Testing afimkibart for 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 and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Herlev, DenmarkSee the site
- 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: NCT06819878, who can take part
Where in Denmark
- Region HovedstadenHerlev, DenmarkTaking 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
- NCT06819878EU 2024-513053-69-00
- Record updated
- 16 October 2026
- Original description
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance 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, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance 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, definite low-grade or high-grade colonic dysplasia; 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; Current diagnosis or suspicion of primary sclerosing cholangitis; Pregnancy or breastfeeding, or intention of becoming pregnant during the study.