Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

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: Active, not recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: tapinarof cream, 1%

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 (Actual): 58
• Phase: Phase 3

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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

Collaborators and Investigators

• Sponsor: Organon and Co
• Investigators: Study Director: Clinical Lead Late-Stage Clinical Development, Organon and Co

Publications and helpful links

General Publications

• Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, Kircik L. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 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): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pediatric; topical; plaque psoriasis; phase 3; tapinarof
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID 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