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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus

Clinicaltrials.gov identifier NCT03920267

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted October 7, 2020

Study Description

Brief summary:

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 or Disease:Systemic Lupus Erythematosus
  • Intervention/Treatment: Drug: BMS-986165
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 360 participants
  • 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
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: January 2023
  • Estimated Study Completion Date: January 2023
Arms and interventions
Arm Intervention/treatment
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
Outcome Measures
  • Primary Outcome Measures: 1. Number of participants with adverse events (AEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
  • 2. Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
  • 3. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
  • 4. Number of participants with abnormal change from baseline in laboratory measurements over time [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
  • 5. Number of participants with abnormal change from baseline in vital signs over time [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

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

Contacts and Locations
Contacts

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

Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show 136 Study Locations
Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information
  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03920267 History of Changes
  • Other Study ID Numbers: IM011-074, 2018-003471-35
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: October 7, 2020
  • Last Verified: October 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lupus Erythematosus, Systemic