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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
NCT06589986 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06589986
The ClinicalTrials.gov registry entry for NCT06589986 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06589986 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06589986?
The interventions under investigation include: Placebo (DRUG), Afimkibart (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06589986?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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