A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus

Overview

The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 21, 2023

Interventions

  • Drug: BMS-986256
    • Specified Dose on Specified Days
  • Other: BMS-986256 Placebo
    • Specified Dose on Specified Days

Arms, Groups and Cohorts

  • Experimental: BMS-986256
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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