Purpose

The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE)

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug - Women of childbearing potential (WOCBP) must have a negative urine pregnancy test and must agree to use correctly a highly effective method(s) of contraception for the duration of treatment with study drug

Exclusion Criteria

  • Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason - Evidence of active tuberculosis (TB) Other protocol defined inclusion/exclusion criteria could apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants who successfully complete the protocol-required treatment period of the Phase 2 SLE study (NCT03252587) will be offered the opportunity to continue study
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BMS-986165 Dose 1
  • Drug: BMS-986165
    Administered orally
Experimental
BMS-986165 Dose 2
  • Drug: BMS-986165
    Administered orally
Experimental
BMS-986165 Dose 3
  • Drug: BMS-986165
    Administered orally

Recruiting Locations

University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama 35233-1913
Contact:
Walter Chatham, Site 0077
205-975-4016

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
please email
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.