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

Phase 1

Completed

• Conditions: Lupus Erythematosus, Cutaneous
• Interventions: Drug: BMS-986256; Other: BMS-986256 Placebo

• Registration Number: NCT04493541
• Lead Sponsor: Bristol-Myers Squibb

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 available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Study Start: 2020-08-26
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-986256	BMS-986256	-
Placebo	BMS-986256 Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events (SAEs)	Up to 24 weeks
Incidence of Adverse Events (AEs)	Up to 20 weeks
Number of laboratory test abnormalities: Urinalysis	Up to 20 weeks
Number of laboratory test abnormalities: Clinical Chemistry	Up to 20 weeks
Number of laboratory test abnormalities: Hematology	Up to 20 weeks
Incidence of clinically significant changes in physical examination findings	Up to 20 weeks
Incidence of clinically significant changes in vital signs: Body temperature	Up to 20 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate	Up to 20 weeks
Incidence of clinically significant changes in vital signs: Blood pressure	Up to 20 weeks
Incidence of clinically significant changes in vital signs: Heart rate	Up to 20 weeks
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters	Up to 20 weeks

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of BMS-986256	Up to 20 weeks
Time to maximum concentration (Tmax) of BMS-986256	Up to 20 weeks
Trough observed plasma concentration (Ctrough) of BMS-986256	Up to 20 weeks
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256	Up to 20 weeks
Maximum observed plasma concentration (Cmax) of metabolite BMT-271199	Up to 20 weeks
Time to maximum concentration (Tmax) of metabolite BMT-271199	Up to 20 weeks
Trough observed plasma concentration (Ctrough) of metabolite BMT-271199	Up to 20 weeks
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199	Up to 20 weeks

Trial Locations

Locations (1)

Local Institution - 0001; 🇩🇪 Berlin, Germany