Status:
RECRUITING
A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Chugai Pharmaceutical
Conditions:
Moderately to Severely Active Ulcerative Colitis
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief Summary
This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately...
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
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06589986
Start Date
September 17 2024
End Date
December 30 2029
Last Update
December 18 2025
Active Locations (312)
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1
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Dothan, Alabama, United States, 36305
2
Sun City Clinical Research
Glendale, Arizona, United States, 85304
3
Arizona Digestive Health, P.C (ADH)
Sun City, Arizona, United States, 85351
4
University of Arizona-CATS Research Center
Tucson, Arizona, United States, 85724