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A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

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ClinicalTrials.gov Identifier: NCT04857034
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : October 24, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 20, 2021
First Posted Date  ICMJE April 23, 2021
Last Update Posted Date October 24, 2022
Actual Study Start Date  ICMJE July 12, 2021
Estimated Primary Completion Date October 16, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2021)		 Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16 [ Time Frame: Week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2021)
  • Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI- 50) [ Time Frame: Week 16 ]
  • Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline [ Time Frame: Week 16 ]
  • Mean change from baseline in CLASI-A score [ Time Frame: Week 16 ]
  • Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0" [ Time Frame: Week 16 ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 60 weeks ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to 56 weeks ]
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 56 weeks ]
  • Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 56 weeks ]
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis [ Time Frame: Up to 56 weeks ]
  • Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 56 weeks ]
  • Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 56 weeks ]
  • Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 56 weeks ]
  • Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 56 weeks ]
  • Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Up to 56 weeks ]
    PR interval: The time from the onset of the P wave to the start of the QRS complex
  • Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Up to 56 weeks ]
    QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
  • Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Up to 56 weeks ]
    QT interval: Measured from the beginning of the QRS complex to the end of the T wave
  • Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Up to 56 weeks ]
    QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Official Title  ICMJE A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Brief Summary The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lupus Erythematosus, Discoid
  • Lupus Erythematosus, Subacute Cutaneous
Intervention  ICMJE
  • Drug: Deucravacitinib
    Specified dose on specified days
  • Drug: Placebo
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Active Treatment: Deucravacitinib Dose 1
    Intervention: Drug: Deucravacitinib
  • Experimental: Active Treatment: Deucravacitinib Dose 2
    Intervention: Drug: Deucravacitinib
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2021)		 75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 18, 2024
Estimated Primary Completion Date October 16, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit
  • Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol
  • Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant
  • Participant could be with or without concurrent systemic lupus erythematosus (SLE)
  • If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening

Exclusion Criteria:

  • Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period
  • Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains
  • Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)
  • Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit
  • History of 3 or more unexplained consecutive pregnancy losses
  • Active severe or unstable neuropsychiatric SLE
  • Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity

Other protocol-defined inclusion/exclusion criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Argentina,   Australia,   France,   Germany,   Mexico,   Poland,   Russian Federation,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04857034
Other Study ID Numbers  ICMJE IM011-132
2020-000071-21 ( EudraCT Number )
U1111-1246-1726 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP