A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Lupus Erythematosus, Discoid Clinical Trial

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)

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
• 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
• 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

Related Conditions & MeSH terms

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting