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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920267
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE March 27, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE March 26, 2019
Estimated Primary Completion Date January 8, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Number of participants with adverse events (AEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
  • Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
  • Number of participants with AEs leading to discontinuation [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus
Official Title  ICMJE A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Drug: BMS-986165
Administered orally
Study Arms  ICMJE
  • Experimental: BMS-986165 Dose 1
    Intervention: Drug: BMS-986165
  • Experimental: BMS-986165 Dose 2
    Intervention: Drug: BMS-986165
  • Experimental: BMS-986165 Dose 3
    Intervention: Drug: BMS-986165
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 8, 2023
Estimated Primary Completion Date January 8, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Colombia,   Germany,   Hungary,   Israel,   Japan,   Korea, Republic of,   Mexico,   Poland,   Romania,   Russian Federation,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920267
Other Study ID Numbers  ICMJE IM011-074
2018-003471-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP