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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

Name: 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 — clinical trial record (NCT06819878)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: SIBERITE-1

StatusRecruiting

PhasePhase 3

SponsorHoffmann-La Roche

Started2025-03-17

View on ClinicalTrials.gov ↗

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).

Amendment history 3 changes detected by DataLookout

2026-07-03

Trial sites expanded: 364 → 372 locations

2026-05-05

Trial sites expanded: 355 → 362 locations

2026-04-03

Trial sites expanded: 344 → 355 locations

Trial Details

NCT Number	NCT06819878
Lead Sponsor	Hoffmann-La Roche Collaborators: Chugai Pharmaceutical
Conditions	Moderately to Severely Active Crohns Disease
Enrollment	600 participants
Start Date	2025-03-17
Primary Completion	2028-12-31 (estimated)
Study Completion	2033-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-20