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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
19/11/2024

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.