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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 | Clinical Trials | Clareo Health

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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

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 Ulcerative Colitis

NCT06589986•Hoffmann-La Roche

View on ClinicalTrials.gov

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 to severely active ulcerative colitis (UC).

Eligibility

Age

16 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (229)

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan

Dothan, Alabama, United States

Arizona Digestive Health, P.C (ADH)

Sun City, Arizona, United States

Om Research LLC

Lancaster, California, United States

UCLA

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

Stanford Medicine Outpatient Center

Redwood City, California, United States

Acclaim Clinical Research, Inc.

San Diego, California, United States

UCSF/Medical Center at Mount Zion

San Francisco, California, United States

Amicis Research Center

Santa Clarita, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Key Dates

Start Date

September 17, 2024

Primary Completion Date

January 30, 2027

Completion Date

January 30, 2031

Last Updated

March 19, 2026

Enrollment

400

ESTIMATED participants

Conditions

Moderately to Severely Active Ulcerative Colitis

Interventions

Afimkibart

DRUG

Placebo

DRUG