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

ClinicalTrials.gov ID: NCT06819878

Public ClinicalTrials.gov record NCT06819878. 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 May 5, 2026, 7:05 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, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease

Study identification

NCT ID: NCT06819878
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 600 participants

Conditions and interventions

Conditions

Moderately to Severely Active Crohns Disease

Interventions

Afimkibart Drug
Placebo Drug

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: Mar 16, 2025
Primary completion: Dec 30, 2028
Completion: Dec 30, 2033
Last update posted: May 3, 2026

2025 – 2033

United States locations

U.S. sites: 92
U.S. states: 26
U.S. cities: 80

Facility	City	State	ZIP	Site status
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan	Dothan	Alabama	36305	Recruiting
Mayo Clinic Hospital	Phoenix	Arizona	85054	Recruiting
Arizona Digestive Health, P.C (ADH)	Sun City	Arizona	85351	Recruiting
University of Arizona-CATS Research Center	Tucson	Arizona	85724	Recruiting
Valley View Internal Medicine	Garden Grove	California	92845-2006	Recruiting
310 Clinical Research	Inglewood	California	90301	Recruiting
UCSD Medical Center	La Jolla	California	92037-0897	Recruiting
Gastro Care Associates	Lancaster	California	93534	Recruiting
Om Research LLC	Lancaster	California	93534	Recruiting
United Gastroenterologists	Los Alamitos	California	90720	Recruiting
Acclaim Clinical Research, Inc.	San Diego	California	92120	Recruiting
Kaiser Permanente	San Francisco	California	94115	Recruiting
UCSF/Medical Center at Mount Zion	San Francisco	California	94115	Recruiting
Rocky Mountain Gastroenterology	Littleton	Colorado	80120	Recruiting
Peak Gastroenterology Surgery Center	Lone Tree	Colorado	80124	Recruiting
Access Research Institute	Brooksville	Florida	34613	Recruiting
Gastro Florida	Clearwater	Florida	33756	Recruiting
HealthMed Clinical Center Inc.	Coral Gables	Florida	33134	Recruiting
Hi Tech and Global Research, LLC	Coral Gables	Florida	33134	Recruiting
The Sister Life Research	Hialeah	Florida	33013	Recruiting
NeoClinical Research	Hialeah	Florida	33016	Recruiting
Clinical Research of Osceola, LLC	Kissimmee	Florida	34741	Recruiting
Florida Research Institute - Lakewood	Lakewood Rch	Florida	34211	Recruiting
LCC Medical Research Institute, LLC	Miami	Florida	33126	Recruiting
Ambert Medical Research	Miami	Florida	33176	Withdrawn
Orlando Regional Healthcare	Orlando	Florida	32806	Recruiting
Nodal Medical Center Research - NMC	Tampa	Florida	33607	Recruiting
University of South Florida School of Medicine Morsani Center for Advanced Health Care	Tampa	Florida	33612	Recruiting
Guardian Angel Research Center, LLC	Tampa	Florida	33614	Recruiting
Theia Clinical Research Centers, LLC	Temple Terrace	Florida	33617	Recruiting
Cleveland Clinic Florida	Weston	Florida	33331	Recruiting
Florida Medical Clinic - Orlando Health	Zephyrhills	Florida	33542	Recruiting
Digestive Healthcare of Georgia	Atlanta	Georgia	30327	Recruiting
Atlanta Gastroenterology Associates	Atlanta	Georgia	30342	Recruiting
Gastroenterology Associates of Central Georgia	Macon	Georgia	31201	Recruiting
Grand Teton Research Group, PLLC	Idaho Falls	Idaho	83404	Recruiting
Northwestern Memorial Hospital	Chicago	Illinois	60611	Recruiting
Illinois Gastroenterology Group-Glenview powered by GI Alliance	Glenview	Illinois	60026	Recruiting
GI Alliance - Gurnee	Gurnee	Illinois	60031	Recruiting
Indiana University Health University Hospital	Indianapolis	Indiana	46202	Recruiting
Gastroenterology Health Partners, PLLC	New Albany	Indiana	47150	Recruiting
Kansas Gastroenterology, LLC under Clinical Trials Network	Wichita	Kansas	67226	Recruiting
Tri-State Gastroenterology Associates	Crestview Hills	Kentucky	41017-3409	Recruiting
