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Clinical Trials in Poland / NCT06589986
Active, not recruiting Phase 3

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 Poland 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)

Afimkibart →Placebo

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
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 — 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)

FacilityCityRegionStatus
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.

More Hoffmann-La Roche trials in Poland

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia Recruiting
An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A Recruiting
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 Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease Active, not recruiting

Other trials for the same condition

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 Active, not recruiting
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 Poland