 2026-01-06 | 2026-03-19 | ||
| Lithuania | 2025-08-07 | 2025-09-03 | 2026-03-19 | ||
| Netherlands | 2025-08-25 | 2025-09-23 | 2026-03-19 | ||
| Poland | 2025-08-08 | 2025-08-11 | 2026-04-28 | ||
| Romania | 2025-11-27 | 2025-12-02 | 2026-03-19 | ||
| Slovakia | 2025-11-27 | 2025-12-02 | 2026-03-31 | ||
| Slovenia | 2025-08-04 | 2025-08-29 | 2026-03-30 | ||
| Spain | 2025-07-31 | 2025-08-12 | 2026-03-19 | ||
| Sweden | 2025-09-12 | 2025-09-25 | 2026-04-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 133 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m25540-protocol-redacted | V2.1-EU |
| Protocol (for publication) | D4_Patient facing documents-Placeholder_SK | 1 |
| Protocol (for publication) | D4_Patient facing documents-Public | 1 |
| Recruitment arrangements (for publication) | K1 M25-540 CZ Recruitment and ICF Procedures | 2.0 |
| Recruitment arrangements (for publication) | K1 M25-540 FI Recruitment and ICF Procedures_public | 3.0 |
| Recruitment arrangements (for publication) | K1 M25-540 FR Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1 M25-540 HU Recruitment and ICF Procedures Public | 2.0 |
| Recruitment arrangements (for publication) | K1 M25-540 IE Recruitment and ICF Procedures Public | 2 |
| Recruitment arrangements (for publication) | K1 M25-540 PL Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | K1 M25-540 SE Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | K1 M25-540 SK Recruitment and ICF Procedures | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540 BG Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540 ES Recruitment and ICF Procedures_public | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540 HR Physician Referral Letter | 1 |
| Recruitment arrangements (for publication) | K1_M25-540 HR Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540 IT Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540 NL Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540 RO Recruitment and ICF Procedures | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540 SI Recruitment and ICF Procedures | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540_AT_DarmPlus Video Script_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_M25-540_AT_Recruitment and ICF Procedures_public | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540_DE_Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540_EE_Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_M25-540_LT_Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-540_LV_Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K2 M25-540 CZ Participant Brochure Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M25-540 CZ Participant Flyer Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M25-540 CZ Participant Poster Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M25-540 DE Participant Brochure German_Public | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 DE Participant Flyer German_Public | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 DE Participant Poster German_Public | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 ES Participant Brochure_public | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 ES Participant Flyer_Public | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 ES Participant Poster_Public | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 FR Participant Brochure French | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 IE Participant Brochure PUBLIC | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 IE Participant Flyer PUBLIC | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 IE Participant Poster PUBLIC | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 SE Participant brochure_Public | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 SE Recruitment material Ad Orebro_public | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 SE Recruitment material Letter Orebro_public | 1 |
| Recruitment arrangements (for publication) | K2 M25-540 SK Participant Brochure Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M25-540 SK Participant Flyer Public | 1.0 |
| Recruitment arrangements (for publication) | K2 M25-540 SK Participant Poster Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M25-40 BG Participant Flyer Bulgarian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M25-540 BG Participant Brochure Bulgarian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M25-540 LT Participant Brochure Lithuanian_Public | 1 |
| Recruitment arrangements (for publication) | K2_M25-540 RO Participant Brochure_Public | 01 |
| Recruitment arrangements (for publication) | K2_M25-540 RO Participant Flyer_Public | 01 |
| Recruitment arrangements (for publication) | K2_M25-540 SI Participant Brochure | 01 |
| Recruitment arrangements (for publication) | K2_M25-540 SI Participant Flyer | 01 |
| Recruitment arrangements (for publication) | K2_M25-540 SI Participant Poster | 01 |
| Recruitment arrangements (for publication) | K2_M25-540_AT_ Dr-to-Patient Letter_MS | 1.0 |
| Recruitment arrangements (for publication) | K2_M25-540_AT_Participant Brochure_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M25-540_AT_Participant Flyer_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 IE ICF Continued Treatment PUBLIC | 2 |
| Subject information and informed consent form (for publication) | L1 M25-540 CZ Confidentiality and data protection Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-540 CZ ICF Main Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 CZ ICF Optional Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-540 CZ ICF PTE Addendum Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 ES CTE ICF_Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-540 FI ICF ContinuedTreatmentExtension_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 FI Main ICF_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1 M25-540 FR Addendum Main ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 FR Main ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 FR Optional research ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 FR Pregnant Participant ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1 M25-540 HU Main ICF Public redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 HU PGen OptGen and Biomarker ICF Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 HU PGen OptGen and Biomarker PIS Public redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 IE ICF Main Public Redacted | 3 |
