Tests afimkibart in adults with moderately to severely active Crohn's disease
Tests afimkibart against placebo in people with moderately to severely active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Chambray Les Tours, Clermont-Ferrand, Creteil Cedex, La Roche Sur Yon Cedex 9, Lille, Limoges Cedex 1, Montpellier Cedex 5, Neuilly-Sur-Seine, Paris, Pierre-Bénite, Saint-Priest-en-Jarez, and Vandoeuvre Les Nancy, FranceSee the 12 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 80 years old?
Source: NCT06819891, who can take part
Where in France
- Centre Hospitalier Regional Universitaire De ToursChambray Les Tours, FranceTaking people
- University Hospital Of Clermont-FerrandClermont-Ferrand, FranceTaking people
- Assistance Publique Hopitaux De ParisCreteil Cedex, FranceTaking people
- Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire de LilleLille, FranceTaking people
- Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Medico Chirurgical Ambroise Pare HartmannNeuilly-Sur-Seine, FranceTaking people
- Hopital Saint LouisParis, FranceTaking people
- Hospices Civils de LyonPierre-Bénite, FranceTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT06819891EU 2024-513054-30-00
- Record updated
- 26 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: 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; 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; 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.