NCT03893565

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

A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	GSK2831781 - Double Blind Phase	GSK2831781 will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization).
DRUG	Placebo	Placebo (commercial saline solution) will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization).
DRUG	GSK2831781 - Open Label phase	GSK2831781 will be administered intravenously in the open label induction phase and subcutaneously in the open label ETP.

Timeline

• Start date: 2019-05-06
• Primary completion: 2021-05-17
• Completion: 2021-05-17
• First posted: 2019-03-28
• Last updated: 2022-04-27
• Results posted: 2022-04-27

Locations

61 sites across 15 countries: United States, Bulgaria, Czechia, Estonia, France, India, Japan, Netherlands, Poland, Russia, Serbia, Slovakia, South Africa, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study