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A Study of Afimkibart for Ulcerative Colitis

This study is testing a drug called Afimkibart (also known as RO7790121) for people with moderately to severely active ulcerative colitis (UC). UC is a long-term condition that causes inflammation and ulcers in your digestive tract. Researchers want to see how well Afimkibart works and if it's safe compared to a placebo (an inactive substance). You might be able to join if you are between 16 and 80 years old, weigh at least 40 kg, have a confirmed UC diagnosis, and your UC hasn't responded well to other treatments. The main goal is to see how many participants achieve clinical remission (a significant reduction in symptoms) after 12 weeks. The study plans to enroll about 350 participants, but its current status is unclear.

Study design
This is a Phase III, multicenter, double-blind study, meaning neither you nor your doctor will know if you're receiving Afimkibart or a placebo. It plans to enroll about 350 participants.
What's involved
Participants will receive Afimkibart or placebo through an IV (into a vein) and then by subcutaneous (under the skin) injection.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06588855

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Recruiting
PHASE3Ages 16–80InterventionalTreatment
Hoffmann-La Roche
~350 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:AfimkibartPlacebo

At a glance

Recruiting sites
162 of 200 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Clinical Remission
Measured over At Week 12

Conditions

Moderately to Severely Active Ulcerative Colitis

Explore related trials

Ulcerative Colitis

Where it's being run

200 sites across 69 states
Poland19
China16
Texas13
Florida12
New York7
California6
Ohio6
Portugal6

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: GA45330 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. and Canada)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Confirmed diagnosis of UC
Moderately to severely active UC assessed by 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
Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion

Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
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
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
Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

What this trial measures

  • Percentage of Participants with Clinical RemissionAt Week 12

    Percentage of participants achieving Modified Mayo Score (mMS) \<=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.