NCT04151225

Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease

A Multicentre, Randomised, Double-blind, Placebo-controlled, Repeat Dose, Dose-ranging Phase 2a/2b Study to Evaluate the Safety, Tolerability and Efficacy of an Anti-oncostatin M Monoclonal Antibody (GSK2330811) in Patients With Moderate to Severe Crohn's Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohns Disease
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	GSK2330811	GSK2330811 will be available as SC injection with a unit dose strength of 150 mg/mL. GSK2330811 will be available in single-use pre-filled syringe.
DRUG	Placebo	Placebo will be available as SC injection of 0.9 percent saline solution. It will be available as single-use pre-filled syringe.

Timeline

• Start date: 2021-04-05
• Primary completion: 2024-04-22
• Completion: 2025-05-26
• First posted: 2019-11-05
• Last updated: 2022-01-14

Regulatory

• FDA-regulated drug study