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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04857034
Other study ID # IM011-132
Secondary ID 2020-000071-21U1
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 12, 2021
Est. completion date May 2, 2025

Study information

Verified date April 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 75
Est. completion date May 2, 2025
Est. primary completion date July 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days

Locations

Country Name City State
Argentina Local Institution - 0019 Buenos Aires
Argentina Local Institution - 0018 Capital Federal Buenos Aires
Argentina Local Institution - 0013 San Miguel De Tucuman Tucuman
Australia Local Institution - 0003 Botany New South Wales
Australia Local Institution - 0002 Camberwell Victoria
Australia Local Institution - 0007 Clayton Victoria
Australia Local Institution - 0001 Kogarah New South Wales
Australia Local Institution - 0078 Melbourne Victoria
Australia Local Institution - 0087 Victoria Park Western Australia
France Local Institution - 0038 Bordeaux
France Local Institution - 0027 Créteil
France Local Institution - 0010 Paris
Germany Local Institution - 0035 Berlin
Germany Local Institution - 0072 Dresden Sachsen
Germany Local Institution - 0014 Erlangen
Germany Local Institution - 0006 Hamburg
Mexico Local Institution - 0029 Aguascalientes
Mexico Local Institution Guadalajara Jalisco
Mexico Local Institution - 0028 Guadalajara
Mexico Local Institution - 0071 Mexico City Distrito Federal
Mexico Local Institution - 0036 Monterrey Nuevo LEON
Mexico Local Institution - 0058 Zapopan Jalisco
Poland Local Institution - 0008 Lodz Lódzkie
Poland Local Institution - 0005 Rzeszów
Poland Local Institution - 0009 Wroclaw
Taiwan Local Institution - 0031 Kaohsiung
Taiwan Local Institution - 0021 Taichung
Taiwan Local Institution - 0023 Taichung City
Taiwan Local Institution - 0022 Taipei
United States Local Institution - 0060 Ann Arbor Michigan
United States Local Institution - 0054 Charleston South Carolina
United States Local Institution - 0067 Columbus Ohio
United States Local Institution - 0065 Durham North Carolina
United States Local Institution - 0073 Farmington Connecticut
United States Local Institution - 0076 Irvine California
United States Local Institution - 0046 Los Angeles California
United States Local Institution - 0037 New York New York
United States Local Institution - 0026 Oklahoma City Oklahoma
United States Local Institution - 0082 Orlando Florida
United States Local Institution - 0059 Saint Louis Missouri
United States Local Institution - 0077 Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  France,  Germany,  Mexico,  Poland,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16 Week 16
Secondary Percentage of participants with an improvement of = 50% from baseline in the CLASI-A score (CLASI- 50) Week 16
Secondary Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of = 4 points from baseline Week 16
Secondary Mean change from baseline in CLASI-A score Week 16
Secondary Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0" Week 16
Secondary Incidence of serious adverse events (SAEs) Up to 60 weeks
Secondary Incidence of adverse events (AEs) Up to 56 weeks
Secondary Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 56 weeks
Secondary Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests Up to 56 weeks
Secondary Incidence of clinically significant changes in clinical laboratory results: Urinalysis Up to 56 weeks
Secondary Incidence of clinically significant changes in vital signs: Body temperature Up to 56 weeks
Secondary Incidence of clinically significant changes in vital signs: Respiratory rate Up to 56 weeks
Secondary Incidence of clinically significant changes in vital signs: Blood pressure Up to 56 weeks
Secondary Incidence of clinically significant changes in vital signs: Heart rate Up to 56 weeks
Secondary Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval PR interval: The time from the onset of the P wave to the start of the QRS complex Up to 56 weeks
Secondary Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization Up to 56 weeks
Secondary Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval QT interval: Measured from the beginning of the QRS complex to the end of the T wave Up to 56 weeks
Secondary Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) Up to 56 weeks
See also
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