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

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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

Study Description
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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 Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: BMS-986165 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 26, 2019
Estimated Primary Completion Date : January 8, 2023
Estimated Study Completion Date : January 8, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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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
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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
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Ages Eligible for Study:   18 Years 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920267


Contacts
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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
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03920267    
Other Study ID Numbers: IM011-074
2018-003471-35 ( EudraCT Number )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
BMS-986165
 Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action