Tapinarof Cream for Plaque Psoriasis

No longer recruiting at 26 trial locations

Overseen By US Med INFO

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Teva Pharmaceuticals USA

Must not be taking: Biologics, Systemic steroids

Disqualifiers: Unstable psoriasis, Immunosuppression, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of Tapinarof Cream, a topical treatment for plaque psoriasis. Participants will apply either the test product (Tapinarof Cream 1%), a placebo, or a reference product to evaluate its impact on their skin condition. Eligibility requires stable plaque psoriasis for at least six months, affecting 3% to 20% of the body surface area, excluding the face, scalp, groin, palms, and soles. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop using certain medications before joining the trial. Specifically, you must stop using topical anti-psoriatic drugs, topical corticosteroids, and immunosuppressive drugs at least two weeks before starting the trial. Additionally, you should not have used systemic steroids, antibiotics, or other systemic treatments for psoriasis within one month before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Tapinarof Cream 1% is generally safe and effective for people with plaque psoriasis. In studies, many patients noticed improvements in their skin condition. Specifically, 36% and 40% of adults using the cream experienced good results, compared to only 6% who used a placebo (a cream with no active ingredient). This suggests the cream is both effective and safe. While some individuals might experience mild side effects, the cream is comparable to other treatments and has been safely used for similar conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for plaque psoriasis?

Tapinarof Cream is unique because it offers a novel approach to treating plaque psoriasis. Unlike standard treatments like corticosteroids or biologics, tapinarof works by modulating the aryl hydrocarbon receptor (AhR), which plays a role in skin health and immune response. This mechanism can potentially reduce inflammation and improve skin lesions without the side effects commonly associated with steroids. Researchers are excited because this new pathway might offer a safer, effective alternative for managing psoriasis, especially for those who need long-term treatment options.

What evidence suggests that this trial's treatments could be effective for plaque psoriasis?

Research has shown that Tapinarof Cream 1% effectively treats plaque psoriasis. One study found that nearly half of the patients using the cream experienced a 75% or greater improvement in symptoms, compared to about 10% of those using a placebo (a cream with no active ingredients). Another study demonstrated that Tapinarof Cream outperformed a non-active cream in reducing plaque psoriasis severity. In this trial, participants will receive either Tapinarof Cream 1%, VTAMA® (another formulation of Tapinarof Cream), or a placebo cream. These findings suggest that Tapinarof Cream 1% could be a promising option for managing plaque psoriasis symptoms. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with plaque psoriasis. Specific eligibility details are not provided, but typically participants must have a certain severity of psoriasis and be in good general health.

Inclusion Criteria

I have had stable plaque psoriasis for at least 6 months.

My skin condition affects between 3% and 20% of my body, excluding my face, scalp, groins, palms, and soles.

Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria

I do not have allergies to any ingredients in the study treatment.

I have scars or pigmented spots in the areas needing treatment.

I do not have unstable psoriasis types like guttate or pustular in the treatment area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply a thin layer of Tapinarof Cream 1% or placebo once daily to psoriatic affected areas

12 weeks

Regular visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tapinarof Cream 1%

Trial Overview

The study is testing the effectiveness and safety of Tapinarof Cream 1% against VTAMA® (also Tapinarof Cream 1%) and a placebo cream to see if they are clinically equivalent in treating plaque psoriasis.

How Is the Trial Designed?

Group I: Test: Tapinarof Cream 1% Experimental Treatment 1 Intervention

Tapinarof Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days.

Group II: VTAMA® Active Control 1 Intervention

(Tapinarof) Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days.

Group III: Vehicle Product Placebo Group 1 Intervention

Vehicle of the Test Product, Cream, Apply a thin layer once daily to psoriatic affected areas for 84 days.

Tapinarof Cream 1% 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

Who Is Running the Clinical Trial?

Teva Pharmaceuticals USA

Lead Sponsor

Trials

232

Recruited

189,000+

Dr. Eric A. Hughes

Teva Pharmaceuticals USA

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Pharmaceuticals USA

Chief Executive Officer since 2023

BSc in Biochemistry from Imperial College London

Teva Pharmaceuticals, Inc.

Industry Sponsor

Trials

2

Recruited

1,400+

Published Research Related to This Trial

Tapinarof cream 1% is a topical treatment that acts as an aryl hydrocarbon receptor (AhR) agonist, which plays a role in regulating immune responses in the skin, and it has been approved in the USA for treating plaque psoriasis in adults.

The cream is also being studied for its effectiveness in treating atopic dermatitis, indicating its potential as a versatile treatment for various skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tapinarof Cream 1%: First Approval. Keam, SJ.[2022]

Tapinarof, a new topical treatment for plaque psoriasis, has shown significant efficacy in two phase III trials, with 35.4%-40.2% of patients achieving a favorable response compared to only 6.0%-6.3% in the placebo group.

The treatment demonstrated a favorable safety profile over 40 weeks, with common side effects being mild (like folliculitis and contact dermatitis) and no new safety concerns identified, making it a promising alternative to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tapinarof for the treatment of psoriasis. Nogueira, S., Rodrigues, MA., Vender, R., et al.[2023]

In two 12-week phase III clinical trials, 1% tapinarof cream demonstrated significant efficacy in treating plaque psoriasis, with 35.4% and 40.2% of patients achieving clear or almost clear skin by week 12.

