A Phase II, Multicenter Induction Study With An Active Treatment Extension To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Vixarelimab In Patients With Moderate To Severe Ulcerative Colitis (MOONGLOW)
Research summary
This is a Phase II, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics of vixarelimab compared with placebo in patients with active moderate to severe UC, including 1) patients who have demonstrated inadequate response to, loss of response to, or intolerance to prior advanced therapy which includes biologics and targeted small molecules (advanced failures), and 2) patients who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional therapies (corticosteroids and/or immunosuppressants) but have not failed advanced therapy (conventional failures). The study consists of a screening period of up to 35 days, a 48-week treatment period, and a safety follow-up period for 10 weeks following the final dose of study treatment. The induction period (Weeks 012) will test the induction of clinical remission. After completion of the induction period, all patients, irrespective of clinical response or remission, will be eligible to continue study treatment during an optional active treatment extension (ATE) period (Weeks 1248). During the ATE period, all patients will receive vixarelimab, including patients who received placebo during the induction period, and the durability of clinical response and remission will be explored. Approximately 210 patients, including advanced failures and conventional failures, will be enrolled across global investigational sites. The number of conventional failures will not exceed 40% of enrolled patients in the study. Randomization will be stratified by previous advanced or conventional therapy failure and baseline modified Mayo Score (mMS) (5-7 or 8-9).
Principal Investigator
Dr Oliver Brain
Contact us
Email: ctf.research@ouh.nhs.uk
IRAS number
1009306