Tapinarof Cream for Plaque Psoriasis

Recruiting at 16 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

560 Participants Needed

Trial Summary

What is the purpose of this trial?

To compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with plaque psoriasis.

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.

What data supports the effectiveness of the drug Tapinarof Cream 1% for treating plaque psoriasis?

Tapinarof Cream 1% has shown promising results in clinical trials, with 35.4% and 40.2% of patients achieving significant improvement compared to 6.0% and 6.3% in the placebo group. Additionally, a high rate of complete disease clearance was observed, with 40.9% of patients achieving clear skin. ^{1 2 3 4 5}

Is Tapinarof Cream 1% safe for human use?

Tapinarof Cream 1% has been shown to be generally safe in humans, with common side effects including mild to moderate folliculitis (inflammation of hair follicles), contact dermatitis (skin irritation), and headache. These side effects were mostly localized to the application site and led to low discontinuation rates in clinical trials. ^{1 3 4 6 7}

What makes Tapinarof Cream unique for treating plaque psoriasis?

Tapinarof Cream 1% is unique because it is a non-steroidal topical treatment that works by activating aryl hydrocarbon receptors, which help regulate the immune response and maintain skin balance. It is applied once daily and has shown significant efficacy in clinical trials, with some patients experiencing complete disease clearance and a remittive effect lasting about four months after stopping the treatment. ^{1 2 3 5 8}

Eligibility Criteria

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.

My doctor rates my condition as mild, moderate, or severe.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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% 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 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]

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, 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

VTAMA® (Tapinarof) Cream* for Plaque Psoriasis. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Tapinarof Cream 1%: First Approval. [2022]

3. Switzerland 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Review of Tapinarof: Novel Topical Treatment for Plaque Psoriasis in Adults. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Review of Topical Tapinarof for the Treatment of Plaque Psoriasis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Tapinarof for the treatment of psoriasis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. [2021]