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 now · Phase 3 · Has a placebo group

Conditions studied: Moderately to Severely Active Crohns Disease

In brief

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).

Key facts

Study ID

NCT06819891

Run by

Hoffmann-La Roche

People needed

425

Starts

2025-05-12

Expected to finish

2033-04-30

Last updated by the study team

2026-08-04

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States (enrolling)
• Om Research LLC — Lancaster, California, United States (enrolling)
• Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education — Newport Beach, California, United States (enrolling)
• Sun City Clinical Research — Glendale, Arizona, United States (enrolling)
• Stanford Medicine Outpatient Center — Redwood City, California, United States (enrolling)
• Clinical Applications Laboratories, Inc. — San Diego, California, United States (enrolling)
• Amicis Research Center — Santa Clarita, California, United States (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• J&A Clinical Research — Doral, Florida, United States (enrolling)
• Auzmer Research — Lakeland, Florida, United States (enrolling)
• Galenus Group Inc — Lehigh Acres, Florida, United States (enrolling)
• Homestead Associates in Research, Inc. — Miami, Florida, United States (enrolling)
• Allied Biomedical Research Institute, Inc — Miami, Florida, United States (enrolling)
• Rejuvaline Medical Research — Miami, Florida, United States (enrolling)
• Miami Beach Clinical Research Center — Miami Beach, Florida, United States (enrolling)
• Eminat Research Group — Miramar, Florida, United States (enrolling)
• Digestive and Liver Center of Florida — Orlando, Florida, United States (enrolling)
• Advanced Medical Research Center — Port Orange, Florida, United States (enrolling)
• Santos Research Center, CORP — Tampa, Florida, United States (enrolling)
• Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
• Morehouse School Of Medicine — Atlanta, Georgia, United States (enrolling)
• The University of Chicago — Chicago, Illinois, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Robley Rex VA Medical Center — Louisville, Kentucky, United States (enrolling)
• One GI: GHP - Gastroenterology Health Partners Louisville — Louisville, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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