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A Study to Assess the Effectiveness and Safety of RO7790121 for Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis
EU CTIS ID: 2024-513015-27-00
What this study is testing
To evaluate the efficacy of afimkibart compared with placebo in inducing clinical remission
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 to ≤ 80 years at the time of signing Informed Consent Form, with bodyweight ≥ 40 kg.
- Confirmed UC diagnosis, active UC with moderately to severely active disease confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy)
- Moderately to severely active UC by modified Mayo Score of 5 to 9, including an endoscopic score of 2 or 3
- Screening for colorectal cancer (CRC) for all participants (performed according to local standards)
- Inadequate response, loss of response, and/or intolerance to prior conventional therapy (aminosalicylates, corticosteroids and/or immunomodulators) while being naïve to advanced therapy (biologics or targeted small molecules, e.g., Approved anti-tumor necrosis factor [TNF], Approved anti-interleukin [IL]-12/IL-23, Approved anti-integrin, Approved sphinsosine-1-phosphate [S1P] receptor modulators, Approved JAK inhibitors, etc.) OR inadequate response, loss of response, and/or intolerance to prior advanced therapy
You likely can't join if
- Severe UC as evidenced by any of the following: – Hospitalization for the treatment of UC ≤ 4 weeks prior to randomization or, in the physician's judgement, is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) during the study - Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months) of toxic megacolon, or bowel perforation. - Prior extensive colonic resection, subtotal, or total colectomy, or planned surgery for UC during the study
- Current diagnosis of Crohn's disease (CD), abdominal / intrabdominal/ perianal fistula and / or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
- Presence of an ostomy or ileoanal pouch
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Any major surgery within 6 weeks prior to screening or a major surgery planned during the study.
- Known exposure to anti-TL1A (afimkibart/RO7790121 [RVT-3101]/PF-06480605) or any type of anti-TL1A therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Israel
- Brazil
- United States
- Argentina
- China
- India
- Mexico
- United Kingdom
- Thailand
- Canada
- Taiwan
- Serbia
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Israel; Brazil; United States; Argentina; China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.