Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

NCT05172726 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: DMVT-505-3004
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 19

Brief Summary

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

Conditions

Plaque Psoriasis

Keywords

plaque psoriasis; pediatric; phase 3; topical; tapinarof

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.

  Week 4 and Week 12

• Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.

  Week 4 and Week 12

• Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.

  Week 4 and Week 12

Study Arms (1)

Open Label

EXPERIMENTAL

Drug: tapinarof cream, 1%

Interventions

tapinarof cream, 1% DRUG

applied topically once daily

Open Label

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (19)

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, 72758, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Mission Dermatology Center

Rancho Santa Margarita, California, 92688, United States

Location

RM Medical Research

Miami Lakes, Florida, 33014, United States

Location

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

Location

Olympian Clinical Research

Tampa, Florida, 33615, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46250, United States

Location

Options Research Group

West Lafayette, Indiana, 47906, United States

Location

Wright State Physicians Pharmacology Translational Unit

Fairborn, Ohio, 45324, United States

Location

Oregon Dermatology & Research Center

Portland, Oregon, 97210, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Dermatology Research Institute Inc.

Calgary, Alberta, T2J7E1, Canada

Location

Rejuvenation Laser Dermatology Clinics

Edmonton, Alberta, T5J3S9, Canada

Location

Skincare Studio INC

St. John's, Newfoundland and Labrador, A1E1V4, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P1X3, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

Whitby Health Centre Dermatology Trials

Whitby, Ontario, L1P0P9, Canada

Location

Innovaderm Research, Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Related Publications (1)

• 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.

  PMID: 38777187 DERIVED

Study Officials

• Clinical Lead Late-Stage Clinical Development

  Organon and Co

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 29, 2021
• Study Start: December 2, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7); US (12)