drugset / Trial / NCT02265744

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

NCT02265744

Phase 2 Completed 730 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start
2014-11-13
Primary completion
2017-10-26
Completion
2017-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject lulizumab pegol Monoclonal antibody 1.25 mg Subcutaneous
Subject lulizumab pegol Monoclonal antibody 5 mg Subcutaneous
Subject lulizumab pegol Monoclonal antibody 12.5 mg Subcutaneous

Indications