Treatment of plaque psoriasis in children using tapinarof cream
A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
This study is testing if a new cream can help children aged 2 to 17 with plaque psoriasis feel better over a 12-week treatment period.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Dermavant Sciences, Inc. Industry-sponsored |
| Locations | 19 sites (Rogers, Arkansas and 18 other locations) |
| Trial ID | NCT05172726 on ClinicalTrials.gov |
What this trial studies
This open-label, multi-center Phase 3 study evaluates the efficacy of tapinarof cream, 1%, in pediatric patients aged 2 to 17 years with chronic plaque psoriasis. The study consists of a 12-week primary treatment phase followed by an optional 40-week long-term extension phase, where all eligible subjects will receive the treatment once daily. Participants who opt out of the extension will have a follow-up visit approximately one week after the primary phase ends.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 17 years with a clinical diagnosis of chronic plaque psoriasis covering at least 3% of their body surface area.
Not a fit: Patients with psoriasis types other than the plaque variant or those with active infections in psoriatic lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of plaque psoriasis in pediatric patients.
How similar studies have performed: Other studies have shown promising results with topical treatments for plaque psoriasis, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rogers, Arkansas and 18 other locations
- Dermavant Clinical Site — Rogers, Arkansas, United States (Recruiting)
- Dermavant Clinical Site — Fountain Valley, California, United States (Recruiting)
- Dermavant Clinical Site — Rancho Santa Margarita, California, United States (Recruiting)
- Dermavant Clinical Site — Clearwater, Florida, United States (Recruiting)
- Dermavant Clinical Site — Miami Lakes, Florida, United States (Recruiting)
- Dermavant Clinical Site — Chicago, Illinois, United States (Recruiting)
- Dermavant Clinical Site — Indianapolis, Indiana, United States (Recruiting)
- Dermavant Clinical Site — West Lafayette, Indiana, United States (Recruiting)
- Dermavant Clinical Site — Fairborn, Ohio, United States (Recruiting)
- Dermavant Clinical Site — Portland, Oregon, United States (Recruiting)
- Dermavant Clinical Site — Spokane, Washington, United States (Recruiting)
- Dermavant Clinical Site — Spokane, Washington, United States (Recruiting)
- Dermavant Clinical Site — Calgary, Alberta, Canada (Recruiting)
- Dermavant Clinical Site — Edmonton, Alberta, Canada (Recruiting)
- Dermavant Clinical Site — Saint John's, Newfoundland and Labrador, Canada (Recruiting)
- Dermavant Clinical Site — Markham, Ontario, Canada (Recruiting)
- Dermavant Clinical Trials — Oshawa, Ontario, Canada (Recruiting)
- Dermavant Clinical Site — Waterloo, Ontario, Canada (Recruiting)
- Dermavant Clinical Site — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Philip Brown, MD, JD
- Email: dermavantclinicaltrials@dermavant.com
- Phone: 480-666-0844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.