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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04857034




Registration number
NCT04857034
Ethics application status
Date submitted
20/04/2021
Date registered
23/04/2021
Date last updated
19/09/2024

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Scientific 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)
Secondary ID [1] 0 0
2020-000071-21
Secondary ID [2] 0 0
IM011-132
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Erythematosus, Discoid 0 0
Lupus Erythematosus, Subacute Cutaneous 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Deucravacitinib
Treatment: Drugs - Placebo

Experimental: Active Treatment: Deucravacitinib Dose 1 -

Experimental: Active Treatment: Deucravacitinib Dose 2 -

Placebo comparator: Placebo -


Treatment: Drugs: Deucravacitinib
Specified dose on specified days

Treatment: Drugs: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of participants with an improvement of = 50% from baseline in the CLASI-A score (CLASI- 50)
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of = 4 points from baseline
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Mean change from baseline in CLASI-A score
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0"
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [5] 0 0
Up to 60 weeks
Secondary outcome [6] 0 0
Incidence of adverse events (AEs)
Timepoint [6] 0 0
Up to 56 weeks
Secondary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [7] 0 0
Up to 56 weeks
Secondary outcome [8] 0 0
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Timepoint [8] 0 0
Up to 56 weeks
Secondary outcome [9] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis
Timepoint [9] 0 0
Up to 56 weeks
Secondary outcome [10] 0 0
Incidence of clinically significant changes in vital signs: Body temperature
Timepoint [10] 0 0
Up to 56 weeks
Secondary outcome [11] 0 0
Incidence of clinically significant changes in vital signs: Respiratory rate
Timepoint [11] 0 0
Up to 56 weeks
Secondary outcome [12] 0 0
Incidence of clinically significant changes in vital signs: Blood pressure
Timepoint [12] 0 0
Up to 56 weeks
Secondary outcome [13] 0 0
Incidence of clinically significant changes in vital signs: Heart rate
Timepoint [13] 0 0
Up to 56 weeks
Secondary outcome [14] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Timepoint [14] 0 0
Up to 56 weeks
Secondary outcome [15] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Timepoint [15] 0 0
Up to 56 weeks
Secondary outcome [16] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Timepoint [16] 0 0
Up to 56 weeks
Secondary outcome [17] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Timepoint [17] 0 0
Up to 56 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2028
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0003 - Botany
Recruitment hospital [2] 0 0
Local Institution - 0001 - Kogarah
Recruitment hospital [3] 0 0
Local Institution - 0002 - Camberwell
Recruitment hospital [4] 0 0
Local Institution - 0007 - Clayton
Recruitment hospital [5] 0 0
Local Institution - 0078 - Melbourne
Recruitment hospital [6] 0 0
Local Institution - 0087 - Victoria Park
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
0 - Clayton
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Tucuman
Country [14] 0 0
France
State/province [14] 0 0
Bordeaux
Country [15] 0 0
France
State/province [15] 0 0
Créteil
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
Germany
State/province [17] 0 0
Sachsen
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Erlangen
Country [20] 0 0
Germany
State/province [20] 0 0
Hamburg
Country [21] 0 0
Mexico
State/province [21] 0 0
Jalisco
Country [22] 0 0
Mexico
State/province [22] 0 0
Nuevo LEON
Country [23] 0 0
Mexico
State/province [23] 0 0
Aguascalientes
Country [24] 0 0
Mexico
State/province [24] 0 0
Guadalajara
Country [25] 0 0
Mexico
State/province [25] 0 0
Mexico City
Country [26] 0 0
Poland
State/province [26] 0 0
Rzeszów
Country [27] 0 0
Poland
State/province [27] 0 0
Wroclaw
Country [28] 0 0
Poland
State/province [28] 0 0
Lódzkie
Country [29] 0 0
Taiwan
State/province [29] 0 0
Kaohsiung
Country [30] 0 0
Taiwan
State/province [30] 0 0
Taichung City
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taichung
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04857034
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04857034