NCT06661213
Tapinarof for Cutaneous Lupus Erythematosus
Enrolling by Invitation
EARLY_PHASE1Ages 18+InterventionalTreatmentNorthwestern UniversityInvestigator-initiated
~10 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Tapinarof
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement in Cutaneous Lupus Activity (CLA) Investigator Global Assessment (IGA) - Revised (R) score
Measured over 16 weeks
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Paras Vakharia · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Improvement in Cutaneous Lupus Activity (CLA) Investigator Global Assessment (IGA) - Revised (R) score16 weeks
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)
- Improvement in the CLE Disease Area and Severity Index (CLASI)-Activity (A) score16 weeks
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