Tapinarof for Cutaneous Lupus

Recruiting in Palo Alto (17 mi)

Overseen by Paras Vakharia

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

We hypothesize that topical application of Tapinarof, an FDA-approved topical Aryl hydrocarbon receptor (AHR) agonist for the treatment of plaque psoriasis, would inhibit lupus-causing T cells and lead to improvement of cutaneous lupus lesions. To test this hypothesis, we will perform a prospective, interventional clinical trial in patients with chronic and/or subacute cutaneous lupus. This trial will include outcomes analyzing the change in cutaneous lupus lesions using standardized assessments, but also analyze pre- and post-treatment skin and blood immune parameters to elucidate the immune effects and changes in lupus as a result of topical AHR agonist application. The goals are to 1) identify if topical AHR agonism leads to improvement in cutaneous lupus, and 2) examine the immunopathology of cutaneous lupus and its alteration with topical AHR agonist treatment.

Research Team

Paras Vakharia

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for patients with chronic or subacute cutaneous lupus erythematosus. Participants should have persistent skin lesions characteristic of the condition. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with chronic or subacute cutaneous lupus.

I have a skin lupus lesion larger than 1cm with a moderate to severe score.

Exclusion Criteria

Patients who are pregnant or breast-feeding

I currently have an active infection.

History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the study drug

Treatment Details

Interventions

• Tapinarof (Aryl hydrocarbon receptor agonist)

Trial Overview The trial is testing Tapinarof, a medication approved for plaque psoriasis, to see if it can improve skin lesions in cutaneous lupus by inhibiting harmful T cells. It's an interventional study where changes in lesions will be measured before and after treatment, along with immune system analysis.

Participant Groups

Group I: Tapinarof Treatment Experimental Treatment 1 Intervention

CLE participants treated with tapinarof

Tapinarof is already approved in United States for the following indications:

🇺🇸 Approved in United States as Vtama for:

• Plaque psoriasis in adults
• Atopic dermatitis in adults and pediatric patients 2 years of age and older

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwestern University Department of Dermatology Chicago, IL

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1674

Patients Recruited

989,000+

References