An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:4/5/2019
Start Date:September 1, 2017
End Date:July 21, 2020
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus

This study will investigate BMS-986165 to assess its effects in patients with systemic lupus
erythematosus (SLE).


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification
criteria for SLE and diagnosed ≥ 24 weeks before the screening visit

- One of the following: antinuclear antibody (ANA) ≥ 1:80 or positive
anti-double-stranded DNA (dsDNA) or positive anti-Smith (Sm)

- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points
and clinical SLEDAI-2K score ≥ 4 points

Exclusion Criteria:

- Subjects with drug-induced SLE, certain other autoimmune diseases, and active, severe
lupus nephritis

- SLE overlap syndromes such as scleroderma and mixed connective tissue disease

- Clinically significant abnormalities on chest x-ray or ECG

- History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
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El Cajon, California 92020
Phone: 16193344764203
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
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Minneapolis, Minnesota 55455
(612) 625-5000
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Seattle, Washington 98104
(206) 543-2100
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Austin, Texas 78731
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Austin, Texas 78745
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Aventura, Florida 33180
Phone: 305-932-4162
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10700 Stancliff Road
Beaumont, Texas 77702
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Brandon, Florida 33511
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Brooklyn, New York 11217
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-6043
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Charlotte, North Carolina 28204
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Chesapeake, Virginia 23320
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Cumberland, Maryland 21502
Phone: 301-724-4337
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Dallas, Texas 75246
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5323 Harry Hines Blvd
Dallas, Texas 75390
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2675 North Decatur Road
Decatur, Georgia 30033
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Freehold, New Jersey 07728
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Hagerstown, Maryland 21740
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3725 East League City Parkway
Houston, Texas 77034
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Indianapolis, Indiana 46250
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Lansing, Michigan 48910
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4202 Collins Road
Lansing, Michigan 48910
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500 Medical Center Boulevard
Lawrenceville, Georgia 30045
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New Haven, Connecticut 6520
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New York, New York 10016
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Palm Desert, California 92260
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Tamarac, Florida 33321
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13801 Bruce B Downs Boulevard
Tampa, Florida 33613
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