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An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT03252587
Recruitment Status : Active, not recruiting
First Posted : August 17, 2017
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 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 : September 21, 2017
Actual Primary Completion Date : June 29, 2021
Estimated Study Completion Date : November 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1 oral administration Drug: BMS-986165
Specified dose on specified days

Experimental: BMS-986165 Dose 2 oral administration Drug: BMS-986165
Specified dose on specified days

Experimental: BMS-986165 Dose 3 oral administration Drug: BMS-986165
Specified dose on specified days

Placebo Comparator: Placebo oral administration Other: Placebo
Specified dose on specified days




Primary Outcome Measures :
  1. Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [ Time Frame: At Week 32 ]

Secondary Outcome Measures :
  1. Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [ Time Frame: At Week 48 ]
  2. Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [ Time Frame: At Week 48 ]
  3. Number of participants who achieve Lupus Low Disease Activity State (LLDAS) [ Time Frame: At Week 48 ]
  4. 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: At Week 48 ]
  5. Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [ Time Frame: At Week 48 ]
  6. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 56 weeks ]
  7. Incidence of adverse events (AEs) [ Time Frame: Up to 52 weeks ]
  8. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 56 weeks ]
  9. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 56 weeks ]
  10. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 56 weeks ]
  11. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 56 weeks ]
  12. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 56 weeks ]
  13. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 56 weeks ]
  14. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 56 weeks ]
  15. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [ Time Frame: Up to 52 weeks ]
  16. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 48 weeks ]
  17. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 48 weeks ]
  18. Trough observed plasma concentration (Ctrough) [ Time Frame: Up to 48 weeks ]
  19. Change in mean and median interferon-regulated gene (IRG) expression levels [ Time Frame: Up to 52 weeks ]
  20. Change in mean complement (C3, C4) and anti-double-stranded DNA (dsDNA) levels [ Time Frame: Up to 52 weeks ]
  21. Assess the effect of BMS-986165 on measures of global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (ie, high versus low IRG signature) [ Time Frame: Up to 52 weeks ]


Information from the National Library of Medicine

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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:

  • Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit
  • Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
  • One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory
  • Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash [score must be confirmed by Central Review Services (CRS)]
  • Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • 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 electrocardiogram (ECG)
  • History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria apply


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


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: July 21, 2021
Last Verified: July 2021

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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