Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Organon

Status and phase

Enrolling

Phase 3

Conditions

Plaque Psoriasis

Treatments

Drug: tapinarof cream, 1%

Study type

Interventional

Funder types

Industry

Identifiers

NCT05172726

DMVT-505-3004

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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)