Clinical trial NCT04493541: A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lupus Erythematosus, Cutaneous
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 24 weeks
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 20 weeks
measure: Number of laboratory test abnormalities: Hematology
timeFrame: Up to 20 weeks
measure: Number of laboratory test abnormalities: Urinalysis
timeFrame: Up to 20 weeks
measure: Number of laboratory test abnormalities: Clinical Chemistry
timeFrame: Up to 20 weeks
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 20 weeks
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 20 weeks
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 20 weeks
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 20 weeks
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 20 weeks
measure: Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986256
timeFrame: Up to 20 weeks
measure: Time to maximum concentration (Tmax) of BMS-986256
timeFrame: Up to 20 weeks
measure: Trough observed plasma concentration (Ctrough) of BMS-986256
timeFrame: Up to 20 weeks
measure: Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256
timeFrame: Up to 20 weeks
measure: Maximum observed plasma concentration (Cmax) of metabolite BMT-271199
timeFrame: Up to 20 weeks
measure: Time to maximum concentration (Tmax) of metabolite BMT-271199
timeFrame: Up to 20 weeks
measure: Trough observed plasma concentration (Ctrough) of metabolite BMT-271199
timeFrame: Up to 20 weeks
measure: Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: