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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04493541

Enrollment

Registered

2020-07-30

Start date

2020-08-26

Completion date

2023-04-21

Last updated

2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus, Cutaneous

Brief summary

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

Interventions

DRUGBMS-986256

Specified Dose on Specified Days

OTHERBMS-986256 Placebo

Specified Dose on Specified Days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters	Up to 20 weeks
Number of laboratory test abnormalities: Hematology	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
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 Serious Adverse Events (SAEs)	Up to 24 weeks
Incidence of Adverse Events (AEs)	Up to 20 weeks

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026