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

Active Not RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Crohns Disease

Interventions: Afimkibart

Countries: United States, Belgium, France, Poland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (11)

Dothan, Alabama, United States
Hamden, Connecticut, United States
Kissimmee, Florida, United States
Boston, Massachusetts, United States
Chesterfield, Michigan, United States
Roeselare, Belgium
Nantes, France
Neuilly-sur-Seine, France
Vandœuvre-lès-Nancy, France
Szczecin, Poland
Warsaw, Poland