Tests afimkibart as an injection for ulcerative colitis
Tests afimkibart, given under the skin, in people with moderate to severe ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis
Key facts
- Where
- Cordova, United StatesSee 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: NCT07846683, who can take part
Where in United States
- Gastro OneCordova, United StatesTaking 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
- NCT07846683EU 2026-526684-37-00
- Record updated
- 26 October 2026
- Original description
The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).Read full original descriptionShow less
A Phase III, Multicenter, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).
Inclusion: Confirmed diagnosis of UC; Moderately to severely active UC assessed by modified Mayo Score (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; Females of childbearing potential must meet protocol criteria for contraception requirements.
Exclusion: Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy; 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; 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.