GA45332: SIBERITE2 Induction therapy with RO7790121 in pts with moderate-severe Crohn's Disease
Research type
Research Study
Full title
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy with RO7790121 in Patients with Moderately to Severely Active Crohn's Disease
IRAS ID
1010866
Contact name
Anthony Lei
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
The purpose of this study is to assess the efficacy and safety of RO7790121 in patients with moderately to severely active Crohn's disease (CD). RO7790121 is a fully human immunoglobulin G1 monoclonal antibody (mAb) against tumor necrosis factor-like ligand 1A (TL1A). TL1A plays a central role in the regulation of gut mucosal immunity and participates in immunological and fibrosis pathways involved in inflammatory bowel disease pathogenesis by binding its receptor, death receptor 3.
Therapeutic options have expanded substantially over the past decade, however, a high-unmet medical need remains for treatments with better benefit -risk profiles that attenuate inflammation and clinical sequelae and provide sustained control to improve the long-term prognosis of patients with UC.
In this study, patient will get either the study drug or placebo. A placebo looks like a drug but has no active ingredient.
Potential participants will undergo screening tests, and if deemed eligible to take part in the study, will be randomised to a treatment group; there will be a 3 out of 5 chance of being assigned to the study drug group.
The treatment part of the study will have two phases:
Induction Phase
During the induction phase of the study, patient will receive treatment via infusion on the first day of the study, then 2 weeks later, and then every 4 weeks until W10.
Open-Label Extension Phase
Once patient completes the induction phase of the study, they will have the opportunity to join the optional open-label extension phase of the study. In this phase, all participants will receive the study drug (including participants who previously were given placebo).
If a participant decides not to take part in the open-label extension phase of the study, they will be asked to return for two more follow-up visits.
The study will be running in approximately 40 countries, with 4 people in the UK and 425 people.
The study is sponsored by F. Hoffmann- La Roche.REC name
East of Scotland Research Ethics Service REC 2
REC reference
24/ES/0086
Date of REC Opinion
10 Dec 2024
REC opinion
Further Information Favourable Opinion