Back to resultsA Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Primary Purpose
Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Deucravacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Discoid focused on measuring BMS-986165, Deucravacitinib, DLE, Discoid Lupus Erythematosus, SCLE, Subacute Cutaneous Lupus Erythematosus
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
Sites / Locations
- Mayo Clinic in Arizona - ScottsdaleRecruiting
- University of California, Irvine
- Local Institution - 0046Recruiting
- UConn HealthRecruiting
- UConn Health
- University of Central Florida College of Medicine
- University Of MichiganRecruiting
- Washington University School Of MedicineRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- Duke Health Center South DurhamRecruiting
- Cleveland Clinic
- Local Institution
- Ohio State University Wexner Medical Centre-Dermatology WestRecruiting
- Oklahoma Medical Research Foundation-ORRCRecruiting
- Clinical Research Center of the CarolinasRecruiting
- Local Institution
- Stat Research S.A.-DermatologyRecruiting
- Local Institution - 0013Recruiting
- Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-RheumatologyRecruiting
- Local Institution
- Local Institution - 0003
- Local Institution - 0001Recruiting
- Local Institution - 0002
- Local Institution - 0007Recruiting
- Local Institution - 0078
- CHU de Bordeaux Hop St ANDRE-Service de DermatologieRecruiting
- HENRI MONDOR HOSPITAL-dermatologyRecruiting
- Hôpital Tenon-Dermatology and allergologyRecruiting
- Local Institution - 0072Recruiting
- Local Institution - 0035Recruiting
- Local Institution - 0014Recruiting
- Local Institution - 0006Recruiting
- Local Institution - 0071Recruiting
- Local Institution
- Local Institution - 0058Recruiting
- Local Institution - 0036Recruiting
- Local Institution - 0029Recruiting
- Local Institution - 0028Recruiting
- Local Institution - 0005Recruiting
- Local Institution - 0009Recruiting
- Local Institution - 0008Recruiting
- Local Institution
- Local Institution
- Local Institution
- Local Institution - 0031Recruiting
- Local Institution - 0023Recruiting
- Local Institution - 0021Recruiting
- Local Institution - 0022Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Active Treatment: Deucravacitinib Dose 1
Active Treatment: Deucravacitinib Dose 2
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16
Secondary Outcome Measures
Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI- 50)
Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline
Mean change from baseline in CLASI-A score
Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0"
Incidence of serious adverse events (SAEs)
Incidence of adverse events (AEs)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis
Incidence of clinically significant changes in vital signs: Body temperature
Incidence of clinically significant changes in vital signs: Respiratory rate
Incidence of clinically significant changes in vital signs: Blood pressure
Incidence of clinically significant changes in vital signs: Heart rate
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
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
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
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Full Information
NCT ID
NCT04857034
First Posted
April 20, 2021
Last Updated
September 29, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT04857034
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
June 20, 2025 (Anticipated)
Study Completion Date
February 27, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous
Keywords
BMS-986165, Deucravacitinib, DLE, Discoid Lupus Erythematosus, SCLE, Subacute Cutaneous Lupus Erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment: Deucravacitinib Dose 1
Arm Type
Experimental
Arm Title
Active Treatment: Deucravacitinib Dose 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Deucravacitinib
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI- 50)
Time Frame
Week 16
Title
Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline
Time Frame
Week 16
Title
Mean change from baseline in CLASI-A score
Time Frame
Week 16
Title
Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0"
Time Frame
Week 16
Title
Incidence of serious adverse events (SAEs)
Time Frame
Up to 60 weeks
Title
Incidence of adverse events (AEs)
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in clinical laboratory results: Urinalysis
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Description
PR interval: The time from the onset of the P wave to the start of the QRS complex
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Description
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Description
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Time Frame
Up to 56 weeks
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Description
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Time Frame
Up to 56 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic in Arizona - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Mangold, Site 0077
Phone
480-301-8000
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Min, Site 0076
Phone
949-824-7103
Facility Name
Local Institution - 0046
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0046
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Lu, Site 0073
Phone
507-398-2679
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Central Florida College of Medicine
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveed Sami, Site 0082
Phone
407-266-8742
Facility Name
University Of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mio Nakamura, Site 0060
Phone
734-232-0652
Facility Name
Washington University School Of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Musiek, Site 0059
Phone
314-362-8171
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Gottlieb, Site 0037
Phone
212-844-8625
Facility Name
Duke Health Center South Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Marano, Site 0065
Phone
919-385-7546
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Fernandez, Site 0084
Phone
216-445-8776
Facility Name
Local Institution
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
Facility Name
Ohio State University Wexner Medical Centre-Dermatology West
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Kaffenberger, Site 0067
Phone
614-984-6814
Facility Name
Oklahoma Medical Research Foundation-ORRC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Arriens, Site 0026
Phone
405-271-7805
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Schlesinger, Site 0054
Phone
843-556-8886
Facility Name
Local Institution
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Withdrawn
Facility Name
Stat Research S.A.-Dermatology
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1023
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Zarowsky, Site 0018
Phone
+5491154771812
Facility Name
Local Institution - 0013
City
San Miguel De Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Rheumatology
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Analia Alvarez, Site 0019
Phone
1144971886
Facility Name
Local Institution
City
Cordoba
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0003
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Individual Site Status
Completed
Facility Name
Local Institution - 0001
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0002
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3142
Country
Australia
Individual Site Status
Completed
Facility Name
Local Institution - 0007
City
Clayton
State/Province
Victoria
ZIP/Postal Code
0
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007
Facility Name
Local Institution - 0078
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0078
Facility Name
CHU de Bordeaux Hop St ANDRE-Service de Dermatologie
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Seneschal, Site 0038
Phone
33556794705
Facility Name
HENRI MONDOR HOSPITAL-dermatology
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Diaz, Site 0027
Phone
0033149812501
Facility Name
Hôpital Tenon-Dermatology and allergology
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Chasset, Site 0010
Phone
+33156017225.
Facility Name
Local Institution - 0072
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0072
Facility Name
Local Institution - 0035
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0014
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0006
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0071
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0071
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45030
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0058
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0058
Facility Name
Local Institution - 0036
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0029
City
Aguascalientes
ZIP/Postal Code
20130
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0028
City
Guadalajara
ZIP/Postal Code
0
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0005
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution - 0009
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0009
Facility Name
Local Institution - 0008
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
94-046
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0008
Facility Name
Local Institution
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
121205
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0031
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031
Facility Name
Local Institution - 0023
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0021
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0022
City
Taipei
ZIP/Postal Code
10051
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
Learn more about this trial
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
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