Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease
Status:
Withdrawn
Trial end date:
2025-05-26
Target enrollment:
Participant gender:
Summary
The study will include participants with moderate to severe Crohn's disease. The aim is to
evaluate the safety, tolerability, and efficacy of anti-oncostatin M monoclonal antibody
(mAb) GSK2330811. This is a parallel group study with Induction and Maintenance periods.
During Induction, the first 100 participants randomised will receive a 450mg GSK2330811 SC
loading dose followed by 150mg weekly (Q1W), or placebo for 12 weeks. Additional dose-ranging
arms will open after the 100th participant is randomized and in addition to placebo and the
highest dose arms will also include a 300mg subcutaneous (SC) loading dose followed by 150mg
SC every 2 weeks (Q2W) arm, a 300mg loading dose followed by 150mg SC every 4 weeks (Q4W) arm
and a 150mg SC every 8 weeks (Q8W) arm. Participants with a clinical response at Week 12 will
continue into a 40-week blinded maintenance period and will receive either 150mg SC Q2W,
150mg SC Q4W, 150mg SC Q8W or placebo. Participants without a clinical response at Week 12
will be offered up to 40 weeks of open label treatment with GSK2330811. Approximately 560
participants will be screened to randomize 280.