Ireland
--:--IST
Active, not 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 Poland tracker
Phase
Phase 3
Started
2024-12-11
Last updated
2026-10-02

Condition(s) studied

Moderately to Severely Active Ulcerative Colitis

Investigational drug(s) / intervention(s)

Afimkibart →Placebo

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)

  • Percentage of Participants with Clinical Remission — 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.

Trial sites (168)

FacilityCityRegionStatus
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan Dothan Alabama
Mayo Clinic Hospital Scottsdale Arizona
Arizona Digestive Health, P.C (ADH) Sun City Arizona
Om Research LLC Apple Valley California
Valley View Internal Medicine Garden Grove California
Gastro Care Associates Lancaster California
Stanford Medicine Outpatient Center Redwood City California
Peak Gastroenterology Associates Colorado Springs Colorado
Hi Tech and Global Research, LLC Coral Gables Florida
The Sister Life Research Hialeah Florida
LCC Medical Research Institute, LLC Miami Florida
Allied Biomedical Research Institute Miami Florida
Integrity Trials LLC Orlando Florida
Digestive and Liver Center of Florida Orlando Florida
Advanced Medical Research Center Port Orange Florida
University of South Florida School of Medicine Morsani Center for Advanced Health Care Tampa Florida
Guardian Angel Research Center, LLC Tampa Florida
Santos Research Center, CORP Tampa Florida
Cleveland Clinic Florida Weston Florida
Randomize Now, LLC Atlanta Georgia
Atlanta Gastroenterology Associates Atlanta Georgia
Gastroenterology Associates of Central Georgia Macon Georgia
Illinois Gastroenterology Group-Glenview powered by GI Alliance Glenview Illinois
GI Alliance - Gurnee Gurnee Illinois
Gastro Health Partners, LLC New Albany Indiana
Kansas Gastroenterology, LLC under Clinical Trials Network Wichita Kansas
One GI: GHP - Gastroenterology Health Partners Louisville Louisville Kentucky
Louisiana Research Center - GastroIntestinal Associates Shreveport Louisiana
Allied Gastrointestinal Associates, PA Flowood Mississippi
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center Lebanon New Hampshire
Ellipsis Research Group Brooklyn New York
NYU Inflammatory Bowel Disease Center New York New York
Weill Cornell Medical College New York New York
DiGiovanna Inst for Med Ed&Res North Massapequa New York
Queens Village Medical Care Queens Village New York
Gastroenterology Group Of Rochester, LLP Rochester New York
Charlotte Gastroenterology and Hepatology, P.L.L.C Charlotte North Carolina
Omega Research North Carolina, LLC Fuquay-Varina North Carolina
Peters Medical Research (PMR), LLC High Point North Carolina
Dayton Gastroenterology, Inc. Beavercreek Ohio

+ 128 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 NCT06588855 on ClinicalTrials.gov ↗ ← All trials in Poland