NCT06819891RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
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 Crohn's Disease
Source: ClinicalTrials.gov · Last updated 26 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 (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 425 (estimated)
- First submitted
- 6 Feb 2025
- Start date
- 12 May 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Crohn's disease
- NCT number
- NCT06819891
- EU CT number
- 2024-513054-30-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 425
- From 12 May 2025 to the primary completion date, 31 Dec 2028
- 231 sites in 27 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
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Other illness
- Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
- Diagnosis of short gut or short bowel syndrome
- Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings
- Any past or current evidence of cancer of gastrointestinal tract, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
- History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
Other
- Presence of an ileostomy, colostomy or ileoanal pouch
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Who the study is looking for
- Confirmed diagnosis of CD
- Moderately to severely active CD
- Bodyweight \>= 40 kilogram (kg)
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD 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 (231)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Medico CER Coordinator of this site? Confirm its status | Quilmes | Argentina | Recruiting |
| CICE 9 de Julio Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Klinikum Wels-Grieskirchen GmbH Coordinator of this site? Confirm its status | Wels | Austria | Recruiting |
| Lyell McEwin Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Footscray Hospital Coordinator of this site? Confirm its status | Footscray | Australia | Recruiting |
| Coral Sea Clinical Research Institute Coordinator of this site? Confirm its status | Mackay | Australia | Withdrawn |
| Macquarie University Hospital Coordinator of this site? Confirm its status | Macquarie Park | Australia | Recruiting |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Sydney Adventist Hospital Coordinator of this site? Confirm its status | Wahroonga | Australia | Recruiting |
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| AZ Sint-Lucas & Volkskliniek Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Coordinator of this site? Confirm its status | Panagyurishte | Bulgaria | Recruiting |
| Medical Centre Futuremeds EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Newdata Clinical Trials Coordinator of this site? Confirm its status | Aracaju | Brazil | Recruiting |
| CECIP - Centro de Estudos Clínicos do Interior Paulista Coordinator of this site? Confirm its status | Jaú | Brazil | Recruiting |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital de Base de Sao Jose do Rio Preto Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Recruiting |
| Hospital Sirio Libanes Coordinator of this site? Confirm its status | São Paulo | Brazil | Withdrawn |
| Instituto Lobus Unimed Volta Redonda Coordinator of this site? Confirm its status | Volta Redonda | Brazil | Recruiting |
| Barrie GI Associates Coordinator of this site? Confirm its status | Barrie | Canada | Recruiting |
| GNRR Digestive Clinics and Research Center Inc. Coordinator of this site? Confirm its status | Brampton | Canada | Recruiting |
| London Health Sciences Centre Uni Campus Coordinator of this site? Confirm its status | London | Canada | Withdrawn |
| LDDI Clinical Trials Inc. Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Toronto Immune and Digestive Health Institute Coordinator of this site? Confirm its status | North YORK | Canada | Recruiting |
| Medicina de Precisión - Celerity Coordinator of this site? Confirm its status | Las Condes | Chile | Recruiting |
| Medwal Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Centro de Investigación Clínica UC-CICUC Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Beijing Union Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| First Affiliated Hospital Of Gannan Medical University Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Zhujiang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangzhou First People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Hainan General Hospital Coordinator of this site? Confirm its status | Haikou | China | Recruiting |
| Huai'an First People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
| Huizhou First Hospital Coordinator of this site? Confirm its status | Huizhou | China | Recruiting |
| Jinhua Municipal Central Hospital Coordinator of this site? Confirm its status | Jinhua | China | Recruiting |
| The First Affilliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
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| Hebei Medical University - The Second Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
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| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Recruiting |
| Clinica Colsanitas S.A. - Sede Clinica Reina Sofia Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
| Clínica de la Mujer Coordinator of this site? Confirm its status | Bogotá | Colombia | Withdrawn |
| Hospital Universitario San Ignacio Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
| Oncomédica S.A. Coordinator of this site? Confirm its status | Montería | Colombia | Recruiting |
| Fundacion Cardiovascular de Colombia - KM 7 Autopista Coordinator of this site? Confirm its status | Piedecuesta | Colombia | Recruiting |
| Hepato-Gastroenterologie HK, s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Gastroenterologie s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
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| Gastroenterologische Spezialpraxis - Berlin-Karlshorst Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Klinikum Ernst von Bergmann gGmbH Coordinator of this site? Confirm its status | Potsdam | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Hospital Universitario Fundación Alcorcón Coordinator of this site? Confirm its status | Alcorcón | Spain | Recruiting |
| Hospital Universitario de Fuenlabrada Coordinator of this site? Confirm its status | Fuenlabrada | Spain | Recruiting |
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| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Recruiting |
