Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

September 7, 2023 updated by: Dermavant Sciences, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label
Drug: tapinarof cream, 1%
applied topically once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Screening up to Week 53
Incidence, frequency, and duration of treatment emergent AEs and SAEs
Screening up to Week 53
Number of subjects with clinically significant laboratory test abnormalities
Time Frame: Screening up to Week 53
Screening up to Week 53
Number of subjects with clinically significant vital signs abnormalities
Time Frame: Screening up to Week 53
Screening up to Week 53
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Time Frame: Baseline up to Week 52
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)
Time Frame: Baseline up to Week 52
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%.
Time Frame: Week 4 and Week 12
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%.
Time Frame: Week 4 and Week 12
Maximum observed plasma concentration (Cmax).
Week 4 and Week 12
Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.
Time Frame: Week 4 and Week 12
Time to maximum observed plasma concentration obtained directly from the observed concentration.
Week 4 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermavant Sciences, Inc.

Investigators

  • Study Director: Diana Villalobos, Dermavant Sciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2021

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMVT-505-3004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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