Cutaneous Lupus ErythematosusEarly Phase 1NCT06661213
Tapinarof for Cutaneous Lupus Erythematosus
A Early Phase 1 study testing Tapinarof in people with Cutaneous Lupus Erythematosus, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Lupus Erythematosus
- What is being tested?
- Tapinarof
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to Nov 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
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
- Being tested
- Tapinarof
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapinarofDrug
Also called VTAMA
A thin layer of tapinarof cream is applied to affected areas once daily.
| Study group | Role | What they receive |
|---|---|---|
| Tapinarof Treatment | Experimental | CLE participants treated with tapinarof Receives: Drug: Tapinarof |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start3 Apr 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paras Vakharia, Northwestern University
- Investigators
- Paras Vakharia, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661213
- Sponsor's protocol ID
- STU00222465
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tapinarof for Cutaneous Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06661213
- Acronym / sponsor ID
- STU00222465
- Conditions
- Cutaneous Lupus Erythematosus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tapinarof Treatment | Experimental | Drug: TapinarofCLE participants treated with tapinarof |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TapinarofAlso: VTAMAA thin layer of tapinarof cream is applied to affected areas once daily. | Drug | Tapinarof Treatment |
Primary outcome
Improvement in Cutaneous Lupus Activity (CLA) Investigator Global Assessment (IGA) - Revised (R) score
Time frame: 16 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) score
Time frame: 16 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paras Vakharia principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tapinarof in people with Cutaneous Lupus Erythematosus, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Cutaneous Lupus Activity (CLA) Investigator Global Assessment (IGA) - Revised (R) score (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.