RO7790121 for Crohn's Disease
(SIBERITE-2 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that certain medicines are prohibited, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug RO7790121 for Crohn's Disease?
Research shows that targeting tumor necrosis factor alpha (TNF-alpha), a method used by similar treatments, has been effective in treating Crohn's disease. Additionally, drugs like adalimumab, which also target TNF-alpha, have been successful in inducing and maintaining remission in Crohn's patients.12345
What safety data exists for RO7790121 (risankizumab) in humans?
How is the drug RO7790121 different from other Crohn's disease treatments?
The drug RO7790121 may offer a novel approach for Crohn's disease by potentially targeting different pathways or mechanisms than existing treatments like anti-TNF therapies, which some patients do not respond to. This could involve unique components or a new mechanism of action, such as the gp130-STAT3 signaling axis, which is being explored for patients who do not respond to current treatments.1451011
What is the purpose of this trial?
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for adults with Crohn's Disease who haven't responded well to other treatments. They must weigh at least 40 kg and follow specific contraception rules if they can have children. People can't join if they're pregnant, breastfeeding, planning pregnancy, have certain types of fistulas or bowel issues, a history of some infections or cancers within the last five years, or have used prohibited medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive induction therapy with RO7790121 or placebo intravenously, followed by subcutaneous injections
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- RO7790121
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Chugai Pharmaceutical
Industry Sponsor
Dr. Osamu Okuda
Chugai Pharmaceutical
Chief Executive Officer since 2020
MD from Kyoto University
Dr. Mariko Y. Momoi
Chugai Pharmaceutical
Chief Medical Officer
MD from Jichi Medical University