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

Lupus Erythematosus, Cutaneous Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04493541
• Other study ID #: IM026-027
• Secondary ID: 2019-004044-29
• Status: Completed
• Phase: Phase 1
• Start date: August 26, 2020
• Est. completion date: April 21, 2023

Study information

• Verified date: May 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 21, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

Drug:
• BMS-986256
Specified Dose on Specified Days

Other:
• BMS-986256 Placebo
Specified Dose on Specified Days

Locations

Country	Name	City	State
Germany	Local Institution - 0001	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Serious Adverse Events (SAEs)		Up to 24 weeks
Primary	Incidence of Adverse Events (AEs)		Up to 20 weeks
Primary	Number of laboratory test abnormalities: Hematology		Up to 20 weeks
Primary	Number of laboratory test abnormalities: Urinalysis		Up to 20 weeks
Primary	Number of laboratory test abnormalities: Clinical Chemistry		Up to 20 weeks
Primary	Incidence of clinically significant changes in physical examination findings		Up to 20 weeks
Primary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 20 weeks
Primary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 20 weeks
Primary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 20 weeks
Primary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 20 weeks
Primary	Incidence of clinically significant changes in Electrocardiogram (ECG) parameters		Up to 20 weeks
Secondary	Maximum observed plasma concentration (Cmax) of BMS-986256		Up to 20 weeks
Secondary	Time to maximum concentration (Tmax) of BMS-986256		Up to 20 weeks
Secondary	Trough observed plasma concentration (Ctrough) of BMS-986256		Up to 20 weeks
Secondary	Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256		Up to 20 weeks
Secondary	Maximum observed plasma concentration (Cmax) of metabolite BMT-271199		Up to 20 weeks
Secondary	Time to maximum concentration (Tmax) of metabolite BMT-271199		Up to 20 weeks
Secondary	Trough observed plasma concentration (Ctrough) of metabolite BMT-271199		Up to 20 weeks
Secondary	Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199		Up to 20 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls