Deucravacitinib for Palmoplantar Pustulosis

No longer recruiting at 1 trial location

Overseen By Alex Gionfriddo

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Must not be taking: Biologics, Steroids, Retinoids, others

Disqualifiers: Infections, Cancer, Surgery, others

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called deucravacitinib for people with palmoplantar pustulosis (PPP), a skin condition that causes pus-filled blisters on the hands and feet. The trial aims to evaluate the effectiveness of deucravacitinib when taken daily for 24 weeks. Participants will visit the study site every four weeks to monitor progress. The trial seeks individuals with a dermatologist-confirmed diagnosis of moderate to severe PPP for at least six months who haven't had success with topical treatments. As a Phase 4 trial, deucravacitinib is already FDA-approved and proven effective, and this research helps determine how it benefits more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current topical and systemic treatments for PPP, except for over-the-counter moisturizers. There are specific timeframes for stopping certain medications before starting the trial.

What is the safety track record for deucravacitinib?

Previous studies have shown deucravacitinib to be safe for patients. Research examined its safety in treating refractory palmoplantar pustulosis, a persistent skin condition. Most patients experienced mild side effects, such as headaches or mild stomach issues, while serious side effects were rare.

Deucravacitinib is a pill that blocks a specific protein causing inflammation. Its approval for other conditions suggests it is generally safe. Prospective trial participants may find this information reassuring regarding the treatment's safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for palmoplantar pustulosis, which often include topical steroids or phototherapy, deucravacitinib acts on a different level by targeting the TYK2 enzyme. This enzyme plays a key role in the inflammatory process, so inhibiting it can potentially reduce inflammation more effectively. Researchers are excited about deucravacitinib because it offers a novel mechanism of action that could lead to better outcomes for patients who haven't responded well to existing therapies. Plus, its oral administration makes it a more convenient option compared to treatments like phototherapy.

What evidence suggests that deucravacitinib might be an effective treatment for palmoplantar pustulosis?

Research has shown that deucravacitinib, an oral medication, may help treat palmoplantar pustulosis (PPP). This drug blocks TYK2, an enzyme that causes inflammation. Studies suggest that deucravacitinib can reduce symptoms in people with PPP. Although it is already approved for treating plaque psoriasis, early research indicates it might also be effective for PPP. Participants in this trial will receive deucravacitinib, and patients in earlier trials experienced improvements, making this medication a hopeful option for those with PPP. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with a dermatologist-confirmed diagnosis of Palmoplantar Pustulosis (PPP) for at least 6 months, who have not seen results from topical treatments and are candidates for systemic or phototherapy. Participants must have moderate to severe PPP and be willing to stop current PPP treatments except OTC emollients.

Inclusion Criteria

My palmoplantar pustulosis is moderate to severe.

I have been diagnosed with PPP by a dermatologist for at least 6 months.

I am willing to stop my current skin treatments, except for over-the-counter moisturizers.

Exclusion Criteria

I have not had major surgery in the last 4 weeks.

Individuals who are incarcerated or compulsory detained

You have very low white blood cell or platelet counts, or low hemoglobin levels, or high liver enzyme levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deucravacitinib 6 mg daily for 24 weeks

24 weeks

Study visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview

The trial is testing Deucravacitinib, taken daily at a dose of 6 mg for 24 weeks by patients with PPP. The study involves regular visits every four weeks and aims to see how effective this treatment is in managing the condition.

How Is the Trial Designed?

Group I: Subjects with Palmoplantar pustulosis Experimental Treatment 1 Intervention

All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks.

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Apremilast, a phosphodiesterase 4 inhibitor, shows potential as a beneficial treatment for palmoplantar pustulosis, based on three case reports and previous studies.

Currently, there is limited high-quality data on effective treatments for palmoplantar pustulosis, making apremilast a promising option for some patients with this chronic skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast monotherapy for palmoplantar pustulosis: Report of three cases. Marovt, M., Marko, PB.[2023]

In a case series of nine patients with palmoplantar pustular psoriasis, treatment with ustekinumab led to an average improvement of 71.6% in the severity of the condition after 24 weeks, with four patients achieving a 75% improvement.

Ustekinumab was generally well-tolerated, with only mild side effects such as local injection site reactions and infections, indicating its potential as a safe treatment option for this challenging skin disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ustekinumab in the treatment of palmoplantar pustular psoriasis - a case series of nine patients. Buder, V., Herberger, K., Jacobi, A., et al.[2018]

Deucravacitinib (SOTYKTUTM) is an effective oral treatment for moderate to severe plaque psoriasis, with up to 58.4% of patients showing symptom improvement by week 16 in phase 3 trials involving 840 participants.

The drug has a favorable safety profile, with common side effects like upper respiratory infections and herpes simplex infections occurring at manageable rates, and its selectivity may enhance long-term safety compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. Gupta, AK., Wang, T., Vincent, K., et al.[2023]

In a case series of 8 patients with palmoplantar pustulosis, treatment with the phosphodiesterase-4 inhibitor apremilast showed a positive clinical response as measured by the Investigator's Global Assessment (IGA) score over several months.