Tapinarof, a first-in-class topical treatment approved by the FDA, showed promising long-term results in a 40-week extension trial, with 40.9% of patients achieving complete clearance at least once, indicating its potential as a safe and effective option for managing plaque psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Topical Tapinarof for the Treatment of Plaque Psoriasis. Grossmann, MC., Pixley, JN., Feldman, SR.[2023]

Tapinarof (VTAMA®) 1% cream is an effective new treatment for plaque psoriasis, showing significant improvement in 35.4% to 40.2% of patients compared to only 6.0% to 6.3% in the placebo group over 12 weeks in phase 3 trials.

The mechanism of action involves tapinarof activating aryl hydrocarbon receptors, which help regulate immune response and maintain skin health, although some patients experienced mild adverse effects like folliculitis and headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VTAMA® (Tapinarof) Cream* for Plaque Psoriasis. Gupta, AK., Ravi, SP., Vincent, K., et al.[2022]

Tapinarof cream 1% was found to be well tolerated in 376 healthy adults across four phase 1 trials, showing only a slight potential for very mild cumulative skin irritation after 21 days of daily use.

The cream demonstrated no evidence of sensitization, photosensitization, or phototoxicity, indicating it is a safe option for treating conditions like psoriasis and potentially atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials. Jett, J., McLaughlin, M., Wilson, T., et al.[2022]

Tapinarof cream 1% has been shown to be highly effective in treating plaque psoriasis, achieving complete disease clearance in 40.9% of patients after 52 weeks of treatment, with significant improvements in disease activity and quality of life.

The treatment was well tolerated, with mild to moderate side effects like folliculitis and contact dermatitis, leading to low rates of discontinuation, indicating its safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials. Desai, SR., Stein Gold, L., Cameron, MC., et al.[2023]

Tapinarof, a new topical treatment for plaque psoriasis, was approved by the FDA in May 2022 and has shown proven efficacy and safety in clinical studies, making it a promising option for adults with this condition.

Unlike traditional topical corticosteroids, which can have adverse effects and limitations, tapinarof offers a novel mechanism of action by modulating the aryl hydrocarbon receptor, potentially improving patient care in managing psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Tapinarof: Novel Topical Treatment for Plaque Psoriasis in Adults. Kalabalik-Hoganson, J., Nogid, A., Frey, K.[2023]

Tapinarof 1% cream significantly improved psoriasis severity compared to a vehicle control, with 35.4% and 40.2% of patients achieving a clear or almost clear status after 12 weeks in two phase 3 trials involving 1,025 patients.

While tapinarof was effective, it was associated with local adverse events such as folliculitis and contact dermatitis, indicating the need for further studies to assess its long-term safety and efficacy compared to existing psoriasis treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. Lebwohl, MG., Stein Gold, L., Strober, B., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10539260/

Tapinarof Cream 1% Once Daily for the Treatment of ...

In the PSOARING clinical trials, tapinarof cream 1% QD demonstrated significant efficacy and noticeable improvement in psoriasis disease ...

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vtamahcp.com

vtamahcp.com/plaque-psoriasis/efficacy/

See Clinical Results for VTAMA® (tapinarof) cream, 1%

VTAMA cream delivered significant PASI75 rates as early as week 4 and at week 12, up to 48% of adult patients achieved PASI75 vs ~10% of those using vehicle.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06742957

Study Comparing Tapinarof Cream 1% To VTAMA ® ...

To compare the safety of Test, Reference, and Placebo treatments in patients with Plaque Psoriasis. Patients in this randomized, double-blind, three-arm, ...

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nejm.org

nejm.org/doi/full/10.1056/NEJMoa2103629

Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis

Tapinarof 1% cream once daily was superior to vehicle control in reducing the severity of plaque psoriasis over a period of 12 weeks but was associated with ...

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accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2022/215272Orig1s000MultidisciplineR.pdf

215272Orig1s000 - accessdata.fda.gov

To establish the efficacy of tapinarof cream, 1% in the treatment of plaque psoriasis, the. Applicant submitted the data from two adequate ...

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organon.com

organon.com/news/new-data-show-early-and-consistent-response-to-vtama-tapinarof-cream-1-in-children-aged-2-with-atopic-dermatitis-including-those-with-associated-comorbidities/

New Data Show Early and Consistent Response to VTAMA ...

The new data demonstrate that VTAMA cream provided early and consistent response for children aged 2-17 with atopic dermatitis (AD), with or ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05789576

NCT05789576 | A Study to Investigate Efficacy and Safety ...

A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Region. ClinicalTrials.gov ID NCT05789576.

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va.gov

va.gov/formularyadvisor/DOC_PDF/MON_Tapinarof_VTAMA_Cream_in_Psoriasis_Monograph_Jun_2023.pdf

Tapinarof (VTAMA) Cream in Psoriasis National Drug ...

Tapinarof cream was numerically better than vehicle in patient-reported outcomes (PP-NRS score, PP- NRS-4 response, DLQI total score, and psoriasis symptom ...