Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Launched by ORGANON AND CO · Dec 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new cream called tapinarof, which is being tested for treating plaque psoriasis in children and teenagers aged 2 to 17 years. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin, and this study aims to see how well the cream works in managing this condition. The trial is open to both boys and girls who have had stable psoriasis for at least three months and have a certain level of skin involvement.

Participants in the trial will use the tapinarof cream and will be monitored for its effectiveness and safety. To be eligible, children should have a significant area of their skin affected by psoriasis, and they must not have other forms of psoriasis or any serious infections. Parents or guardians will need to provide consent for their child to participate. It's important to know that anyone who is pregnant or has certain health issues may not qualify for the study. If you think your child might be eligible, this could be a great opportunity to help find new treatments for plaque psoriasis.

Gender

ALL

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)