Deucravacitinib for Cutaneous Lupus Erythematosus

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

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

Exclusion Criteria

I have a specific type of skin lupus.

I have lupus caused by medication.

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.

Treatment Details

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.

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

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Sotyktu for: