NCT02265744

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 730 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Lupus

Interventions

Type	Name	Description
DRUG	BMS-931699
DRUG	Placebo matching BMS-931699

Timeline

• Start date: 2014-11-13
• Primary completion: 2017-10-26
• Completion: 2017-11-30
• First posted: 2014-10-16
• Last updated: 2019-10-07
• Results posted: 2019-01-04

Locations

121 sites across 23 countries: United States, Argentina, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, Lebanon, Mexico, Netherlands, Peru, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study