Tapinarof Cream for Plaque Psoriasis

Not currently recruiting at 56 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called tapinarof for treating plaque psoriasis, a skin condition that causes itchy, scaly patches. The goal is to evaluate the cream's effectiveness in children and teens with stable plaque psoriasis for at least 3 months. Participants should have psoriasis covering at least 3% of their body and must not have other types of psoriasis or infections on their patches. This trial might be a good fit for those dealing with these symptoms. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 there any evidence suggesting that tapinarof cream is likely to be safe for humans?

Research shows that tapinarof cream is generally easy to use without problems. In earlier studies with adults who have plaque psoriasis, the side effects of tapinarof cream matched those seen in past research, indicating no unexpected side effects. Participants in these studies applied tapinarof cream 1% once a day, and it was well-tolerated.

The FDA has already approved tapinarof cream for other uses, meaning it has passed strict safety checks. While this doesn't guarantee safety for everyone, it does provide some reassurance about its overall safety. If considering joining this trial, existing data suggests that serious side effects are unlikely. ^{1 2 3 4 5}

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

Tapinarof cream is unique because it offers a new approach to treating plaque psoriasis by using a novel active ingredient derived from natural sources. Unlike traditional treatments such as corticosteroids or biologics, tapinarof works by modulating the aryl hydrocarbon receptor (AhR) pathway, which plays a key role in skin health and immune response. Researchers are excited about this treatment because it not only targets the inflammation and skin cell growth associated with psoriasis but also has the potential for fewer side effects, making it an attractive option for long-term management of the condition.

What evidence suggests that tapinarof cream might be an effective treatment for plaque psoriasis?

Research has shown that tapinarof cream effectively treats plaque psoriasis. In clinical studies, applying tapinarof cream 1% once daily significantly improved psoriasis symptoms compared to a placebo cream. Six times more patients using tapinarof achieved clear or almost clear skin after just four weeks. Patients also reported reduced itching, a common psoriasis symptom. Overall, tapinarof cream significantly reduced the severity of plaque psoriasis in these studies. ^{1 2 4 5 6}

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, 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 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]

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 (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]

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]

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 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

1. 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 ...

2. vtamahcp.com vtamahcp.com/plaque-psoriasis/efficacy/

See Clinical Results for VTAMA® (tapinarof) cream, 1% 6x more adult patients with plaque psoriasis who received VTAMA cream achieved treatment success* vs vehicle, with significant results as early as week 4.2,5-7.

3. 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30612986/

Phase 2, randomized dose-finding study of tapinarof ... Primary endpoint included PGA of 0 or 1 at week 12 and a 2-grade improvement from baseline. Additional analyses included assessment of ≥75% improvement of ...

5. jaad.org jaad.org/article/S0190-9622(24)00755-2/fulltext

Tapinarof cream 1% once daily: Significant efficacy in the ... Greater improvements in itch were reported in the tapinarof compared with vehicle groups, with a statistically significant improvement in PP-NRS ...

6. 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.