| Centre Hospitalier Departemental Vendee Coordinator of this site? Confirm its status | La Roche Sur Yon Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Hospitalier Et Universitaire De Limoges Coordinator of this site? Confirm its status | Limoges Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Centre Medico Chirurgical Ambroise Pare Hartmann Coordinator of this site? Confirm its status | Neuilly-Sur-Seine | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Recruiting |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Fairfield General Hospital Coordinator of this site? Confirm its status | Bury | United Kingdom | Recruiting |
| Bronglais General Hospital Coordinator of this site? Confirm its status | Llanrhystud | United Kingdom | Recruiting |
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Victoria Infirmary Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Stepping Hill Hospital Coordinator of this site? Confirm its status | Stockport | United Kingdom | Active, not recruiting |
| KBC Zagreb Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Recruiting |
| Poliklinika Borzan d.o.o. Coordinator of this site? Confirm its status | Osijek | Croatia | Recruiting |
| Klinička bolnica Dubrava Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Endomedix Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Geomedical Kft. Coordinator of this site? Confirm its status | Budapest VI | Hungary | Recruiting |
| Central Hospital Of Northern Pest Military Hospital Coordinator of this site? Confirm its status | Budapest VI | Hungary | Recruiting |
| Vas-Oxy Kft Coordinator of this site? Confirm its status | Szombathely | Hungary | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| AIG Hospitals Coordinator of this site? Confirm its status | Gachibowli | India | Recruiting |
| SR Kalla Memorial Gastro & General Hospital Coordinator of this site? Confirm its status | Jaipur | India | Recruiting |
| SMS Superspeciality Hospital Coordinator of this site? Confirm its status | Jaipur | India | Recruiting |
| Amrita institute of Medical Sciences Coordinator of this site? Confirm its status | Kochi | India | Recruiting |
| Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital Coordinator of this site? Confirm its status | Kolkata | India | Recruiting |
| Kurnool Medical College Coordinator of this site? Confirm its status | Kurnool | India | Recruiting |
| MIDAS Multispeciality Hospital Coordinator of this site? Confirm its status | Nagpur (urban) | India | Recruiting |
| All India Institute of Medical Sciences(AIIMS) Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
| Shree Giriraj Multispeciality Hospital Coordinator of this site? Confirm its status | Rajkot | India | Withdrawn |
| Gandhi Hospital Coordinator of this site? Confirm its status | Secunderabad | India | Recruiting |
| Yashoda Hospitals Coordinator of this site? Confirm its status | Secunderabad | India | Recruiting |
| Surat Institute of Digestive Sciences Hospitals Coordinator of this site? Confirm its status | Surat | India | Recruiting |
| Gujarat Gastro and Vascular Hospital Coordinator of this site? Confirm its status | Surat | India | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Azienda Sanitaria Locale Matera Coordinator of this site? Confirm its status | Matera | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria Coordinator of this site? Confirm its status | Negrar | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Policlinico San Donato S.p.A. Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Recruiting |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan-si | South Korea | Recruiting |
| Yeungnam University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Chosun University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Hanyang University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Gastromed Kralisz Romatowski Stachurska Sp. j. Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Centrum Medyczne Medis Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| R57 Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Promed P.Lach R.Glowacki Sp. j. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Szpital Miejski Sw. Jana Pawla II w Elblagu Coordinator of this site? Confirm its status | Elblag | Poland | Recruiting |
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| Tvm Med Serv S.R.L. Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Not yet recruiting |
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| Digestive and Liver Center of Florida Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Empire Clinical Research Coordinator of this site? Confirm its status | Pomona | United States | Withdrawn |
| Advanced Medical Research Center Coordinator of this site? Confirm its status | Port Orange | United States | Recruiting |
| University Gastroenterology Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| Stanford Medicine Outpatient Center Coordinator of this site? Confirm its status | Redwood City | United States | Recruiting |
| GI Alliance Richmond Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Carta - Clinical Associates in Research Therapeutics of America, LLC Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Clinical Applications Laboratories, Inc. Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Amicis Research Center Coordinator of this site? Confirm its status | Santa Clarita | United States | Recruiting |
| Virginia Mason Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Louisiana Research Center - GastroIntestinal Associates Coordinator of this site? Confirm its status | Shreveport | United States | Recruiting |
| Specialists in Gastroenterology Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Washington Gastroenterology Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| Santos Research Center, CORP Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| James J. Peters Veterans Affairs Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Tyler Research Institute, LLC Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| University of Texas Health Center at Tyler Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| Digestive Disease Medicine Of Central New York Coordinator of this site? Confirm its status | Utica | United States | Recruiting |
| TDDC GI Alliance research Webster Coordinator of this site? Confirm its status | Webster | United States | Recruiting |
| Cleveland Clinic Florida Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
| Gastroenterology Associates of Western Michigan, P.L.C. Coordinator of this site? Confirm its status | Wyoming | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.