| Subject information and informed consent form (for publication) | L1 M25-540 PL ICF Addendum for Treatment Continuation_Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-540 PL ICF Main_Public Redacted | 4 |
| Subject information and informed consent form (for publication) | L1 M25-540 PL ICF Optional_Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-540 PL ICF Pregnancy_Public | 2 |
| Subject information and informed consent form (for publication) | L1 M25-540 SE ICF Primary Treatment Extension (PTE) | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 SE Main ICF_Public Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 SK Confidentiality and data protection | 1 |
| Subject information and informed consent form (for publication) | L1 M25-540 SK ICF Main Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-540 SK ICF Optional | 1 |
| Subject information and informed consent form (for publication) | L1 M25-540 SK ICF PTE Addendum | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 BG ICF Combined Bulgarian_Public redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_M25-540 BG ICF Combined English_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 BG ICF Combined English_Track changes | 1.1 to 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 ES ICF Main_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 ES ICF Optional_public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M25-540 HR ICF Main_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 HR ICF Optional_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 HR ICF Pregnant Subject_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M25-540 IT ICF Combined_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 IT Pregnancy_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 IT PTE_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 NL ICF Main_Public Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_M25-540 RO ICF Main English_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 RO ICF Main Romanian_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 RO ICF PTE Addendum English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 RO ICF PTE Addendum Romanian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 SI ICF Continued Treatment Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540 SI Main ICF Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_ AT_ICF Main_public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_AT_Blank document_ICF site contact details_public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_AT_ICF PTE_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_DE ICF Pregnancy_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_DE_ICF Main_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_EE_ICF Addendum_Estonian_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_M25-540_EE_ICF Addendum_Russian_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_M25-540_EE_ICF Main_Estonian_Public | 3.2 |
| Subject information and informed consent form (for publication) | L1_M25-540_EE_ICF Main_Russian_Public | 3.2 |
| Subject information and informed consent form (for publication) | L1_M25-540_HR_ICF Addendum_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_LT_ICF Addendum_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_LT_ICF Main_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_LT_ICF Optional_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_LV_ICF Addendum_Latvian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_LV_ICF Addendum_Russian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_LV_ICF Main_Latvian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M25-540_LV_ICF Main_Russian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2 M25-540 HU EU-CTR blank document Subject Participation Card Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-vedolizumab | 1 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol lay synopsis-CZ | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol lay synopsis-EN | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol lay synopsis-FR | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol lay synopsis-NL | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol lay synopsis-RO | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol lay synopsis-SE | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol lay synopsis-SK | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol synopsis-bulgarian_Public | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol synopsis-DE-AT_Public | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol synopsis-es-spanish_Public | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol synopsis-hu-hungarian_Public | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol synopsis-it-italian_Public | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol synopsis-lt-lithuanian_Public | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol synopsis-pl-polish_Public | 2 |
| Synopsis of the protocol (for publication) | D1_m25540-protocol synopsis-si-slovenian_Public | 2 |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-20 | Poland | Acceptable 2025-07-14
|
2025-07-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-23 | Acceptable 2025-07-14
|
2025-07-23 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-29 | Acceptable 2025-07-14
|
2025-07-29 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-29 | Acceptable | 2025-08-14 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-30 | Acceptable | 2025-09-01 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-01 | Acceptable | 2025-08-22 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-01 | Acceptable | 2025-08-25 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-01 | Acceptable | 2025-11-05 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-08-13 | 2025-10-01 | ||
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2025-08-14 | Acceptable 2025-07-14
|
2025-11-03 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2025-08-19 | Acceptable 2025-07-14
|
2025-11-03 | |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2025-08-19 | Acceptable 2025-07-14
|
2025-11-12 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-19 | Acceptable | 2025-11-10 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-22 | Acceptable | 2025-09-26 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-10-16 | Acceptable | 2026-01-19 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-02-02 | Poland | Acceptable 2026-04-28
|
2026-04-28 |