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Phase II

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

  • Study HIC#:2000023756
  • Last Updated:02/15/2019

Brief Summary:

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

  • Age18 years - 75 years
  • GenderBoth
  • Start Date02/04/2019
  • End Date07/19/2020

Trial Purpose and Description

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

Eligibility Criteria

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

Principal Investigator

Sub-Investigator

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