Apremilast was found to be a safe and effective treatment option for palmoplantar pustulosis, a condition that typically has limited therapy options and a high relapse rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Apremilast in the treatment of palmoplantar pustulosis : A case series]. Frischhut, N., Ratzinger, G.[2021]

In a study of 9 patients with palmoplantar pustulosis, those treated with oral 8-methoxypsoralen and high-intensity UVA irradiation (PUVA) showed significant improvement, with 4 out of 5 patients achieving good or excellent clearing after 20 treatments.

The results suggest that systemic PUVA is more effective than topical PUVA for this condition, likely due to better skin absorption of the medication and sustained photosensitivity, highlighting the importance of treatment method in patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suppression of palmoplantar pustulosis symptoms with oral 8-methoxypsoralen and high-intensity UVA irradiation. Paul, R., Jansén, CT.[2019]

In a phase IIb trial involving 152 patients with moderate-to-severe palmoplantar pustulosis, spesolimab did not meet the primary efficacy endpoint of significantly improving the Palmoplantar Pustular Area and Severity Index compared to placebo.

However, spesolimab showed potential benefits in secondary endpoints, particularly in non-Asian patients, with a higher percentage achieving a Palmoplantar Pustular Physician's Global Assessment score of 0/1 at week 16, indicating some effectiveness despite the primary endpoint not being met.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spesolimab Efficacy and Safety in Patients with Moderate-to-Severe Palmoplantar Pustulosis: A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Phase IIb, Dose-Finding Study. Burden, AD., Bissonnette, R., Navarini, AA., et al.[2023]

In a phase 3 trial involving 66 Japanese patients with moderate to severe plaque psoriasis, deucravacitinib showed significantly higher efficacy compared to placebo and apremilast, with 78.1% of patients achieving a ≥75% reduction in PASI score at Week 16.

The safety profile of deucravacitinib was comparable to that of placebo and apremilast, with similar incidence rates of adverse events, and the most common side effect being nasopharyngitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial. Imafuku, S., Tada, Y., Hippeli, L., et al.[2023]

Deucravacitinib is an oral small molecule that selectively inhibits Tyrosine Kinase 2, showing promise as a new treatment option for managing moderate-to-severe psoriasis, especially for patients who cannot use conventional systemic treatments due to contraindications or adverse events.

The review highlights the need for new therapies like deucravacitinib to improve treatment personalization and maintain long-term effectiveness in psoriasis management, addressing the limitations of existing biological drugs and small molecules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Deucravacitinib for the Management of Psoriasis: A Review of the Current Literature. Potestio, L., Ruggiero, A., Fabbrocini, G., et al.[2023]

Deucravacitinib, a selective tyrosine kinase 2 inhibitor, was found to be safe and well tolerated in a study involving 40 healthy Chinese subjects, with no serious adverse events reported.

The drug showed rapid absorption and a dose-dependent increase in systemic exposure, indicating that it effectively reaches the bloodstream and maintains consistent pharmacokinetics across different doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. Jing, S., Lin, Y., Dockens, R., et al.[2023]

Deucravacitinib is a first-in-class oral TYK2 inhibitor that works by stabilizing an inhibitory interaction within the TYK2 enzyme, which is important for treating various immune-mediated diseases.

It received its first approval in the USA on September 9, 2022, for adults with moderate-to-severe plaque psoriasis, and has since been approved in Japan for multiple forms of psoriasis, indicating its efficacy and safety in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. Hoy, SM.[2022]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666328725001269

Deucravacitinib for the treatment of moderate-to-severe ...

Deucravacitinib for the treatment of moderate-to-severe palmoplantar pustulosis: results from an early-terminated open-label trial. Author ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39255968/

Exploring the effect of deucravacitinib in patients with ...

We evaluated the efficacy and safety of deucravacitinib, a novel oral selective allosteric inhibitor of tyrosine kinase 2 (TYK2), in treating refractory PPPP.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07000630

Study Details | NCT07000630 | Efficacy and Tolerability of ...

The goal of this clinical trial is to investigate the efficacy and safety of Deucravacitinib in patients with moderate-to-severe palmoplantar pustulosis.

4.

tandfonline.com

tandfonline.com/doi/full/10.1080/09546634.2024.2399220

Exploring the effect of deucravacitinib in patients with ...

In summary, deucravacitinib appears to bear physiopathological potential for an effective treatment alternative in treating PPPP patients.

5.

rally.massgeneralbrigham.org

rally.massgeneralbrigham.org/study/deucravacitinib_for_ppp

Rally | Deucravacitinib for the Treatment of Palmoplantar ...

Deucravacitnib is a new oral medication FDA approved for plaque psoriasis. We are doing a study to learn if the medication will also be effective in treating ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06042920

NCT06042920 | A Study to Evaluate Effectiveness and ...

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital ...

7.

bmsclinicaltrials.com

bmsclinicaltrials.com/us/en/clinical-trials/NCT06042920

Trial ID IM011-1112 | NCT06042920 - BMS Clinical Trials

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital ...

8.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/1346-8138.17744

Deucravacitinib, an Oral, Selective, Allosteric Tyrosine ...

Scalp, fingernail, and palmoplantar outcomes were as observed (i.e., no data imputation was performed). ... Safety outcomes in patients with ...