Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease

Running, not enrolling · Phase 2

Conditions studied: Crohns Disease

In brief

This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.

Key facts

Study ID

NCT05910528

Run by

Hoffmann-La Roche

People needed

21

Starts

2023-07-24

Expected to finish

2026-12-31

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read
• Elevated very soft or liquid stool frequency and/or abdominal pain
• Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy

You may not qualify if…

• Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
• Short gut syndrome
• Presence of an ostomy or ileoanal pouch
• Bowel resection or diversion with \~6-months

Where it is running

• Digestive Health Specialists — Dothan, Alabama, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• I.H.S Health Northwell Health — Kissimmee, Florida, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Clinical Research Institute of Michigan — Chesterfield, Michigan, United States
• AZ Delta — Roeselare, Belgium
• CHU de Nantes — Nantes, France
• Institut des MICI, Clinique Ambroise Paré — Neuilly-sur-Seine, France
• CHRU de Nancy Brabois — Vandœuvre-lès-Nancy, France
• Twoja Przychodnia-Szczecinskie Centrum Medyczne — Szczecin, Poland
• WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland

Full record on ClinicalTrials.gov

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