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NCT06588855 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Moderately to Severely Active Ulcerative Colitis, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT06588855: Recruiting Phase 3 study of Moderately to Severely Active Ulcerative Colitis, sponsored by Hoffmann-La Roche.
NCT06588855 is a Phase 3 study of Moderately to Severely Active Ulcerative Colitis that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 350 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06588855, a Phase 3 study of Moderately to Severely Active Ulcerative Colitis, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
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).
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
- Hi Tech and Global Research, LLC - Coral Gables
- The Sister Life Research - Hialeah
- LCC Medical Research Institute, LLC - Miami
- Allied Biomedical Research Institute - Miami
- Ambert Medical Research - Miami
- Gastroenterology Institute of Orlando - Orlando
- Digestive and Liver Center of Florida - Orlando
- Advanced Medical Research Center - Port Orange
- University of South Florida School of Medicine Morsani Center for Advanced Health Care - Tampa
- Guardian Angel Research Center, LLC - Tampa
- Santos Research Center, CORP - Tampa
California
- Om Research LLC - Apple Valley
- Valley View Internal Medicine - Garden Grove
- Gastro Care Associates - Lancaster
- Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education - Newport Beach
- Stanford Medicine Outpatient Center - Redwood City
Arizona
- Mayo Clinic Hospital - Scottsdale
- Arizona Digestive Health, P.C (ADH) - Sun City
Alabama
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan - Dothan
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2024-12-11 |
| Est. Completion | 2029-12-30 |
| Phase | Phase 3 |
What NCT06588855 shows while recruiting
NCT06588855 is an interventional study that assigns participants to a tested intervention. The registered 350 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 (55% 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.
NCT06588855 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06588855 about?
NCT06588855 is a clinical study titled "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". 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).
What is the current status of trial NCT06588855?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2024-12-11. Estimated completion is 2029-12-30.
What conditions does trial NCT06588855 study?
This clinical trial studies the following conditions: Moderately to Severely Active Ulcerative Colitis.
What interventions are being tested in trial NCT06588855?
The interventions under investigation include: Placebo (DRUG), Afimkibart (DRUG).
Who is sponsoring clinical trial NCT06588855?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06588855 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 NCT06588855's enrollment target sits among peer trials
350 1035th of 2000 higher than 956 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
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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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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
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