NCT06588855Active, not recruitingPhase 3
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 6 Sept 2024
- Start date
- 11 Dec 2024
- Primary completion date
- 29 Oct 2026
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Ulcerative colitis
- NCT number
- NCT06588855
- EU CT number
- 2024-513015-27-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 350
- From 11 Dec 2024 to the primary completion date, 29 Oct 2026
- 186 sites in 31 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Other illness
- Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
- History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
Other
- Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
- Presence of an ostomy or ileoanal pouch
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
Who the study is looking for
- Confirmed diagnosis of UC
- Moderately to severely active UC assessed by mMS
- Bodyweight \>= 40 kilogram (kg)
- Up to date with colorectal cancer (CRC) screening performed according to local standards
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
Age in the registry: 16 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (186)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Britanico Coordinator of this site? Confirm its status | Ciudad Autonoma Bs As | Argentina | Unknown status |
| Instituto Medico CER Coordinator of this site? Confirm its status | Quilmes | Argentina | Unknown status |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Active, not recruiting |
| Klinikum Wels-Grieskirchen GmbH Coordinator of this site? Confirm its status | Wels | Austria | Active, not recruiting |
| Macquarie University Hospital Coordinator of this site? Confirm its status | Macquarie Park | Australia | Unknown status |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Onze-Lieve-Vrouwziekenhuis Coordinator of this site? Confirm its status | Aalst | Belgium | Active, not recruiting |
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Active, not recruiting |
| Algemeen Ziekenhuis Oostende Coordinator of this site? Confirm its status | Ostend | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Medical Centre Futuremeds EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Acibadem City clinic University Hospital EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Newdata Clinical Trials Coordinator of this site? Confirm its status | Aracaju | Brazil | Unknown status |
| CECIP - Centro de Estudos Clínicos do Interior Paulista Coordinator of this site? Confirm its status | Jaú | Brazil | Unknown status |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Centro Paulista de Investigacao Clinica Cepic Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto Lobus Unimed Volta Redonda Coordinator of this site? Confirm its status | Volta Redonda | Brazil | Unknown status |
| Barrie GI Associates Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| LDDI Clinical Trials Inc. Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| London Health Sciences Centre Uni Campus Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CIUSSS de l'Est-de-l'Île-de-Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| TIDHI Innovation Inc. Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Centro de Investigación Clínica UC-CICUC Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Beijing No.6 Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Third Xiangya Hospital Centrel South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Guangzhou First People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Huizhou Central People's Hospital Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| The First Affilliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| The First Affiliate Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| The Affiliated Hospital of Medical College Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Zhongshan Hospital Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Hepato-Gastroenterologie HK, s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Active, not recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| ISCARE a.s. Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Staedtisches Klinikum Lueneburg gGmbH Coordinator of this site? Confirm its status | Lueneburg | Germany | Active, not recruiting |
| Klinikum Ernst von Bergmann gGmbH Coordinator of this site? Confirm its status | Potsdam | Germany | Active, not recruiting |
| Region Nordjylland Coordinator of this site? Confirm its status | Aalborg | Denmark | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Active, not recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Active, not recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Active, not recruiting |
| Clinique Jules Verne Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Nouvelles Cliniques Nimoises Coordinator of this site? Confirm its status | Nimes | France | Active, not recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Active, not recruiting |
| Leicester General Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Bronglais General Hospital Coordinator of this site? Confirm its status | Llanrhystud | United Kingdom | Unknown status |
| King College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Stepping Hill Hospital Coordinator of this site? Confirm its status | Stockport | United Kingdom | Unknown status |
| Klinicki bolnicki centar Sestre milosrdnice Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Active, not recruiting |
