drugset / Trial / NCT02843659

Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome

NCT02843659

Phase 2 Terminated 45 enrolled Bristol-Myers Squibb
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.

Timeline

Start
2016-10-18
Primary completion
2017-07-24
Completion
2017-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-986142 Small molecule Oral
Subject lulizumab pegol Monoclonal antibody Subcutaneous

Indications