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

Primary Purpose

Lupus Erythematosus, Cutaneous

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BMS-986256
BMS-986256 Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Cutaneous

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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/exclusion criteria apply

Sites / Locations

  • Local Institution - 0001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BMS-986256

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Serious Adverse Events (SAEs)
Incidence of Adverse Events (AEs)
Number of laboratory test abnormalities: Hematology
Number of laboratory test abnormalities: Urinalysis
Number of laboratory test abnormalities: Clinical Chemistry
Incidence of clinically significant changes in physical examination findings
Incidence of clinically significant changes in vital signs: Body temperature
Incidence of clinically significant changes in vital signs: Respiratory rate
Incidence of clinically significant changes in vital signs: Blood pressure
Incidence of clinically significant changes in vital signs: Heart rate
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters

Secondary Outcome Measures

Maximum observed plasma concentration (Cmax) of BMS-986256
Time to maximum concentration (Tmax) of BMS-986256
Trough observed plasma concentration (Ctrough) of BMS-986256
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256
Maximum observed plasma concentration (Cmax) of metabolite BMT-271199
Time to maximum concentration (Tmax) of metabolite BMT-271199
Trough observed plasma concentration (Ctrough) of metabolite BMT-271199
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199

Full Information

First Posted
July 28, 2020
Last Updated
May 8, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04493541
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
April 21, 2023 (Actual)
Study Completion Date
April 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Cutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986256
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986256
Intervention Description
Specified Dose on Specified Days
Intervention Type
Other
Intervention Name(s)
BMS-986256 Placebo
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to 24 weeks
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 20 weeks
Title
Number of laboratory test abnormalities: Hematology
Time Frame
Up to 20 weeks
Title
Number of laboratory test abnormalities: Urinalysis
Time Frame
Up to 20 weeks
Title
Number of laboratory test abnormalities: Clinical Chemistry
Time Frame
Up to 20 weeks
Title
Incidence of clinically significant changes in physical examination findings
Time Frame
Up to 20 weeks
Title
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame
Up to 20 weeks
Title
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame
Up to 20 weeks
Title
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame
Up to 20 weeks
Title
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame
Up to 20 weeks
Title
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
Time Frame
Up to 20 weeks
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of BMS-986256
Time Frame
Up to 20 weeks
Title
Time to maximum concentration (Tmax) of BMS-986256
Time Frame
Up to 20 weeks
Title
Trough observed plasma concentration (Ctrough) of BMS-986256
Time Frame
Up to 20 weeks
Title
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256
Time Frame
Up to 20 weeks
Title
Maximum observed plasma concentration (Cmax) of metabolite BMT-271199
Time Frame
Up to 20 weeks
Title
Time to maximum concentration (Tmax) of metabolite BMT-271199
Time Frame
Up to 20 weeks
Title
Trough observed plasma concentration (Ctrough) of metabolite BMT-271199
Time Frame
Up to 20 weeks
Title
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199
Time Frame
Up to 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0001
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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