| Poliklinika Borzan d.o.o. Coordinator of this site? Confirm its status | Osijek | Croatia | Active, not recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Central Hospital Of Northern Pest Military Hospital Coordinator of this site? Confirm its status | Budapest VI | Hungary | Active, not recruiting |
| Vasutegeszseguegyi Nonprofit Koezhasznu Kft. Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Szekesfehervar | Hungary | Active, not recruiting |
| Vas-Oxy Kft Coordinator of this site? Confirm its status | Szombathely | Hungary | Active, not recruiting |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| SMS Superspeciality Hospital Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| SR Kalla Memorial Gastro & General Hospital Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| MIDAS Multispeciality Hospital Coordinator of this site? Confirm its status | Nagpur (urban) | India | Unknown status |
| Kingsway Hospital Coordinator of this site? Confirm its status | Nagpur (urban) | India | Unknown status |
| Yashoda Hospitals Coordinator of this site? Confirm its status | Secunderabad | India | Unknown status |
| Surat Institute of Digestive Sciences Hospitals Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| Gujarat Gastro and Vascular Hospital Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria Coordinator of this site? Confirm its status | Negrar | Italy | Active, not recruiting |
| Ospedale Isola Tiberina - Gemelli Isola Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| Boca Clinical Trials Mexico S.C. (Cd. Mexico) Coordinator of this site? Confirm its status | Miguel Hidalgo | Mexico | Unknown status |
| FAICIC S. de R.L. de C.V. Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Stichting Elisabeth-TweeSteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Active, not recruiting |
| Gastromed Kralisz Romatowski Stachurska Sp. j. Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Promed P.Lach R.Glowacki Sp. j. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Szpital Miejski Sw. Jana Pawla II w Elblagu Coordinator of this site? Confirm its status | Elblag | Poland | Active, not recruiting |
| Osrodek Badan Klinicznych Bd Research Sp. z o.o. Coordinator of this site? Confirm its status | Ilawa | Poland | Active, not recruiting |
| MZ Badania Slowik Zymla Sp.j. Coordinator of this site? Confirm its status | Knurów | Poland | Active, not recruiting |
| Bonifraterskie Centrum Medyczne sp. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Medrise Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Clinical Research Center Sp z o o Medic R Sp k Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| EMC Instytut Medyczny S.A. Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
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| Sonomed Sp. z o.o. Coordinator of this site? Confirm its status | Szczecin | Poland | Active, not recruiting |
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| Eb Group Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Medon Clinical Research Sp. z o.o. Coordinator of this site? Confirm its status | Warszawa | Poland | Active, not recruiting |
| PlanetMed Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Klinical Investigations Group, LLC Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Active, not recruiting |
| Unidade Local de Saude do Algarve E.P.E. Coordinator of this site? Confirm its status | Faro | Portugal | Active, not recruiting |
| Hospital da Luz, S.A Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Active, not recruiting |
| Unidade Local De Saude De Entre O Douro E Vouga E.P.E. Coordinator of this site? Confirm its status | Santa Maria Da Feira | Portugal | Active, not recruiting |
| Unidade Local De Saude De Viseu Dao-Lafoes E.P.E. Coordinator of this site? Confirm its status | Viseu | Portugal | Active, not recruiting |
| Tvm Med Serv S.R.L. Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| General Hospital - Djordje Joanovic Coordinator of this site? Confirm its status | Zrenjanin | Serbia | Unknown status |
| KM Management spol. s r.o. Coordinator of this site? Confirm its status | Nitra | Slovakia | Completed |
| Fakultna nemocnica s poliklinikou Nove Zamky Coordinator of this site? Confirm its status | Nové Zámky | Slovakia | Completed |
| Accout Center s.r.o. Coordinator of this site? Confirm its status | Šahy | Slovakia | Completed |
| Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Burapha University Hospital Coordinator of this site? Confirm its status | Chon Buri | Thailand | Unknown status |
| Sunpasitthiprasong Hospital Coordinator of this site? Confirm its status | Ubonratchathani | Thailand | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Om Research LLC Coordinator of this site? Confirm its status | Apple Valley | United States | Unknown status |
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| Dayton Gastroenterology, Inc. Coordinator of this site? Confirm its status | Beavercreek | United States | Unknown status |
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| Charlotte Gastroenterology and Hepatology, P.L.L.C Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Gastroenterology Associates of Tidewater Coordinator of this site? Confirm its status | Chesapeake | United States | Unknown status |
| University of Cincinnati Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
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