Tapinarof Cream for Plaque Psoriasis

Recruiting at 35 trial locations

Overseen By Clinical Lead Late-Stage Clinical Development

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Organon and Co

Disqualifiers: Infection, Immunocompromised, Liver disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

100 Participants Needed

What You Need to Know Before You Apply

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. ^{1 2 3 4 5}

How 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. ^{1 3 5 6 7}

Who Is on the Research Team?

Clinical Lead Late-Stage Clinical Development

Principal Investigator

Organon and Co

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Tapinarof

Trial Overview 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.

How Is the Trial Designed?

Group I: Open Label Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Organon and Co

Lead Sponsor

Trials

492

Recruited

1,733,000+

Juan Camilo Arjona Ferreira

Organon and Co

Chief Medical Officer since 2023

MD

Kevin Ali

Organon and Co

Chief Executive Officer since 2021

MBA from Santa Clara University, BA from the University of California, Berkeley

Dermavant Sciences, Inc.

Lead Sponsor

Trials

9

Recruited

1,800+

Published Research Related to This Trial

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, 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 (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&#174; (Tapinarof) Cream* for Plaque Psoriasis. Gupta, AK., Ravi, SP., Vincent, K., et al.[2022]

Benvitimod (Tapinarof) effectively reduces the excessive proliferation of keratinocytes in psoriasis by inhibiting the MCM6 protein, which is crucial for cell replication, as demonstrated in both in vitro studies with HaCaT cells and in vivo studies using an imiquimod-induced mouse model.

The mechanism of action involves the inhibition of the JAK/STAT3 signaling pathway, specifically by reducing the activation of p-JAK1 and p-JAK2, leading to decreased STAT3 activation and ultimately lowering keratinocyte proliferation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benvitimod inhibits MCM6-meditated proliferation of keratinocytes by regulating the JAK/STAT3 pathway. Cai, Z., Zeng, Y., Shi, X., et al.[2023]

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 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]

In a phase 2b study involving adults with plaque psoriasis, tapinarof cream (0.5% and 1%) showed significant improvements in psoriasis severity compared to a vehicle, with up to 92% of patients achieving a 50% reduction in severity after 12 weeks.

Most side effects from tapinarof were mild or moderate, suggesting a favorable safety profile, and the treatment demonstrated early efficacy, with significant results seen as early as week 2 and maintained through week 16.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes. Stein Gold, L., Bhatia, N., Tallman, AM., et al.[2021]

Citations

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

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

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

Tapinarof for the treatment of psoriasis. [2023]

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

VTAMA&#174; (Tapinarof) Cream* for Plaque Psoriasis. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Benvitimod inhibits MCM6-meditated proliferation of keratinocytes by regulating the JAK/STAT3 pathway. [2023]

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

Tapinarof Cream 1%: First Approval. [2022]

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

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

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

A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes. [2021]