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NCT06819891 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Induction 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
- 425
- Enrollment target
- 20
- Study locations
NCT06819891: Recruiting Phase 3 study of Moderately to Severely Active Crohn's Disease, sponsored by Hoffmann-La Roche.
NCT06819891 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 425 participants, above the 325-participant average among 3 other Moderately to Severely Active Crohn's Disease trials with a reported enrollment target (31% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06819891, 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
- 425 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 (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Primary Outcome
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Afimkibart
Study Locations (20)
Florida
- J&A Clinical Research - Doral
- Homestead Associates in Research, Inc. - Miami
- Allied Biomedical Research Institute, Inc - Miami
- Rejuvaline Medical Research - Miami
- Miami Beach Clinical Research Center - Miami Beach
- Eminat Research Group - Miramar
- Digestive and Liver Center of Florida - Orlando
- Advanced Medical Research Center - Port Orange
- Santos Research Center, CORP - Tampa
California
- Om Research LLC - Lancaster
- Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education - Newport Beach
- Empire Clinical Research - Pomona
- Stanford Medicine Outpatient Center - Redwood City
- Amicis Research Center - Santa Clarita
Louisiana
- Baton Rouge General Medical Center - Baton Rouge
- Louisiana Research Center - GastroIntestinal Associates - Shreveport
Arizona
- Sun City Clinical Research - Glendale
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Illinois
- The University of Chicago - Chicago
Kentucky
- Robley Rex VA Medical Center - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2025-05-12 |
| Est. Completion | 2033-04-30 |
| Phase | Phase 3 |
What NCT06819891 shows while recruiting
NCT06819891 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, above the 325-participant average among 3 other Moderately to Severely Active Crohn's Disease trials with a reported enrollment target (31% higher).
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.
NCT06819891 names 20 study sites across 7 states, led by Florida, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT06819891 about?
NCT06819891 is a clinical study titled "A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease". This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction 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 NCT06819891?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 425 participants. The study started on 2025-05-12. Estimated completion is 2033-04-30.
What conditions does trial NCT06819891 study?
This clinical trial studies the following conditions: Moderately to Severely Active Crohn's Disease.
What interventions are being tested in trial NCT06819891?
The interventions under investigation include: Placebo (DRUG), Afimkibart (DRUG).
Who is sponsoring clinical trial NCT06819891?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06819891 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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