Phase 2
Completed N=21
Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis
Source: ClinicalTrials.gov NCT04042103 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
May 2022
Primary outcomePrimary: Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) — 12; 6; 2; 0 Participants
Summary
This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) |
12; 6; 2; 0; 0; 1 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Irritation as Assessed by the Local Tolerability Scale |
14; 5; 1; 1; 0; 14 | — |
| PRIMARY Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: AUCo-tau |
8037.29; 1985.54 | — |
| PRIMARY Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Cmax |
898.33; 116.09 | — |
| PRIMARY Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Tmax and t1/2 |
4.39; 4.02; 6.41 | — |
| SECONDARY Change From Baseline in QTcF (ΔQTcF) at Each Post-treatment Time Point on the Sampling Day With the Higher Cmax (Day 1 or Day 29) |
-7.2; -1.1; -4.3; -2.3; -4.9; -3.0 | — |
| SECONDARY Analysis of the Relationship Between Plasma Concentration and ΔQTcF |
-0.00016 | — |
| SECONDARY Mean Change From Baseline to Day 29 in Physician's Global Assessment (PGA) |
-1.2 | — |
| SECONDARY Mean Change From Baseline to Day 29 Psoriasis Area and Severity Index (PASI) |
-15.14 | — |
| SECONDARY Mean Change From Baseline to Day 29 in Percent of Total Body Surface Area (%BSA) Affected |
-14.44 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects age 18 to 75 with a confirmed clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study
- BSA involvement ≥ 20%
- PGA score of ≥ 3 at screening
- Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
- Capable of giving written informed consent
Exclusion Criteria
- Psoriasis other than plaque variant
- Any sign of infection of any of the psoriatic lesions
- Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with the interpretation of the results
- Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
- Use of any prohibited medication within the indicated period before the first dose of study drug
- Pregnant females or lactating females
- The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
- Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- Previous known participation in a clinical study with tapinarof
Data sourced from ClinicalTrials.gov (NCT04042103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.