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Janus Kinase (JAK) Inhibitor
Deucravacitinib for Cutaneous Lupus Erythematosus
Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 weeks
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of an experimental drug to a placebo in people with lupus erythematosus.
Who is the study for?
This trial is for individuals with active discoid or subacute cutaneous lupus erythematosus (DLE/SCLE) who have been diagnosed at least 3 months prior and are on a stable treatment regimen. It includes those with or without systemic lupus erythematosus (SLE), but excludes pregnant women, those with certain other autoimmune diseases, drug-induced CLE/SLE, severe neuropsychiatric SLE, or a history of multiple unexplained pregnancy losses.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Deucravacitinib compared to a placebo in participants with moderate to severe DLE/SCLE that's not well-managed by current treatments. The goal is to see if Deucravacitinib can improve skin conditions in these patients.See study design
What are the potential side effects?
While specific side effects for Deucravacitinib aren't listed here, common side effects may include nausea, headaches, possible skin reactions at the site of application or ingestion-related discomforts such as stomach pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with DLE/SCLE for at least 3 months.
Select...
I am on a stable treatment plan for my skin condition with medication like corticosteroids, antimalarials, or immunosuppressants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
Incidence of adverse events (AEs)
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
+14 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment: Deucravacitinib Dose 2Experimental Treatment1 Intervention
Group II: Active Treatment: Deucravacitinib Dose 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,757 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may or may not have lupus along with my current condition.I have a specific type of skin lupus.You have experienced three or more unexplained miscarriages in a row.I have lupus caused by medication.I have been diagnosed with DLE/SCLE for at least 3 months.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I am on a stable treatment plan for my skin condition with medication like corticosteroids, antimalarials, or immunosuppressants.I have severe or unstable lupus affecting my nervous system.I have had a serious blood clot or unexplained pregnancy loss in the last year.I have been on a stable dose of NSAIDs or painkillers for at least 2 weeks.I do not have autoimmune diseases that could affect my lupus assessment.I have been diagnosed with cutaneous lupus based on clinical and tissue examination.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Active Treatment: Deucravacitinib Dose 1
- Group 3: Active Treatment: Deucravacitinib Dose 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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