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COMPLETEDPHASE1

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

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

NCT04493541•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Local Institution - 0001

Berlin, Germany

Key Dates

Start Date

August 26, 2020

Primary Completion Date

April 21, 2023

Completion Date

April 21, 2023

Last Updated

May 9, 2023

Enrollment

ACTUAL participants

Conditions

Lupus Erythematosus, Cutaneous

Interventions

BMS-986256

DRUG

BMS-986256 Placebo

OTHER

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous Lupus Erythematosus Subjects

NCT02927457

Lupus Erythematosus, Cutaneous

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COMPLETEDPHASE2

Targeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus

NCT02656082

Lupus Erythematosus, DiscoidLupus Erythematosus, Cutaneous+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous Lupus Erythematosus Subjects

Targeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus

European Society of Cutaneous Lupus Erythematosus (EUSCLE)

A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers