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 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
- Moderately to Severely Active Crohns Disease
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Hoffmann-La Roche
- Enrolment target
- 425
- Started
- 12 May 2025
- Main results due
- 31 December 2028
- Study sites
- 203
- Registry updated
- 28 September 2026
Can you take part?
- Ages 16 years to 80 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Confirmed diagnosis of CD * Moderately to severely active CD * Bodyweight \>= 40 kilogram (kg) * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy * Males and females of childbearing potential must meet protocol criteria for contraception requirements Exclusion Criteria: * Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis * Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum) * Diagnosis of short gut or short bowel syndrome * Presence of an ileostomy, colostomy or ileoanal pouch * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * Presence of abdominal or perianal abscess * Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * Current diagnosis or suspicion of primary sclerosing cholangitis * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * Any past or current evidence of cancer of gastrointestinal tract, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed * History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer * Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening * Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB * Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
What this study is about
In the sponsor’s own words, from the registry.
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 sites(203)
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Recruiting
Sun City Clinical Research
Glendale, Arizona, United States
Recruiting
Om Research LLC
Lancaster, California, United States
Recruiting
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California, United States
Recruiting
Empire Clinical Research
Pomona, California, United States
Withdrawn
Stanford Medicine Outpatient Center
Redwood City, California, United States
Recruiting
Clinical Applications Laboratories, Inc.
San Diego, California, United States
Recruiting
Amicis Research Center
Santa Clarita, California, United States
Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Recruiting
J&A Clinical Research
Doral, Florida, United States
Recruiting
Auzmer Research
Lakeland, Florida, United States
Recruiting
Galenus Group Inc
Lehigh Acres, Florida, United States
Recruiting
Homestead Associates in Research, Inc.
Miami, Florida, United States
Recruiting
Allied Biomedical Research Institute, Inc
Miami, Florida, United States
Recruiting
Rejuvaline Medical Research
Miami, Florida, United States
Recruiting
Miami Beach Clinical Research Center
Miami Beach, Florida, United States
Recruiting
Eminat Research Group
Miramar, Florida, United States
Recruiting
Digestive and Liver Center of Florida
Orlando, Florida, United States
Recruiting
Advanced Medical Research Center
Port Orange, Florida, United States
Recruiting
Santos Research Center, CORP
Tampa, Florida, United States
Recruiting
Cleveland Clinic Florida
Weston, Florida, United States
Recruiting
Morehouse School Of Medicine
Atlanta, Georgia, United States
Recruiting
The University of Chicago
Chicago, Illinois, United States
Recruiting
University of Kansas Medical Center
Kansas City, Kansas, United States
Recruiting
Robley Rex VA Medical Center
Louisville, Kentucky, United States
Recruiting
One GI: GHP - Gastroenterology Health Partners Louisville
Louisville, Kentucky, United States
Recruiting
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Recruiting
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, United States
Recruiting
Mercy Medical Center
Baltimore, Maryland, United States
Recruiting
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Recruiting
University of Massachusetts Memorial Medical Center
North Worcester, Massachusetts, United States
Recruiting
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States
Recruiting
Gastrointestinal Associates Research
Flowood, Mississippi, United States
Recruiting
Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital
Columbia, Missouri, United States
Recruiting
Specialists in Gastroenterology
St Louis, Missouri, United States
Recruiting
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Recruiting
Virtua Crohns and Colitis Center
Moorestown, New Jersey, United States
Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Recruiting
Ellipsis Research Group
Brooklyn, New York, United States
Recruiting
Intercity Gastroenterology
Fresh Meadows, New York, United States
Recruiting
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, United States
Recruiting
James J Peters Veterans Affairs Medical Center
The Bronx, New York, United States
Recruiting
Digestive Disease Medicine of Central New York
Utica, New York, United States
Recruiting
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States
Recruiting
Peters Medical Research (PMR), LLC
High Point, North Carolina, United States
Recruiting
Clinical Inquest Center
Beavercreek, Ohio, United States
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
University Gastroenterology
Providence, Rhode Island, United States
Recruiting
Gastro One
Cordova, Tennessee, United States
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Recruiting
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
Dallas, Texas, United States
Recruiting
GI Alliance - Fort Worth
Fort Worth, Texas, United States
Recruiting
GI Alliance
Garland, Texas, United States
Recruiting
Integrity Advanced Therapeutics PLLC
Houston, Texas, United States
Recruiting
Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
Lubbock, Texas, United States
Recruiting
Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas, United States
Recruiting
University of Texas Health Center at Tyler
Tyler, Texas, United States
Recruiting
TDDC GI Alliance research Webster
Webster, Texas, United States
Recruiting
GI Alliance-Richmond
Richmond, Virginia, United States
Recruiting
Showing 60 of 203 sites — filter to narrow it down. 194 of the 203 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06819891. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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