Tapinarof Cream for Plaque Psoriasis
Recruiting in Palo Alto (17 mi)
+17 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Dermavant Sciences, Inc.
Disqualifiers: Infection, Immunocompromised, Liver disease, Cancer, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
Will I have to stop taking my current medications?
The trial information does not clearly state if you need to stop taking your current medications. However, it mentions that the use of any prohibited medication is not allowed during the study, so you may need to discuss your current medications with the study team.
Is Tapinarof cream safe for human use?
Tapinarof cream has been shown to be generally safe for human use, with common side effects including folliculitis (inflammation of hair follicles), contact dermatitis (skin irritation), headache, and upper respiratory tract infection. These findings are based on clinical trials for plaque psoriasis, and no new safety concerns were identified in extended studies.
12345How is the drug Tapinarof cream unique for treating plaque psoriasis?
Tapinarof cream is unique because it is a topical treatment that works by activating aryl hydrocarbon receptors, which help regulate the immune response and maintain skin health. Unlike traditional treatments like corticosteroids, it offers a novel mechanism of action with promising results in clinical trials.
13567Eligibility Criteria
This trial is for children and teens aged 2 to 17 with chronic plaque psoriasis covering at least 3% of their body. They must have had stable disease for the past three months, not be pregnant or immunocompromised, and have normal liver function tests. Girls who can get pregnant must use birth control.Inclusion Criteria
I am between 2 and 17 years old with stable chronic plaque psoriasis for at least 3 months.
My psoriasis covers 3% or more of my body.
I, or my legal guardian, can sign the consent form.
+3 more
Exclusion Criteria
I haven't used any forbidden medications or procedures recently.
Pregnant or lactating females
I have previously participated in a study involving tapinarof.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive tapinarof cream, 1% once daily for 12 weeks
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 week
Long-term extension (optional)
Participants may opt into continuation of treatment with tapinarof cream for an additional 40 weeks
40 weeks
Participant Groups
The study is testing tapinarof cream, a medication applied to the skin, in kids with plaque psoriasis. It's an open-label Phase 3 trial which means everyone knows they're getting tapinarof and it's being tested for safety and effectiveness.
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Tapinarof is already approved in United States for the following indications:
🇺🇸 Approved in United States as Vtama for:
- Plaque psoriasis in adults
- Atopic dermatitis in adults and pediatric patients 2 years of age and older
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dermavant Clinical SiteWest Lafayette, IN
Dermavant Clinical SitePortland, OR
Dermavant Clinical SiteRancho Santa Margarita, CA
Dermavant Clinical SiteChicago, IL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Dermavant Sciences, Inc.Lead Sponsor
References
A Review of Tapinarof: Novel Topical Treatment for Plaque Psoriasis in Adults. [2023]Psoriasis is a chronic, immune-mediated, multisystem, inflammatory dermatological condition that is persistent and relapsing. Topical treatments are first line agents for mild to moderate plaque psoriasis. With proven efficacy and safety, topical corticosteroids are often used, although adverse effects and limitations for use exist. Tapinarof (Vtama®), a novel topical aryl hydrocarbon receptor modulating drug, was approved by the US Food and Drug Administration for the treatment of plaque psoriasis in adults in May 2022. A literature search of PubMed, MEDLINE, and ClinicalTrials.gov was conducted using the following keywords: tapinarof, psoriasis, GSK2894512. Articles published before January 2023 were included in this review. This review describes the preclinical and clinical studies demonstrating the efficacy and safety of tapinarof, its place in therapy, and relevance to patient care. Kalabalik-Hoganson J, Nogid A, Frey K. A review of tapinarof: novel topical treatment for plaque psoriasis in adults. J Drugs Dermatol. 2023;22(8):761-765. doi:10.36849/JDD.7481.
