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NCT06819878 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study of Moderately to Severely Active Crohn's Disease, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT06819878 is a Phase 3 study of Moderately to Severely Active Crohn's Disease that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 600 participants, above the 266-participant average among 3 other Moderately to Severely Active Crohn's Disease trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT06819878, a Phase 3 study of Moderately to Severely Active Crohn's Disease, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 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 induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Afimkibart
Study Locations (20)
California
- Valley View Internal Medicine - Garden Grove
- 310 Clinical Research - Inglewood
- UCSD Medical Center - La Jolla
- Gastro Care Associates - Lancaster
- Om Research LLC - Lancaster
- United Gastroenterologists - Los Alamitos
- Acclaim Clinical Research, Inc. - San Diego
- Kaiser Permanente - San Francisco
- UCSF/Medical Center at Mount Zion - San Francisco
Florida
- Access Research Institute - Brooksville
- Gastro Florida - Clearwater
- HealthMed Clinical Center Inc. - Coral Gables
- Hi Tech and Global Research, LLC - Coral Gables
- The Sister Life Research - Hialeah
Arizona
- Mayo Clinic Hospital - Phoenix
- Arizona Digestive Health, P.C (ADH) - Sun City
- University of Arizona-CATS Research Center - Tucson
Colorado
- Rocky Mountain Gastroenterology - Littleton
- Peak Gastroenterology Surgery Center - Lone Tree
Alabama
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan - Dothan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-03-17 |
| Est. Completion | 2033-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06819878
The ClinicalTrials.gov registry entry for NCT06819878 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 266-participant average among 3 other Moderately to Severely Active Crohn's Disease trials with a reported enrollment target (126% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Moderately to Severely Active Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06819878 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06819878 about?
NCT06819878 is a clinical study titled "A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease". This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
What is the current status of trial NCT06819878?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2025-03-17. Estimated completion is 2033-12-31.
What conditions does trial NCT06819878 study?
This clinical trial studies the following conditions: Moderately to Severely Active Crohn's Disease.
What interventions are being tested in trial NCT06819878?
The interventions under investigation include: Placebo (DRUG), Afimkibart (DRUG).
Who is sponsoring clinical trial NCT06819878?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06819878 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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