Gastroenterology Health Partners, PLLC	Louisville	Kentucky	40218	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	02115	Recruiting
Boston University	Boston	Massachusetts	02118	Recruiting
Michigan Center of Medical Research	Farmington Hills	Michigan	48334	Recruiting
Gastroenterology Associates and Endoscopy Center of North Mississippi	Oxford	Mississippi	38655	Recruiting
Delta Gastroenterology & Endoscopy Center	Southaven	Mississippi	38671	Recruiting
Las Vegas Clinical Trials, LLC	North Las Vegas	Nevada	89030	Recruiting
Mount Sinai Hospital - IBD Clinical Center	New York	New York	10029	Recruiting
Lenox Hill Hospital	New York	New York	10075	Recruiting
DiGiovanna Inst for Med Ed&Res	North Massapequa	New York	11758	Recruiting
Queens Village Medical Care	Queens Village	New York	11428	Recruiting
Mainstreet - Richmond Hill Clinic	Richmond Hill	New York	11418	Recruiting
Gastroenterology Group Of Rochester, LLP	Rochester	New York	14618	Recruiting
University of Rochester Medical Center	Rochester	New York	14642	Recruiting
Atrium Health, Carolinas Healthcare System	Charlotte	North Carolina	28204	Recruiting
Omega Research North Carolina, LLC	Fuquay-Varina	North Carolina	27526	Recruiting
Monroe Biomedical Research	Monroe	North Carolina	28112	Recruiting
Dayton Gastroenterology, Inc.	Beavercreek	Ohio	45440	Recruiting
Digestive Disease Consultants	Brunswick	Ohio	44212	Recruiting
University of Cincinnati Hospital	Cincinnati	Ohio	45267	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	44195	Recruiting
Ohio Gastroenterology Group	Columbus	Ohio	43202	Recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	43210	Recruiting
Gastro Health- Liberty	Liberty Township	Ohio	45044	Recruiting
Gastro Intestinal Research Institute of Northern Ohio	Westlake	Ohio	44145	Recruiting
Central Sooner Research	Norman	Oklahoma	73071	Recruiting
Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	17033	Recruiting
Frontier Clinical Re search, LLC	Uniontown	Pennsylvania	15401-9069	Recruiting
University Gastroenterology	Providence	Rhode Island	02904	Recruiting
Medical University of South Carolina	Charleston	South Carolina	29425	Recruiting
Gastroenterology Associates	Greenville	South Carolina	29607	Recruiting
Gastro One	Germantown	Tennessee	38138	Recruiting
Quality Medical Research	Nashville	Tennessee	37211	Recruiting
Texas Clinical Research Institute, LLC	Arlington	Texas	76012	Recruiting
Proactive El Paso,LLC	El Paso	Texas	79902	Recruiting
Amel Med LLC	Georgetown	Texas	78628	Recruiting
Cano Medical Center	Harlingen	Texas	78550	Recruiting
TDDC dba GI Alliance Research	Mansfield	Texas	76063	Recruiting
SMS Clinical Research, LLC	Mesquite	Texas	75149	Recruiting
Gastroenterology Research of America, LLC	San Antonio	Texas	78229	Recruiting
GI Alliance - Southlake	Southlake	Texas	76092	Recruiting
Baylor Scott and White Medical Center	Temple	Texas	76508	Recruiting
Tyler Research Institute, LLC	Tyler	Texas	75701	Recruiting
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater	Chesapeake	Virginia	23320	Recruiting
Emeritas Research Group	Lansdowne Town Center	Virginia	20176	Recruiting
Blue Ridge Medical Research - Gastroenterology Associates of Central Virginia	Lynchburg	Virginia	24502	Recruiting
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia	Roanoke	Virginia	24014	Recruiting
Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - Williamsburg	Williamsburg	Virginia	23188	Recruiting
The Vancouver Clinic	Vancouver	Washington	98664	Recruiting

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 270 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06819878, 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 May 3, 2026 · Synced May 5, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06819878 live on ClinicalTrials.gov.

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