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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05172726
Other study ID # DMVT-505-3004
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
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