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
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
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.
Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an optional LTE period
The LTE period will remain blinded but will no longer have a placebo arm:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Boston, Massachusetts 02215, United States
Charlotte, North Carolina 28204, United States
Capital Federal, Buenos Aires 1431, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires 1221, Argentina
Savaldor, Estado de Bahia 40150-150, Brazil
Bogota, Cundinamarca, Colombia
Cona - Ferrara, 44124, Italy
Kitakyushu-shi, Fukuoka 8078555, Japan
Sasebo-shi, Nagasaki 8571195, Japan
Shimotsuke-shi, Tochigi 3290498, Japan
Bunkyo-ku, Tokyo 1138655, Japan
Chuo-ku, Tokyo 1048560, Japan
Itabashi-ku, Tokyo 1738610, Japan
Meguro-ku, Tokyo 1538515, Japan
Shinjuku-Ku, Tokyo 1608582, Japan
Mexico City, Distrito Fededral 11850, Mexico
Guadalajara, Jalisco, Jalisco 44160, Mexico
Mexico City, Mexico City 06700, Mexico
Villahermosa, Tabasco 86190, Mexico
San Luis Potosí City, 78213, Mexico