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

NCT ID: NCT04493541

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2023-04-21

Brief Summary

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

Detailed Description

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Conditions

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Lupus Erythematosus, Cutaneous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BMS-986256

Group Type EXPERIMENTAL

BMS-986256

Intervention Type DRUG

Specified Dose on Specified Days

Placebo

Group Type PLACEBO_COMPARATOR

BMS-986256 Placebo

Intervention Type OTHER

Specified Dose on Specified Days

Interventions

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BMS-986256

Specified Dose on Specified Days

Intervention Type DRUG

BMS-986256 Placebo

Specified Dose on Specified Days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Berlin, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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2019-004044-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM026-027

Identifier Type: -

Identifier Source: org_study_id

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