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

NCT06589986 · tracked via the Priya Life Science UK tracker

Sponsor

Hoffmann-La Roche

Phase

Phase 3

Started

2024-09-17

Last updated

2026-09-14

Condition(s) studied

Moderately to Severely Active Ulcerative Colitis

Investigational drug(s) / intervention(s)

AfimkibartPlacebo

Afimkibart: Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

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

Study 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

Sex

ALL

Min age

16 Years

Max age

80 Years

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

Primary outcome measure(s)

Percentage of Participants with Clinical Remission at Week 12 — At 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.
Percentage of Participants with Clinical Remission at Week 52 — At Week 52
Percentage of participants achieving mMS \<= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. 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.

Trial sites (184)

Facility	City	Region
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan	Dothan	Alabama
Om Research LLC	Lancaster	California
University of California Irvine	Orange	California
Peak Gastroenterology Associates	Colorado Springs	Colorado
Access Research Institute	Brooksville	Florida
Gastro Florida	Clearwater	Florida
Clinical Research of Osceola, LLC	Kissimmee	Florida
Auzmer Research	Lakeland	Florida
Florida Research Institute - Lakewood	Lakewood Rch	Florida
Homestead Associates in Research, Inc.	Miami	Florida
Allied Biomedical Research Institute, Inc	Miami	Florida
Miami Beach Clinical Research Center	Miami Beach	Florida
Theia Clinical Research Centers, LLC	Tampa	Florida
Florida Medical Clinic	Zephyrhills	Florida
Gastroenterology Associates of Central Georgia	Macon	Georgia
Grand Teton Research Group, PLLC	Idaho Falls	Idaho
The University of Chicago	Chicago	Illinois
Indiana University Health University Hospital	Indianapolis	Indiana
Gastroenterology Health Partners, PLLC	New Albany	Indiana
Tri-State Gastroenterology Associates	Crestview Hills	Kentucky
Gastroenterology Health Partners, PLLC	Louisville	Kentucky
Louisiana Research Center - GastroIntestinal Associates	Shreveport	Louisiana
Brigham & Womens Hosp	Boston	Massachusetts
Boston University	Boston	Massachusetts
Allied Gastrointestinal Associates, PA	Flowood	Mississippi
Intercity Gastroenterology	Fresh Meadows	New York
Pioneer Clinical Research NY	New York	New York
Digestive Health Partners, PA	Asheville	North Carolina
Peters Medical Research (PMR), LLC	High Point	North Carolina
Monroe Biomedical Research	Monroe	North Carolina
Cleveland Clinic Foundation	Cleveland	Ohio
Ohio Gastroenterology Group	Columbus	Ohio
Gastro Intestinal Research Institute of Northern Ohio	Westlake	Ohio
University Gastroenterology	Providence	Rhode Island
Medical University of South Carolina (MUSC)	Charleston	South Carolina
Gastro One	Cordova	Tennessee
Gastrointestinal Associates of Northeast Tennessee	Johnson City	Tennessee
The University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
GI Alliance	Garland	Texas
TDDC dba GI Alliance Research	Mansfield	Texas

+ 144 more sites — see the full list on the official registry below.

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 NCT06589986 on ClinicalTrials.gov ↗ ← All trials in the UK