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

• Status: Completed
• Trial end date: 2017-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Male or female aged between 18 to 70 (included)

• Diagnosed with active systemic lupus erythematosus by a doctor

• Disease must be in patient's joints or on the skin at a minimum

• Taking other medications is allowed but some are excluded

Exclusion Criteria:

• Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis

• Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus