Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172726
• Other study ID #: DMVT-505-3004
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2, 2021
• Est. completion date: June 2026

Study information

• Verified date: September 2023
• Source: Dermavant Sciences, Inc.
• Contact: Philip Brown, MD, JD
• Phone: 480-666-0844
• Email: dermavantclinicaltrials[@]dermavant.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• tapinarof cream, 1%
applied topically once daily

Locations

Country	Name	City	State
Canada	Dermavant Clinical Site	Calgary	Alberta
Canada	Dermavant Clinical Site	Edmonton	Alberta
Canada	Dermavant Clinical Site	Markham	Ontario
Canada	Dermavant Clinical Site	Montréal	Quebec
Canada	Dermavant Clinical Trials	Oshawa	Ontario
Canada	Dermavant Clinical Site	Saint John's	Newfoundland and Labrador
Canada	Dermavant Clinical Site	Waterloo	Ontario
United States	Dermavant Clinical Site	Chicago	Illinois
United States	Dermavant Clinical Site	Clearwater	Florida
United States	Dermavant Clinical Site	Fairborn	Ohio
United States	Dermavant Clinical Site	Fountain Valley	California
United States	Dermavant Clinical Site	Indianapolis	Indiana
United States	Dermavant Clinical Site	Miami Lakes	Florida
United States	Dermavant Clinical Site	Portland	Oregon
United States	Dermavant Clinical Site	Rancho Santa Margarita	California
United States	Dermavant Clinical Site	Rogers	Arkansas
United States	Dermavant Clinical Site	Spokane	Washington
United States	Dermavant Clinical Site	Spokane	Washington
United States	Dermavant Clinical Site	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Dermavant Sciences, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs) and Serious Adverse Events (SAEs)	Incidence, frequency, and duration of treatment emergent AEs and SAEs	Screening up to Week 53
Primary	Number of subjects with clinically significant laboratory test abnormalities		Screening up to Week 53
Primary	Number of subjects with clinically significant vital signs abnormalities		Screening up to Week 53
Primary	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
Primary	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	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
Secondary	Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.	Maximum observed plasma concentration (Cmax).	Week 4 and Week 12
Secondary	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