Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

April 16, 2026 updated by: Organon and Co

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Clinical Lead Late-Stage Clinical Development
  • Phone Number: 551-430-6000
  • Email: studysites@organon.com

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J7E1
        • Dermatology Research Institute Inc.
      • Edmonton, Alberta, Canada, T5J3S9
        • Rejuvenation Laser Dermatology Clinics
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E1V4
        • Skincare Studio INC
    • Ontario
      • Markham, Ontario, Canada, L3P1X3
        • Lynderm Research Inc.
      • Waterloo, Ontario, Canada, N2J 1C4
        • Alliance Clinical Trials
      • Whitby, Ontario, Canada, L1P0P9
        • Whitby Health Centre Dermatology Trials
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research, Inc.
  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Clinical Trials Center, PLLC
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Rancho Santa Margarita, California, United States, 92688
        • Mission dermatology Center
    • Florida
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research Clinic, Inc.
      • Miami Lakes, Florida, United States, 33014
        • RM Medical Research
      • Tampa, Florida, United States, 33615
        • Olympian Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group
      • West Lafayette, Indiana, United States, 47906
        • Options Research Group
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians Pharmacology Translational Unit
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology & Research Center
    • Washington
      • Spokane, Washington, United States, 99202
        • Dermatology Specialists of Spokane

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Open Label
Drug: tapinarof cream, 1%
applied topically once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Organon and Co

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Lead Late-Stage Clinical Development, Organon and Co

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMVT-505-3004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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