Tapinarof for Cutaneous Lupus Erythematosus

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age 18 years and older.

- Patients with a histopathological or clinical diagnosis of chronic and/or subacute CLE.

- Patients with at least one active cutaneous lupus lesion with a diameter ≥ 1cm and CLA-IGA-R score of ≥ 3 at screening and baseline.

Exclusion Criteria:

- Unwillingness or inability to complete informed consent process or comply with the study protocol.

- Patients who are pregnant or breast-feeding.

- Other dermatologic diseases whose presence or treatments would interfere with evaluation of the study drug or interpretation of participant safety or trial results.

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

- Application to cutaneous lupus lesion(s) being assessed of topical corticosteroids, topical calcineurin inhibitors, or topical janus kinase inhibitors within 1 weeks of study drug initiation.

- Application to cutaneous lupus lesion(s) being assessed of topical tapinorof within 4 weeks of study drug initiation.

- Prior use of anifrolumab within the last 6 months.

- New initiation of systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, belimumab), antimalarials (hydroxychloroquine, chloroquine, quinacrine), or systemic janus kinase inhibitors within 12 weeks of study drug initiation.

- For patients already on the following treatment(s) prior to enrollment: unstable or changing of dosing of systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, belimumab), antimalarials (hydroxychloroquine, chloroquine, quinacrine), or systemic janus kinase inhibitors within 4 weeks of study drug initiation.

- Patients with active infections.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06661213
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Northwestern University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Paras Vakharia
Principal Investigator Affiliation	Northwestern University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cutaneous Lupus Erythematosus

Arms & Interventions

Arms

Experimental: Tapinarof Treatment

CLE participants treated with tapinarof

Interventions

Drug: - Tapinarof

A thin layer of tapinarof cream is applied to affected areas once daily.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Address

Northwestern University Department of Dermatology

Chicago, Illinois, 60611

Site Contact

Dermatology CTU

[email protected]

312-503-5944

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