A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Organon and Co
- Enrollment
- 58
- Locations
- 36
- Primary Endpoint
- Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Open Label
Intervention: tapinarof cream, 1% (Drug)
Outcomes
Primary Outcomes
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
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.
Number of subjects with clinically significant laboratory test abnormalities
Time Frame: Screening up to Week 53
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.
Number of subjects with clinically significant vital signs abnormalities
Time Frame: Screening up to Week 53
Secondary Outcomes
- 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)
- Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.(Week 4 and Week 12)
- Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.(Week 4 and Week 12)