MedTrace Logo

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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-03-19

No results posted yet for this 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).

Conditions

  • Moderately to Severely Active Ulcerative Colitis

Interventions

DRUG

Afimkibart

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

DRUG

Placebo

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2027-01-30
Completion
2031-01-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Croatia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Serbia
  • Slovakia
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06589986 on ClinicalTrials.gov