Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects (NCT05172726) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
United States58 participantsStarted 2021-12-02
Plain-language summary
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
Who can participate
Age range2 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Histor…
What they're measuring
1
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Screening up to Week 53
2
Number of subjects with clinically significant laboratory test abnormalities
Timeframe: Screening up to Week 53
3
Number of subjects with clinically significant vital signs abnormalities
Timeframe: Screening up to Week 53
4
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Timeframe: Baseline up to Week 52
5
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)