Children and adolescents (aged 2 to 17) may qualify for a research trial testing an investigational topical treatment for Plaque Psoriasis. Eligible participants must have a diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the Baseline visit. Individuals must also have psoriasis on 3% or more of their body surface area (BSA).
Participants will receive investigational topical treatment (active study drug). Investigational medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 17 weeks (for those completing the primary treatment phase only) and involve about 7 visits to the study centre, plus 2 phone visits. For those who choose to participate in the optional long-term extension phase, study participation will last about 57 weeks and involve about 17 visits to the study centre, plus 2 phone visits.
Calgary - Dermatology Research Institute
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Last Update Posted: September 24, 2023
NCT05172726
Dermavant Sciences, Inc.
Brief Summary:
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
Condition or Disease:
Plaque Psoriasis
Intervention/Treatment:
Drug: tapinarof cream, 1%Phase:
Phase 3
Ages Eligible for Study:
2 Years and 17 Years (Child)
Sexes Eligible for Study:
All
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)
Terms and Conditions – ClinicalTrials.gov
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