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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

Tracking Information
First Submitted Date  ICMJE August 15, 2017
First Posted Date  ICMJE August 17, 2017
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE June 13, 2017
Estimated Primary Completion Date December 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
Number of participants who meet response criteria for SLE Responder Index [SRI(4)] [ Time Frame: 32 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
Number of subjects who achieve British Isles Lupus Assessment Group 2004 Index (BILAG)-based Composite Lupus Assessment (BICLA) response [ Time Frame: 32 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
  • 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 ]
  • Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [ Time Frame: 32 weeks ]
  • Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [ Time Frame: 32 weeks ]
  • Distribution of participants experiencing serious adverse events (SAEs) [ Time Frame: 32 weeks ]
  • Distribution of participants experiencing adverse events (AEs) [ Time Frame: 32 weeks ]
  • Distribution of participants experiencing abnormalities in laboratory testing [ Time Frame: 48 weeks ]
  • Distribution of participants experiencing abnormalities in vital signs [ Time Frame: 48 weeks ]
  • Distribution of participants experiencing abnormalities in electrocardiograms (ECGs) [ Time Frame: 48 weeks ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: 48 weeks ]
  • Time of maximum observed plasma concentration (Tmax) [ Time Frame: 48 weeks ]
  • Trough observed plasma concentration (Ctrough) [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • Number of subjects who meet response criteria for SLE Responder Index [ Time Frame: 32 weeks ]
  • Number of subjects 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 ]
  • Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [ Time Frame: 32 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus
Official Title  ICMJE A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Brief Summary This study will investigate BMS-986165 to assess its effects in patients 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: BMS-986165
    administered orally
  • Other: Placebo
    administered orally
Study Arms  ICMJE
  • Experimental: BMS-986165 Dose 1 oral administration
    Intervention: Drug: BMS-986165
  • Experimental: BMS-986165 Dose 2 oral administration
    Intervention: Drug: BMS-986165
  • Experimental: BMS-986165 Dose 3 oral administration
    Intervention: Drug: BMS-986165
  • Placebo Comparator: Placebo oral administration
    Intervention: Other: Placebo
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: May 25, 2018)
360
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2017)
400
Estimated Study Completion Date  ICMJE December 3, 2021
Estimated Primary Completion Date December 3, 2021   (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:

  • 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

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,   Bulgaria,   Canada,   Colombia,   France,   Germany,   Hungary,   Israel,   Japan,   Korea, Republic of,   Mexico,   Peru,   Poland,   Romania,   Russian Federation,   Spain,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03252587
Other Study ID Numbers  ICMJE IM011-021
2017-001203-79 ( 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 September 2020

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