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Recruiting Phase 3 Interventional

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

ClinicalTrials.gov ID: NCT06819891

Public ClinicalTrials.gov record NCT06819891. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 6:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT06819891
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
425 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
16 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 12, 2025 (Actual)
Primary completion
Dec 31, 2028 (Estimated)
Completion
Apr 30, 2033 (Estimated)
Last update posted
Sep 28, 2026

2025 – 2033

United States locations

U.S. sites
61
U.S. states
26
U.S. cities
58
Facility City State ZIP Site status
Digestive Health Specialists of the Southeast Dothan Alabama 36305 Recruiting
Sun City Clinical Research Glendale Arizona 85304 Recruiting
Om Research LLC Lancaster California 93534 Recruiting
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education Newport Beach California 92663 Recruiting
Empire Clinical Research Pomona California 91767 Withdrawn
Stanford Medicine Outpatient Center Redwood City California 94063 Recruiting
Clinical Applications Laboratories, Inc. San Diego California 92103 Recruiting
Amicis Research Center Santa Clarita California 91355 Recruiting
Peak Gastroenterology Associates Colorado Springs Colorado 80907 Recruiting
J&A Clinical Research Doral Florida 33126 Recruiting
Auzmer Research Lakeland Florida 33813 Recruiting
Galenus Group Inc Lehigh Acres Florida 33936 Recruiting
Homestead Associates in Research, Inc. Miami Florida 33033 Recruiting
Allied Biomedical Research Institute, Inc Miami Florida 33155 Recruiting
Rejuvaline Medical Research Miami Florida 33155 Recruiting
Miami Beach Clinical Research Center Miami Beach Florida 33141 Recruiting
Eminat Research Group Miramar Florida 33027 Recruiting
Digestive and Liver Center of Florida Orlando Florida 32825 Recruiting
Advanced Medical Research Center Port Orange Florida 32127 Recruiting
Santos Research Center, CORP Tampa Florida 33615 Recruiting
Cleveland Clinic Florida Weston Florida 33331 Recruiting
Morehouse School Of Medicine Atlanta Georgia 30310-1495 Recruiting
The University of Chicago Chicago Illinois 60637 Recruiting
University of Kansas Medical Center Kansas City Kansas 66160 Recruiting
Robley Rex VA Medical Center Louisville Kentucky 40206 Recruiting
One GI: GHP - Gastroenterology Health Partners Louisville Louisville Kentucky 40218 Recruiting
Baton Rouge General Medical Center Baton Rouge Louisiana 70809 Recruiting
Louisiana Research Center - GastroIntestinal Associates Shreveport Louisiana 71105 Recruiting
Mercy Medical Center Baltimore Maryland 21202 Recruiting
Chevy Chase Clinical Research Chevy Chase Maryland 20815 Recruiting
University of Massachusetts Memorial Medical Center North Worcester Massachusetts 01655 Recruiting
Gastroenterology Associates of Western Michigan, P.L.C. Wyoming Michigan 49519 Recruiting
Gastrointestinal Associates Research Flowood Mississippi 39232 Recruiting
Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital Columbia Missouri 65201-5275 Recruiting
Specialists in Gastroenterology St Louis Missouri 63141 Recruiting
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center Lebanon New Hampshire 03756 Recruiting
Virtua Crohns and Colitis Center Moorestown New Jersey 08057 Recruiting
Robert Wood Johnson University Hospital New Brunswick New Jersey 08901 Recruiting
Ellipsis Research Group Brooklyn New York 11215 Recruiting
Intercity Gastroenterology Fresh Meadows New York 11366 Recruiting
NYU Langone Long Island Clinical Research Associates Lake Success New York 11042 Recruiting
James J Peters Veterans Affairs Medical Center The Bronx New York 10468 Recruiting
Digestive Disease Medicine of Central New York Utica New York 13502 Recruiting
Charlotte Gastroenterology and Hepatology, P.L.L.C Charlotte North Carolina 28207 Recruiting
Peters Medical Research (PMR), LLC High Point North Carolina 27260 Recruiting
Clinical Inquest Center Beavercreek Ohio 45431 Recruiting
Cleveland Clinic Foundation Cleveland Ohio 44195 Recruiting
University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting
University Gastroenterology Providence Rhode Island 02904 Recruiting
Gastro One Cordova Tennessee 38018 Recruiting
Vanderbilt University Medical Center Nashville Tennessee 37212-1375 Recruiting
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center Dallas Texas 75390-8565 Recruiting
GI Alliance - Fort Worth Fort Worth Texas 76104 Recruiting
GI Alliance Garland Texas 75044 Recruiting
Integrity Advanced Therapeutics PLLC Houston Texas 77090 Recruiting
Texas Digestive Disease Consultants-Lubbock powered by GI Alliance Lubbock Texas 79410 Recruiting
Carta - Clinical Associates In Research Therapeutics Of America;LLC San Antonio Texas 78212 Recruiting
University of Texas Health Center at Tyler Tyler Texas 75708 Recruiting
TDDC GI Alliance research Webster Webster Texas 77598 Recruiting
GI Alliance-Richmond Richmond Virginia 23229 Recruiting
University Physicians and Surgeons Inc, dba Marshall Health Huntington West Virginia 25701 Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 142 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06819891, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 28, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06819891 live on ClinicalTrials.gov.

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