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Completed

NCT Number: NCT04493541

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

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

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Key information

Conditions

Lupus Erythematosus, Cutaneous Connective Tissue Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986256

Drug

Specified Dose on Specified Days

BMS-986256 Placebo

Other

Specified Dose on Specified Days

Primary outcomes

  1. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 24 weeks

  2. Incidence of Adverse Events (AEs)

    Time frame: Up to 20 weeks

  3. Number of laboratory test abnormalities: Hematology

    Time frame: Up to 20 weeks

  4. Number of laboratory test abnormalities: Urinalysis

    Time frame: Up to 20 weeks

  5. Number of laboratory test abnormalities: Clinical Chemistry

    Time frame: Up to 20 weeks

  6. Incidence of clinically significant changes in physical examination findings

    Time frame: Up to 20 weeks

  7. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 20 weeks

  8. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 20 weeks

  9. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 20 weeks

  10. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 20 weeks

  11. Incidence of clinically significant changes in Electrocardiogram (ECG) parameters

    Time frame: Up to 20 weeks

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986256

    Time frame: Up to 20 weeks

  2. Time to maximum concentration (Tmax) of BMS-986256

    Time frame: Up to 20 weeks

  3. Trough observed plasma concentration (Ctrough) of BMS-986256

    Time frame: Up to 20 weeks

  4. Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256

    Time frame: Up to 20 weeks

  5. Maximum observed plasma concentration (Cmax) of metabolite BMT-271199

    Time frame: Up to 20 weeks

  6. Time to maximum concentration (Tmax) of metabolite BMT-271199

    Time frame: Up to 20 weeks

  7. Trough observed plasma concentration (Ctrough) of metabolite BMT-271199

    Time frame: Up to 20 weeks

  8. Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199

    Time frame: Up to 20 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 30, 2020
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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