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Trial record 1 of 1 for:    IM011-132
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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 : May 23, 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, 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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Discoid Lupus Erythematosus, Subacute Cutaneous Drug: Deucravacitinib Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : June 20, 2025
Estimated Study Completion Date : February 27, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Treatment: Deucravacitinib Dose 1 Drug: Deucravacitinib
Specified dose on specified days
Experimental: Active Treatment: Deucravacitinib Dose 2 Drug: Deucravacitinib
Specified dose on specified days
Placebo Comparator: Placebo Drug: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16 [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI- 50) [ Time Frame: Week 16 ]
  2. Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline [ Time Frame: Week 16 ]
  3. Mean change from baseline in CLASI-A score [ Time Frame: Week 16 ]
  4. Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0" [ Time Frame: Week 16 ]
  5. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 60 weeks ]
  6. Incidence of adverse events (AEs) [ Time Frame: Up to 56 weeks ]
  7. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 56 weeks ]
  8. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 56 weeks ]
  9. Incidence of clinically significant changes in clinical laboratory results: Urinalysis [ Time Frame: Up to 56 weeks ]
  10. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 56 weeks ]
  11. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 56 weeks ]
  12. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 56 weeks ]
  13. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 56 weeks ]
  14. 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

  15. 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

  16. 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

  17. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04857034


Contacts
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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 #.

Locations
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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: NCT04857034    
Other Study ID Numbers: IM011-132
2020-000071-21 ( EudraCT Number )
U1111-1246-1726 ( Registry Identifier: WHO )
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986165
Deucravacitinib
DLE
 Discoid Lupus Erythematosus
SCLE
Subacute Cutaneous Lupus Erythematosus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Skin Diseases
Deucravacitinib
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action