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Clinical Trials in the UK / NCT06588855
Recruiting Phase 3

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

NCT06588855 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2024-12-11
Last updated
2026-08-05

Condition(s) studied

Moderately to Severely Active Ulcerative Colitis

Investigational drug(s) / intervention(s)

AfimkibartPlacebo

Afimkibart: Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.

Placebo: Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Study summary

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Eligibility

Sex
ALL
Min age
16 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (200)

FacilityCityRegionStatus
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan Dothan Alabama Recruiting
Mayo Clinic Hospital Scottsdale Arizona Recruiting
Arizona Digestive Health, P.C (ADH) Sun City Arizona Recruiting
Om Research LLC Apple Valley California Recruiting
Valley View Internal Medicine Garden Grove California Recruiting
Gastro Care Associates Lancaster California Recruiting
University of Southern California Los Angeles California Recruiting
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education Newport Beach California Recruiting
Stanford Medicine Outpatient Center Redwood City California Recruiting
Peak Gastroenterology Associates Colorado Springs Colorado Recruiting
Hi Tech and Global Research, LLC Coral Gables Florida Recruiting
The Sister Life Research Hialeah Florida Recruiting
LCC Medical Research Institute, LLC Miami Florida Recruiting
Allied Biomedical Research Institute Miami Florida Recruiting
Ambert Medical Research Miami Florida Withdrawn
Integrity Trials LLC Orlando Florida Recruiting
Digestive and Liver Center of Florida Orlando Florida Recruiting
Advanced Medical Research Center Port Orange Florida Recruiting
University of South Florida School of Medicine Morsani Center for Advanced Health Care Tampa Florida Recruiting
Guardian Angel Research Center, LLC Tampa Florida Recruiting
Santos Research Center, CORP Tampa Florida Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
Randomize Now, LLC Atlanta Georgia Recruiting
Atlanta Gastroenterology Associates Atlanta Georgia Recruiting
Gastroenterology Associates of Central Georgia Macon Georgia Recruiting
Grand Teton Research Group, PLLC Idaho Falls Idaho Recruiting
Illinois Gastroenterology Group-Glenview powered by GI Alliance Glenview Illinois Recruiting
GI Alliance - Gurnee Gurnee Illinois Recruiting
Gastro Health Partners, LLC New Albany Indiana Recruiting
Kansas Gastroenterology, LLC under Clinical Trials Network Wichita Kansas Recruiting
One GI: GHP - Gastroenterology Health Partners Louisville Louisville Kentucky Recruiting
Louisiana Research Center - GastroIntestinal Associates Shreveport Louisiana Recruiting
Allied Gastrointestinal Associates, PA Flowood Mississippi Recruiting
Delta Gastroenterology & Endoscopy Center Southaven Mississippi Recruiting
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center Lebanon New Hampshire Recruiting
Ellipsis Research Group Brooklyn New York Recruiting
NYU Inflammatory Bowel Disease Center New York New York Recruiting
Weill Cornell Medical College New York New York Recruiting
DiGiovanna Inst for Med Ed&Res North Massapequa New York Recruiting
Queens Village Medical Care Queens Village New York Recruiting

+ 160 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06588855 on ClinicalTrials.gov ↗ ← All trials in the UK