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Aryl hydrocarbon receptor agonist

Tapinarof for Cutaneous Lupus

Phase < 1
Waitlist Available
Led By Paras Vakharia
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years and older
Patients with a histopathological or clinical diagnosis of chronic and/or subacute CLE
Must not have
Patients with active infections
Prior use of anifrolumab within the last 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test if applying Tapinarof, a drug used for treating psoriasis, can improve skin lesions in patients with lupus. The study will measure changes in lupus lesions and immune

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of Tapinarof for this use aren't listed here, common ones from its use in psoriasis include skin irritation, redness, itching at the application site. As a topical drug, systemic side effects are less likely than oral medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with chronic or subacute cutaneous lupus.
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I have a skin lupus lesion larger than 1cm with a moderate to severe score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an active infection.
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I have not used anifrolumab in the last 6 months.
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My medication doses for immune system treatments have been stable for the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement in Cutaneous Lupus Activity (CLA) Investigator Global Assessment (IGA) - Revised (R) score
Improvement in the CLE Disease Area and Severity Index (CLASI)-Activity (A) score

Side effects data

From 2020 Phase 3 trial • 510 Patients • NCT03956355
23%
Folliculitis
7%
Nasopharyngitis
4%
Dermatitis contact
3%
Headache
2%
Pruritus
2%
Viral upper respiratory tract infection
1%
Back pain
1%
Cough
1%
abdominal pain
1%
Upper respiratory tract infection
1%
Influenza
1%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tapinarof (DMVT-505)
Vehicle Cream

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tapinarof TreatmentExperimental Treatment1 Intervention
CLE participants treated with tapinarof
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tapinarof
2023
Completed Phase 4
~1060

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,644 Previous Clinical Trials
958,458 Total Patients Enrolled
Paras VakhariaPrincipal InvestigatorNorthwestern University
~7 spots leftby Mar 2026
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