Clinical trial NCT05172726: Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
Official title: A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis
pediatric
phase 3
topical
tapinarof
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Screening up to Week 53
measure: Number of subjects with clinically significant laboratory test abnormalities
timeFrame: Screening up to Week 53
measure: Number of subjects with clinically significant vital signs abnormalities
timeFrame: Screening up to Week 53
measure: Investigator-Assessed Local Tolerability Scale (LTS) Scores
timeFrame: Baseline up to Week 52
measure: Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.
timeFrame: Week 4 and Week 12
measure: Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.
timeFrame: Week 4 and Week 12
measure: Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.
timeFrame: Week 4 and Week 12
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Clinical Site
state: Arkansas
city: Fountain Valley
country: United States
facility: Clinical Site
state: California
city: Rancho Santa Margarita
country: United States
facility: Clinical Site
state: California
city: Clearwater
country: United States
facility: Clinical Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Site
state: Florida
city: Chicago
country: United States
facility: Clinical Site
state: Illinois
city: Indianapolis
country: United States
facility: Clinical Site
state: Indiana
city: West Lafayette
country: United States
facility: Clinical Site
state: Indiana
city: Fairborn
country: United States
facility: Clinical Site
state: Ohio
city: Portland
country: United States
facility: Clinical Site
state: Oregon
city: Spokane
country: United States
facility: Clinical Site
state: Washington
city: Spokane
country: United States
facility: Clinical Site
state: Washington
city: Calgary
country: Canada
facility: Clinical Site
state: Alberta
city: Edmonton
country: Canada
facility: Clinical Site
state: Alberta
city: Saint John's
country: Canada
facility: Clinical Site
state: Newfoundland and Labrador
city: Markham
country: Canada
facility: Clinical Site
state: Ontario
city: Oshawa
country: Canada
facility: Clinical Trials
state: Ontario
city: Waterloo
country: Canada
facility: Clinical Site
state: Ontario
city: Montréal
country: Canada
facility: Clinical Site
state: Quebec
Study officials:
affiliation: Organon and Co
name: Clinical Lead Late-Stage Clinical Development
role: STUDY_DIRECTOR
References: