Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis

Summary

This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.

Timeline

Start

2019-05-06

Primary completion

2021-05-17

Completion

2021-05-17

Outcome

Outcome not reported

Stopped: “The trial was stopped based on the assessment of clinical data.”

Publications

• D'Haens G, Peyrin-Biroulet L, Marks DJB, Lisi E, Liefaard L, Beaton A, Srinivasan N, Bouma G, Prasad N, Cameron R, Kayali Z, Tarzi R, Hanauer S, Sandborn WJ. A randomised, double-blind, placebo-controlled study of the LAG-3-depleting monoclonal antibody GSK2831781 in patients with active ulcerative colitis. Aliment Pharmacol Ther. 2023 Aug;58(3):283-296. doi: 10.1111/apt.17557. Epub 2023 Jun 16.

Drugs

Indications