A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-80
SponsorHoffmann-La Roche

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Afimkibart
  • Placebo

Treatment groups

425 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hoffmann-La Roche

Lead sponsor

Chugai Pharmaceutical

Collaborator