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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus

In brief

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.

Key facts

Study ID

NCT02265744

Run by

Bristol-Myers Squibb

People needed

730

Starts

2014-11-13

Expected to finish

2017-11-30

Last updated by the study team

2019-10-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
• Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus

Where it is running

• St Jude Hospital Yorba Linda — Fullerton, California, United States
• Valerius Med Group & Res Ctr Of Greater Long Beach, Inc. — Long Beach, California, United States
• Harbor UCLA Medical Center — Torrance, California, United States
• University Of Connecticut Health Center — Farmington, Connecticut, United States
• Local Institution — Trumbull, Connecticut, United States
• Center For Rheumatology, Immunology And Arthritis — Fort Lauderdale, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• Jefrey D. Lieberman, Md., Pc — Decatur, Georgia, United States
• Coeur D'Alene Arthrit Clin — Coeur d'Alene, Idaho, United States
• Heartland Research Associates, Llc — Wichita, Kansas, United States
• Beth Israel Deaconess Med. Center Div. Of Gastroenterology — Boston, Massachusetts, United States
• Physician Research Collaboration, Llc — Lincoln, Nebraska, United States
• Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
• North Shore Lij Health System — Great Neck, New York, United States
• The Feinstein Institute For Medical Research — Manhasset, New York, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Joint and Muscle Medical Care and Research Institute (JMMCRI) — Charlotte, North Carolina, United States
• Pmg Research Of Salisbury — Salisbury, North Carolina, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• East Penn Rheumatology Associates, P.C. — Bethlehem, Pennsylvania, United States
• Allegheny-Singer Research Institute (Asri) — Pittsburgh, Pennsylvania, United States
• Tekton Research Inc — Austin, Texas, United States
• Local Institution — Dallas, Texas, United States
• Arthritis Northwest — Spokane, Washington, United States
• Rheumatology Associates Of North Alabama, P.C. — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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