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An Investigational Study to Evaluate BMS-986165 in Patients 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: NCT03252587
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
This study will investigate BMS-986165 to assess its effects in patients with systemic lupus erythematosus (SLE).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: BMS-986165 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Actual Study Start Date : June 13, 2017
Estimated Primary Completion Date : December 3, 2021
Estimated Study Completion Date : December 3, 2021

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 oral administration Drug: BMS-986165
administered orally
Experimental: BMS-986165 Dose 2 oral administration Drug: BMS-986165
administered orally
Experimental: BMS-986165 Dose 3 oral administration Drug: BMS-986165
administered orally
Placebo Comparator: Placebo oral administration Other: Placebo
administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who meet response criteria for SLE Responder Index [SRI(4)] [ Time Frame: 32 weeks ]

Secondary Outcome Measures :
  1. Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline achieving a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score [ Time Frame: 32 weeks ]
  2. Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [ Time Frame: 32 weeks ]
  3. Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [ Time Frame: 32 weeks ]
  4. Distribution of participants experiencing serious adverse events (SAEs) [ Time Frame: 32 weeks ]
  5. Distribution of participants experiencing adverse events (AEs) [ Time Frame: 32 weeks ]
  6. Distribution of participants experiencing abnormalities in laboratory testing [ Time Frame: 48 weeks ]
  7. Distribution of participants experiencing abnormalities in vital signs [ Time Frame: 48 weeks ]
  8. Distribution of participants experiencing abnormalities in electrocardiograms (ECGs) [ Time Frame: 48 weeks ]
  9. Maximum observed plasma concentration (Cmax) [ Time Frame: 48 weeks ]
  10. Time of maximum observed plasma concentration (Tmax) [ Time Frame: 48 weeks ]
  11. Trough observed plasma concentration (Ctrough) [ Time Frame: 48 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:

  • Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE and diagnosed ≥ 24 weeks before the screening visit
  • One of the following: antinuclear antibody (ANA) ≥ 1:80 or positive anti-double-stranded DNA (dsDNA) or positive anti-Smith (Sm)
  • Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points

Exclusion Criteria:

  • Subjects with drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
  • SLE overlap syndromes such as scleroderma and mixed connective tissue disease
  • Clinically significant abnormalities on chest x-ray or ECG
  • History of any significant drug allergy

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): NCT03252587


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: NCT03252587    
Other Study ID Numbers: IM011-021
2017-001203-79 ( EudraCT Number )
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 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