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

Bristol-Myers Squibb13 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lupus Erythematosus, Cutaneous

Interventions

BMS-986256DRUG

Specified Dose on Specified Days

BMS-986256 PlaceboOTHER

Specified Dose on Specified Days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution - 0001

Berlin, Germany

Outcomes

Primary Outcomes

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 Outcomes

Data from ClinicalTrials.gov

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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