RO7790121 for Crohn's Disease (SIBERITE-1 Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Hoffmann-La Roche

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).

Eligibility Criteria

This trial is for adults with a confirmed diagnosis of moderately to severely active Crohn's Disease who weigh at least 40 kg. They must have tried other treatments without success or couldn't tolerate them. Participants need to follow specific contraception guidelines if they can have children.

Inclusion Criteria

I have been diagnosed with Crohn's disease.

I weigh at least 40 kg.

I have not responded well to at least one standard Crohn's disease treatment.

Participant Groups

The study is testing RO7790121, a potential new treatment for Crohn's Disease. It compares the effects of this drug against a placebo during two phases: induction and maintenance therapy, in a controlled environment where neither the participants nor the researchers know who receives which treatment.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 2: RO7790121Experimental Treatment1 Intervention

Participants will receive RO7790121 IV followed by RO7790121 SC injection.

Group II: Arm 1: RO7790121Experimental Treatment1 Intervention

Participants will receive RO7790121 intravenously (IV) followed by RO7790121 subcutaneous (SC) injection.

Group III: Arm 3: PlaceboPlacebo Group1 Intervention

Participants will receive placebo IV followed by placebo SC.