GA45330: AMETRINE-2 Induction therapy with RO7790121 in pts with moderate-severe ulcerative colitis
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 Ulcerative Colitis
IRAS ID
1010415
Contact name
Anthony Lei
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
ISRCTN Number
--
Clinicaltrials.gov Identifier
--
Research summary
The purpose of this study is to assess the efficacy and safety of RO7790121 in patients with moderately to severely active ulcerative colitis (UC). RO7790121 is a fully human immunoglobulin G1 monoclonal antibody (mAb) against tumor necrosis factor-like ligand 1A (TL1A). 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.
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 60% chance of being assigned to the study drug group and a 40% chance of being assigned to the placebo group.
The treatment part of the study will have two phases:
1. 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 Week 10.
2. Open-Label Extension Phase
Once patient completes the induction phase of the study, they will have the opportunity to join this optional 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 three more follow-up visits.During the open-label extension phase of the study, patient will continue to have study visits and receive the study drug treatment via subcutaneous injections approximately every 2−4 weeks until the study drug becomes commercially available in the UK. The study will be running in approximately 25 countries, with 10 people in the UK and 350 people.
The study is sponsored by F. Hoffmann- La Roche.REC name
East of Scotland Research Ethics Service REC 2
REC reference
24/ES/0068
Date of REC Opinion
1 Oct 2024
REC opinion
Further Information Favourable Opinion