Tapinarof for the treatment of psoriasis. [2023]Although topical drugs are the mainstay of treatment for patients with mild-to-moderate psoriasis, the developments observed in this field in the last two decades have been limited. The most commonly used drugs are still vitamin D analogues and corticosteroids, both with several limitations. The aryl hydrocarbon receptor (AhR) plays a role in the pathogenesis of psoriasis, and tapinarof, a novel, first-in-class, small molecule topical therapeutic AhR-modulating agent has been recently approved by the FDA for the topical treatment of plaque psoriasis in adults. Two large, 12-week, phase III trials, PSOARING 1 and 2, showed that 35.4%-40.2% of patients in the tapinarof 1% cream arm achieved the primary endpoint (Physician's Global Assessment [PGA] score of 0 or 1 and a decrease of ≥2-5 points at week 12) compared with 6.0%-6.3% for vehicle arm, respectively. The most common adverse effects were folliculitis, contact dermatitis, headache and pruritus. In the open label, 40-week, extension trial, PSOARING 3, the efficacy and safety results were similar, with 40.9% of patients achieving a PGA = 0 at least one time during the trial and 58.2% of patients with PGA≥2 achieved PGA = 0/1 at least once during the trial, without tachyphylaxis. There were no new safety signals, with most frequent adverse events being folliculitis, contact dermatitis, and upper respiratory tract infection. Tapinarof 1% cream has shown to be effective and to have a favorable safety profile in the treatment of psoriatic patients, representing an alternative to the current therapeutic options, increasing our armamentarium in the topical treatment of psoriasis.
VTAMA® (Tapinarof) Cream* for Plaque Psoriasis. [2022]VTAMA® (Tapinarof) 1% cream is a newly approved topical agent for treating plaque psoriasis. The active ingredient, tapinarof, binds to and activates aryl hydrocarbon receptors that positively regulate immune response and skin homeostasis. Tapinarof has presented promising results in two identical phase 3 randomized, double-blind, vehicle-controlled trials, where the primary efficacy end points were observed in 35.4% and 40.2% of patients in the tapinarof group compared to 6.0% and 6.3% of patients in the vehicle group. Tapinarof was applied once daily to affected psoriasis lesions for 12 weeks. Adverse events associated with tapinarof application were folliculitis, contact dermatitis, and headache. (SKINmed. 2022;20:298-300).
Benvitimod inhibits MCM6-meditated proliferation of keratinocytes by regulating the JAK/STAT3 pathway. [2023]Benvitimod (Tapinarof), as a small-molecule topical therapeutical aryl hydrocarbon receptor (AHR)-modulating agent, is in clinical development for treating psoriasis and atopic dermatitis. Benvitimod reduces proinflammatory cytokines in psoriasis by specifically binding and activation of AHR. However, whether benvitimod can inhibit keratinocyte proliferation remains unclear. Minichromosome maintenance protein 6 (MCM6) is a key element of the prereplication complex (pre-RC) assembly which is one of the essential steps in the initiation of DNA replication for cell proliferation.
Tapinarof Cream 1%: First Approval. [2022]Tapinarof cream 1% (VTAMA®) is an aryl hydrocarbon receptor (AhR) agonist that is being developed by Dermavant Sciences Inc. (a subsidiary of Roivant Sciences Inc.) as a once-daily topical treatment for plaque psoriasis and atopic dermatitis. AhR is a ligand-dependent transcription factor that has a role in immune-mediated skin responses. In May 2022, tapinarof cream 1% was approved in the USA for the topical treatment of plaque psoriasis in adults. Tapinarof cream 1% is also being investigated for the treatment of atopic dermatitis. This article summarizes the milestones in the development of tapinarof cream 1% leading to this first approval for the topical treatment of plaque psoriasis.
Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. [2021]Tapinarof cream is a topical aryl hydrocarbon receptor-modulating agent under investigation for the treatment of psoriasis. Tapinarof modulates the expression of interleukin-17 and the skin-barrier proteins filaggrin and loricrin.
A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes. [2021]Tapinarof cream is a topical therapeutic aryl hydrocarbon receptor modulating agent under investigation for treatment of psoriasis and atopic dermatitis.