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

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

Outcome

Missed primary endpoint

registry analysis (superiority test); Experimental: 12.5mg SC BMS-931699 Weekly vs Placebo Comparator: 0mg SC Weekly BMS-931699; p = 0.9745; Chi-squared NCT02265744 ↗

registry analysis (superiority test); Experimental: 12.5mg SC BMS-931699 Every Other Week vs Placebo Comparator: 0mg SC Weekly BMS-931699; p = 0.6217; Chi-squared NCT02265744 ↗

registry analysis (superiority test); Experimental: 5mg SC Injection BMS-931699 Every Other Week vs Placebo Comparator: 0mg SC Weekly BMS-931699; p = 0.8295; Chi-squared NCT02265744 ↗

registry analysis (superiority test); Experimental: 1.25mg SCBMS-931699 Every Other Week vs Placebo Comparator: 0mg SC Weekly BMS-931699; p = 0.9439; Chi-squared NCT02265744 ↗

Publications

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BMS-931699	Unknown	1.25 mg	Subcutaneous
Subject	BMS-931699	Unknown	5 mg	Subcutaneous
Subject	BMS-931699	Unknown	12.5 mg	Subcutaneous

Indications