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

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

Study Overview

• Status: Completed
• Conditions: Lupus Erythematosus, Cutaneous
• Intervention / Treatment: Drug: BMS-986256; Other: BMS-986256 Placebo

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: BMS-986256 Placebo; Specified Dose on Specified Days
Experimental: BMS-986256	Drug: BMS-986256; Specified Dose on Specified Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Serious Adverse Events (SAEs)	Up to 24 weeks
Incidence of Adverse Events (AEs)	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 clinically significant changes in Electrocardiogram (ECG) parameters	Up to 20 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
• Other Study ID Numbers: IM026-027; 2019-004044-29 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No