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A Study to Evaluate Efficacy and Safety of BMS-986165 in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

  • Clinicaltrials.gov identifier

    NCT04857034

  • Recruitment Status

    Recruiting

  • First Posted

    April 23, 2021

  • Last update posted

    December 21, 2021

Study Description

Brief summary:

The purpose of this study is to assess the safety, efficacy, and tolerability of BMS-986165 compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if BMS-986165 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:Lupus Erythematosus, Discoid
    Lupus Erythematosus, Subacute Cutaneous
  • Intervention/Treatment: Drug: BMS-986165
    Drug: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 BMS-986165 in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
  • Actual Study Start Date: July 2021
  • Estimated Primary Completion Date: October 2023
  • Estimated Study Completion Date: July 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Active Treatment: BMS-986165 Dose 1
Drug: BMS-986165
Specified dose on specified days
Experimental: Active Treatment: BMS-986165 Dose 2
Drug: BMS-986165
Specified dose on specified days
Placebo Comparator: Placebo
Drug: Placebo
Specified dose on specified days

Outcome Measures

  • 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

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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 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

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
Local Institution
Los Angeles

United States, Michigan
Local Institution
Ann Arbor

United States, Missouri
Local Institution
Saint Louis

United States, New York
Local Institution
New York

United States, North Carolina
Local Institution
Durham

United States, Ohio
Local Institution
Columbus

United States, Ohio
Local Institution
Columbus

United States, Oklahoma
Local Institution
Oklahoma City

United States, South Carolina
Local Institution
Charleston

United States, South Dakota
Local Institution
Rapid City

Argentina, Buenos Aires
Local Institution
C.a.b.a.

Argentina, Buenos Aires
Stat Research S.A.-Dermatology
Caba

Argentina, Tucuman
Centro Medico Privado De Reumatologia
San Miguel De Tucuman

Argentina
Local Institution
Cordoba

Australia, New South Wales
Local Institution
Botany

Australia, New South Wales
Local Institution
Sydney

Australia, Victoria
Local Institution
Camberwell

Australia, Victoria
Local Institution
Clayton

France
Local Institution
Bordeaux

France
HENRI MONDOR HOSPITAL-dermatology
Creteil

France
Hôpital Tenon-Dermatology and allergology
Paris

France
Local Institution
Strasbourg

Germany
Charité Universitaetsmedizin Berlin-Klinik für Dermatologie Venerologie und Allerologie
Berlin

Germany
Universitaetsklinikum Erlangen-Hautklinik
Erlangen

Germany
MENSINGDERMA research
Hamburg

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Zapopan

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico
Local Institution
Aguascalientes

Poland
Local Institution
Lodz

Poland
Local Institution
Rzeszów

Poland
Local Institution
Wroclaw

Russian Federation
Local Institution
Kemerovo

Russian Federation
Local Institution
Moscow

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taipei

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04857034 History of Changes
  • Other Study ID Numbers: IM011-132, 2020-000071-21, U1111-1246-1726
  • First Posted: April 23, 2021 Key Record Dates
  • Last Update Posted: December 21, 2021
  • Last Verified: December 2021
  • 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
    DLE
    Discoid Lupus Erythematosus
    SCLE
    Subacute Cutaneous Lupus Erythematosus
  • Additional relevant MeSH terms: Lupus Erythematosus, Systemic
    Lupus Erythematosus, Cutaneous
    Lupus Erythematosus, Discoid
    Connective Tissue Diseases
    Autoimmune Diseases
    Immune System Diseases
    Skin Diseases