Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

Lupus Clinical Trial

Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus

Status Completed

Clinical Trial Summary

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

Clinical Trial Description

1. Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an optional LTE period

2. The LTE period will remain blinded but will no longer have a placebo arm:

• Subjects will remain on their originally assigned treatment arm unless they were on placebo

• Subjects initially randomized to placebo arm will be automatically re-randomized into one of the existing active arms at Day 169 (24 weeks) ;

Related Conditions & MeSH terms

• Lupus
• Lupus Erythematosus, Systemic

• NCT number: NCT02265744
• Study type: Interventional
• Source: Bristol-Myers Squibb
• Status: Completed
• Phase: Phase 2
• Start date: November 13, 2014
• Completion date: November 30, 2017