CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 363 enrolled
Drug / intervention
BMS-986165 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓SLE diagnosed at least 24 weeks before screening visit
  • ✓Meets SLICC (Systemic Lupus International Collaborating Clinics) classification criteria for SLE
  • ✓Positive serology: elevated ANA (≥1:80) OR positive anti-dsDNA OR positive anti-Smith (anti-Sm)
  • ✓SLEDAI-2K score ≥6 points with clinical SLEDAI-2K ≥4 points including joint involvement and/or rash (confirmed by Central Review Services)
Key exclusion· 5
  • ✕Drug-induced SLE
  • ✕Active, severe lupus nephritis
  • ✕SLE overlap syndromes such as scleroderma and mixed connective tissue disease
  • ✕Clinically significant abnormalities on chest X-ray or ECG

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03252587
NCT03252587Phase 2Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Aug 17, 2017·Updated Dec 20, 2022

In Brief

A Phase 2 clinical trial evaluating BMS-986165 and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 363 participants across 192 sites in 17 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesArgentina, Australia, Brazil, Canada, Colombia, Germany, Hungary, Israel, Japan, Mexico, Poland, Romania, Russia, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 17, 2017
Enrollment StartSep 21, 2017
Primary CompletionJun 29, 2021
Study CompletionOct 28, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.9 years ago

Interventions

BMS-986165drug

Specified dose on specified days

Placeboother

Specified dose on specified days