Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Moderately to Severely Active Crohn's Disease, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
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)
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 |
What NCT06819878 shows while recruiting
NCT06819878 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 266-participant average among 3 other Moderately to Severely Active Crohn's Disease trials with a reported enrollment target (126% 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.
NCT06819878 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
Similar trials for Moderately to Severely Active Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
RECRUITING · Phase 3
-
Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease
COMPLETED · Phase 3
-
VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00004317 · 600 participants · Phase 4
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
- NCT00209235 · 600 participants · NA
Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments
- NCT01473784 · 600 participants · NA
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
- NCT01866371 · 600 participants
High Resolution Retinal Imaging
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI