Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Keywords

Systemic Lupus Erythematosus Lupus Erythematosus, Systemic BMS-986165 BMS-986165 Dose 1 oral administration BMS-986165 Dose 2 oral administration BMS-986165 Dose 3 oral administration

Eligibility

For people ages 18-75

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

Locations

  • University of California at Irvine College of Medicine accepting new patients
    Orange California 92868 United States
  • Arthritis and Osteoporosis Medical Center-La Palma withdrawn
    La Palma California 90623 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting Investigator Inquiry Form FDA Safety Alerts and Recalls
ID
NCT03252587
Phase
Phase 2
Study Type
Interventional
Last Updated