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NCT06589986 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Moderately to Severely Active Ulcerative Colitis, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06589986: Active Phase 3 study of Moderately to Severely Active Ulcerative Colitis, sponsored by Hoffmann-La Roche.
NCT06589986 is a Phase 3 study of Moderately to Severely Active Ulcerative Colitis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06589986, a Phase 3 study of Moderately to Severely Active Ulcerative Colitis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Afimkibart
Study Locations (20)
Florida
- Access Research Institute - Brooksville
- Gastro Florida - Clearwater
- HealthMed Clinical Center Inc. - Coral Gables
- J&A Clinical Research - Doral
- Clinical Research of Osceola, LLC - Kissimmee
- Auzmer Research - Lakeland
- Florida Research Institute - Lakewood - Lakewood Rch
- Homestead Associates in Research, Inc. - Miami
- Allied Biomedical Research Institute, Inc - Miami
California
- Om Research LLC - Lancaster
- UCLA - Los Angeles
- University of California Irvine - Orange
- Stanford Medicine Outpatient Center - Redwood City
- Acclaim Clinical Research, Inc. - San Diego
- UCSF/Medical Center at Mount Zion - San Francisco
- Amicis Research Center - Santa Clarita
Colorado
- Peak Gastroenterology Associates - Colorado Springs
- Peak Gastroenterology Surgery Center - Lone Tree
Alabama
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan - Dothan
Arizona
- Arizona Digestive Health, P.C (ADH) - Sun City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2031-01-30 |
| Phase | Phase 3 |
What the registry record for NCT06589986 still lists
NCT06589986 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Moderately to Severely Active Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06589986 names 20 study sites across 5 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06589986 about?
NCT06589986 is a clinical study titled "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". 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).
What is the current status of trial NCT06589986?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2024-09-17. Estimated completion is 2031-01-30.
What conditions does trial NCT06589986 study?
This clinical trial studies the following conditions: Moderately to Severely Active Ulcerative Colitis.
What interventions are being tested in trial NCT06589986?
The interventions under investigation include: Placebo (DRUG), Afimkibart (DRUG).
Who is sponsoring clinical trial NCT06589986?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06589986 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06589986's enrollment target sits among peer trials
400 923rd of 2000 higher than 1,039 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
RECRUITING · Phase 3
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A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
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