What side effects are associated with this type of intervention?

Common treatments for Discoid Lupus Erythematosus (DLE) include antimalarials like hydroxychloroquine and immunosuppressants such as methotrexate. Hydroxychloroquine can cause cutaneous drug eruptions, including morbilliform eruptions, bullae, and drug reaction with eosinophilia and systemic symptoms (DRESS). Methotrexate may lead to side effects such as liver toxicity, bone marrow suppression, and gastrointestinal disturbances. Deucravacitinib, a selective TYK2 inhibitor, is being studied for its safety and efficacy in DLE, and while specific side effects are not detailed, similar agents may cause infections, gastrointestinal issues, and potential liver enzyme elevations.

What prior FDA approvals exist?

There is limited information on prior FDA approvals specifically for Discoid Lupus Erythematosus (DLE). Traditional treatments for DLE often include antimalarial drugs like hydroxychloroquine and immunosuppressive agents such as methotrexate. Deucravacitinib, a selective TYK2 inhibitor, represents a novel approach targeting specific pathways involved in the immune response. While there are no direct FDA-approved TYK2 inhibitors for DLE, the study of Deucravacitinib may pave the way for new targeted therapies in this area.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for Discoid Lupus Erythematosus patients include other selective Janus kinase (JAK) inhibitors such as Tofacitinib and Baricitinib, which have shown efficacy in autoimmune conditions like rheumatoid arthritis and psoriatic arthritis. Additionally, biologic agents targeting B-cell activity, such as Rituximab, and other immunotherapies like intravenous immune globulin (IVIG) may also be considered based on their use in related autoimmune diseases.

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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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 56 weeks

Summary

This trial is testing a new medication called deucravacitinib to help people with certain types of lupus that aren't well managed by current treatments. The medication works by calming the immune system to reduce skin damage.

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.

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.

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 below

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I have been diagnosed with DLE/SCLE for at least 3 months.

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I am on a stable treatment plan for my skin condition with medication like corticosteroids, antimalarials, or immunosuppressants.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a specific type of skin lupus.

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I have lupus caused by medication.

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I have severe or unstable lupus affecting my nervous system.

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I have had a serious blood clot or unexplained pregnancy loss in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 56 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval

+1 more

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990

25%

COVID-19

13%

Pneumonia

13%

Nasopharyngitis

Cough

Pyrexia

Mouth ulceration

Upper respiratory tract infection

Urinary tract infection

Small intestinal obstruction

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

CROHN'S DISEASE

ULCERATIVE COLITIS

Trial 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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Deucravacitinib is a selective TYK2 inhibitor that works by blocking the activity of the TYK2 enzyme, which is involved in the signaling pathways of several cytokines that contribute to the inflammatory and immune responses in Discoid Lupus Erythematosus (DLE). By inhibiting TYK2, Deucravacitinib reduces the production of inflammatory cytokines, thereby decreasing inflammation and immune system activity that leads to the skin lesions characteristic of DLE. This mechanism is particularly important for DLE patients as it targets the underlying immune dysregulation, offering a potential treatment option for those whose disease is not well controlled with standard therapies.