Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.

Detailed Description
-----------------
This study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. At the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. Subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.

Official Title
-----------------
A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: tapinarof cream, 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline A PGA score of ≥ 2 at screening and baseline Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods Must not be pregnant Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent Exclusion Criteria: Psoriasis other than plaque variant Any sign of infection of any of the psoriatic lesions Immunocompromised at screening Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN) Screening total bilirubin > 1.5x ULN Current or chronic history of liver disease Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix Major surgery within 8 weeks prior to baseline or has a major surgery planned during the study Known history of clinically significant drug or alcohol abuse in the last year prior to baseline Use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion may interfere with the subject's participation in the study, interpretation of results, safety of the subject or ability to understand and give informed consent Pregnant or lactating females. History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br> | Drug: tapinarof cream, 1%<br>* applied topically once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence, frequency, and duration of treatment emergent AEs and SAEs | Screening up to Week 53 | 
| Number of subjects with clinically significant laboratory test abnormalities |  | Screening up to Week 53 | 
| Number of subjects with clinically significant vital signs abnormalities |  | Screening up to Week 53 | 
| Investigator-Assessed Local Tolerability Scale (LTS) Scores | Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation. | Baseline up to Week 52 | 
| Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS) | Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation. | Baseline up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%. | Area under the plasma concentration-time curve from time zero to the last quantifiable time point. | Week 4 and Week 12 | 
| Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%. | Maximum observed plasma concentration (Cmax). | Week 4 and Week 12 | 
| Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%. | Time to maximum observed plasma concentration obtained directly from the observed concentration. | Week 4 and Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plaque psoriasis, pediatric, phase 3, topical, tapinarof