Tapinarof for Cutaneous Lupus Erythematosus

NCT06661213 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: STU00222465
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators 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, the investigators 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.

Conditions

Cutaneous Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Improvement in Cutaneous Lupus Activity (CLA) Investigator Global Assessment (IGA) - Revised (R) score

  Proportion of participants who achieve 0 or 1 on the CLA-IGA-R scale at Week 16 (5-point Likert scale 0-4, 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe)

  16 weeks

• Improvement in the CLE Disease Area and Severity Index (CLASI)-Activity (A) score

  Mean change in CLASI-A from Week 0 to Week 16.The maximum score for CLASI-A is 70 points, with a score of 0-9 indicating mild disease, 10-20 indicating moderate disease, and 21-70 indicating severe disease. A score of 0 indicates no active mucocutaneous lesions

  16 weeks

Study Arms (1)

Tapinarof Treatment

EXPERIMENTAL

CLE participants treated with tapinarof

Drug: Tapinarof

Interventions

Tapinarof DRUG

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

Also known as: VTAMA

Tapinarof Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Paras Vakharia

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: April 3, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)