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A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous 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: NCT04493541
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE July 28, 2020
First Posted Date  ICMJE July 30, 2020
Last Update Posted Date July 1, 2022
Actual Study Start Date  ICMJE August 26, 2020
Estimated Primary Completion Date October 16, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2020)
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 24 weeks ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 20 weeks ]
  • Number of laboratory test abnormalities: Hematology [ Time Frame: Up to 20 weeks ]
  • Number of laboratory test abnormalities: Urinalysis [ Time Frame: Up to 20 weeks ]
  • Number of laboratory test abnormalities: Clinical Chemistry [ Time Frame: Up to 20 weeks ]
  • Incidence of clinically significant changes in physical examination findings [ Time Frame: Up to 20 weeks ]
  • Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 20 weeks ]
  • Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 20 weeks ]
  • Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 20 weeks ]
  • Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 20 weeks ]
  • Incidence of clinically significant changes in Electrocardiogram (ECG) parameters [ Time Frame: Up to 20 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2020)
  • Maximum observed plasma concentration (Cmax) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  • Time to maximum concentration (Tmax) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  • Trough observed plasma concentration (Ctrough) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  • Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  • Maximum observed plasma concentration (Cmax) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
  • Time to maximum concentration (Tmax) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
  • Trough observed plasma concentration (Ctrough) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
  • Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
Official Title  ICMJE A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
Brief Summary The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lupus Erythematosus, Cutaneous
Intervention  ICMJE
  • Drug: BMS-986256
    Specified Dose on Specified Days
  • Other: BMS-986256 Placebo
    Specified Dose on Specified Days
Study Arms  ICMJE
  • Experimental: BMS-986256
    Intervention: Drug: BMS-986256
  • Placebo Comparator: Placebo
    Intervention: Other: BMS-986256 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: July 28, 2020)		 24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 16, 2023
Estimated Primary Completion Date October 16, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

a) Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE): Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to biopsy

• Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception, if applicable

Exclusion Criteria:

  • Active severe or unstable neuropsychiatric SLE
  • Active, severe Lupus Nephritis (LN)
  • Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the constitutional, musculoskeletal and/or mucocutaneous domains

Other protocol-defined inclusion/exclusion criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04493541
Other Study ID Numbers  ICMJE IM026-027
2019-004044-29 ( EudraCT Number )
Has Data Monitoring Committee No
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
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2022

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