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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04493541
Recruitment Status : Active, not recruiting
First Posted : July 30, 2020
Last Update Posted : February 9, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Cutaneous Drug: BMS-986256 Other: BMS-986256 Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 26, 2020
Estimated Primary Completion Date : October 16, 2023
Estimated Study Completion Date : October 16, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986256 Drug: BMS-986256
Specified Dose on Specified Days
Placebo Comparator: Placebo Other: BMS-986256 Placebo
Specified Dose on Specified Days


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 24 weeks ]
  2. Incidence of Adverse Events (AEs) [ Time Frame: Up to 20 weeks ]
  3. Number of laboratory test abnormalities: Hematology [ Time Frame: Up to 20 weeks ]
  4. Number of laboratory test abnormalities: Urinalysis [ Time Frame: Up to 20 weeks ]
  5. Number of laboratory test abnormalities: Clinical Chemistry [ Time Frame: Up to 20 weeks ]
  6. Incidence of clinically significant changes in physical examination findings [ Time Frame: Up to 20 weeks ]
  7. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 20 weeks ]
  8. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 20 weeks ]
  9. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 20 weeks ]
  10. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 20 weeks ]
  11. Incidence of clinically significant changes in Electrocardiogram (ECG) parameters [ Time Frame: Up to 20 weeks ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  2. Time to maximum concentration (Tmax) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  3. Trough observed plasma concentration (Ctrough) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  4. Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  5. Maximum observed plasma concentration (Cmax) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
  6. Time to maximum concentration (Tmax) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
  7. Trough observed plasma concentration (Ctrough) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
  8. Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493541


Locations
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Germany
Local Institution - 0001
Berlin, Germany, 10117
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04493541    
Other Study ID Numbers: IM026-027
2019-004044-29 ( EudraCT Number )
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Skin Diseases