Clinical trial NCT04857034: A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Lupus Erythematosus, Discoid
Lupus Erythematosus, Subacute Cutaneous
Keywords: BMS-986165
Deucravacitinib
DLE
Discoid Lupus Erythematosus
SCLE
Subacute Cutaneous Lupus Erythematosus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI- 50)
timeFrame: Week 16
measure: Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline
timeFrame: Week 16
measure: Mean change from baseline in CLASI-A score
timeFrame: Week 16
measure: Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0"
timeFrame: Week 16
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 60 weeks
measure: Incidence of adverse events (AEs)
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
timeFrame: Up to 56 weeks
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
timeFrame: Up to 56 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Local Institution - 0077
state: Arizona
city: Irvine
country: United States
facility: Local Institution - 0076
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0046
state: California
city: Farmington
country: United States
facility: Local Institution - 0073
state: Connecticut
city: Orlando
country: United States
facility: Local Institution - 0082
state: Florida
city: Ann Arbor
country: United States
facility: Local Institution - 0060
state: Michigan
city: Saint Louis
country: United States
facility: Local Institution - 0059
state: Missouri
city: New York
country: United States
facility: Local Institution - 0037
state: New York
city: Durham
country: United States
facility: Local Institution - 0065
state: North Carolina
city: Columbus
country: United States
facility: Local Institution - 0067
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 0026
state: Oklahoma
city: Charleston
country: United States
facility: Local Institution - 0054
state: South Carolina
city: Capital Federal
country: Argentina
facility: Local Institution - 0018
state: Buenos Aires
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution - 0013
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution - 0019
city: Botany
country: Australia
facility: Local Institution - 0003
state: New South Wales
city: Kogarah
country: Australia
facility: Local Institution - 0001
state: New South Wales
city: Camberwell
country: Australia
facility: Local Institution - 0002
state: Victoria
city: Clayton
country: Australia
facility: Local Institution - 0007
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0078
state: Victoria
city: Victoria Park
country: Australia
facility: Local Institution - 0087
state: Western Australia
city: Bordeaux
country: France
facility: Local Institution - 0038
city: Créteil
country: France
facility: Local Institution - 0027
city: Paris
country: France
facility: Local Institution - 0010
city: Dresden
country: Germany
facility: Local Institution - 0072
state: Sachsen
city: Berlin
country: Germany
facility: Local Institution - 0035
city: Erlangen
country: Germany
facility: Local Institution - 0014
city: Hamburg
country: Germany
facility: Local Institution - 0006
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution - 0058
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0036
state: Nuevo LEON
city: Aguascalientes
country: Mexico
facility: Local Institution - 0029
city: Guadalajara
country: Mexico
facility: Local Institution - 0028
city: Mexico City
country: Mexico
facility: Local Institution - 0071
city: Rzeszów
country: Poland
facility: Local Institution - 0005
city: Wroclaw
country: Poland
facility: Local Institution - 0009
city: Lodz
country: Poland
facility: Local Institution - 0008
state: Łódzkie
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0031
city: Taichung City
country: Taiwan
facility: Local Institution - 0023
city: Taichung
country: Taiwan
facility: Local Institution - 0021
city: Taipei
country: Taiwan
facility: Local Institution - 0022
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: