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

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 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).

Key facts

Study ID

NCT06819878

Run by

Hoffmann-La Roche

People needed

600

Starts

2025-03-17

Expected to finish

2033-12-31

Last updated by the study team

2026-07-22

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
• 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, definite low-grade or high-grade colonic dysplasia
• 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

• Mayo Clinic Hospital — Phoenix, Arizona, United States (enrolling)
• Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan — Dothan, Alabama, United States (enrolling)
• University of Arizona-CATS Research Center — Tucson, Arizona, United States (enrolling)
• Valley View Internal Medicine — Garden Grove, California, United States (enrolling)
• Arizona Digestive Health, P.C (ADH) — Sun City, Arizona, United States (enrolling)
• UCSD Medical Center — La Jolla, California, United States (enrolling)
• Gastro Care Associates — Lancaster, California, United States (enrolling)
• Om Research LLC — Lancaster, California, United States (enrolling)
• United Gastroenterologists — Los Alamitos, California, United States (enrolling)
• Acclaim Clinical Research, Inc. — San Diego, California, United States (enrolling)
• 310 Clinical Research — Inglewood, California, United States (enrolling)
• UCSF/Medical Center at Mount Zion — San Francisco, California, United States (enrolling)
• Rocky Mountain Gastroenterology — Littleton, Colorado, United States (enrolling)
• Peak Gastroenterology Surgery Center — Lone Tree, Colorado, United States (enrolling)
• Access Research Institute — Brooksville, Florida, United States (enrolling)
• Gastro Florida — Clearwater, Florida, United States (enrolling)
• HealthMed Clinical Center Inc. — Coral Gables, Florida, United States (enrolling)
• Hi Tech and Global Research, LLC — Coral Gables, Florida, United States (enrolling)
• The Sister Life Research — Hialeah, Florida, United States (enrolling)
• NeoClinical Research — Hialeah, Florida, United States (enrolling)
• Clinical Research of Osceola, LLC — Kissimmee, Florida, United States (enrolling)
• Florida Research Institute - Lakewood — Lakewood Rch, Florida, United States (enrolling)
• LCC Medical Research Institute, LLC — Miami, Florida, United States (enrolling)
• Kaiser Permanente — San Francisco, California, United States (enrolling)
• Orlando Regional Healthcare — Orlando, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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