What side effects are associated with this type of intervention?

Common treatments for Palmoplantar Pustulosis (PPP) include systemic therapies such as oral retinoids, methotrexate, cyclosporine, and biologics like infliximab and adalimumab. These treatments can have various side effects. Oral retinoids may cause dryness of the skin and mucous membranes, elevated liver enzymes, and lipid abnormalities. Methotrexate can lead to liver toxicity, bone marrow suppression, and gastrointestinal issues. Cyclosporine is associated with nephrotoxicity, hypertension, and increased risk of infections. Biologics like infliximab and adalimumab can cause injection site reactions, increased risk of infections, and potential reactivation of latent tuberculosis. Deucravacitinib, being a selective TYK2 inhibitor, may have a different side effect profile, but further studies are needed to fully understand its safety and efficacy.

What prior FDA approvals exist?

There is limited information on prior FDA approvals specifically for the treatment of Palmoplantar Pustulosis (PPP). However, treatments for PPP often involve biologics and immunomodulatory therapies. Deucravacitinib, a selective TYK2 inhibitor, represents a novel approach in this context. Similar treatments that modulate immune pathways, such as TNF inhibitors, IL-17 inhibitors, and IL-23 inhibitors, have been used for related inflammatory conditions like psoriasis, which shares some pathophysiological features with PPP.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for Palmoplantar Pustulosis patients include the use of hydrocolloid dressings for hand-foot skin reactions induced by kinase inhibitors, which are being studied in a phase 3 trial. Additionally, the combination of topical beta-blockers (timolol) and antibiotic ointments (neomycin/tyrothricin) has shown favorable results in treating drug-induced skin conditions like paronychia and pseudopyogenic granulomas. These treatments could potentially be adapted for PPP management.

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Janus kinase (JAK) inhibitor

Deucravacitinib for Palmoplantar Pustulosis

Phase 4

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate-severe PPP, defined as a ppPASI > 12

Dermatologist confirmed diagnosis of PPP for at least 6 months

Must not have

Major surgery within 4 weeks of baseline visit

Participants with other immune-mediated conditions requiring concurrent systemic immunosuppressant treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16, 24

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial tests a pill called deucravacitinib in adults with severe PPP who haven't responded to other treatments. The medication aims to reduce inflammation and calm the immune system, improving symptoms like redness and swelling. Deucravacitinib has shown efficacy in treating moderate to severe plaque psoriasis.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for Deucravacitinib in this trial aren't listed, common ones may include headaches, nausea, upper respiratory infections, high blood pressure, and potential liver enzyme abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My palmoplantar pustulosis is moderate to severe.

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

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

Select...

Creams or ointments didn't work for my condition, and I need stronger treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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I am taking medication to suppress my immune system due to another immune condition.

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I have not had any cancer, except for treated non-melanoma skin cancer, in the last 5 years.

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I haven't had a serious infection or needed antibiotics in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16, 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16, 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16, 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in EQ-5D VAS

Change from baseline in ppPASI

Change from baseline in the Dermatology Quality Life Index (DLQI)

+4 more

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990

25%

COVID-19

13%

Pneumonia

13%

Nasopharyngitis

Upper respiratory tract infection

Cough

Pyrexia

Mouth ulceration

Urinary tract infection

Small intestinal obstruction

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

CROHN'S DISEASE

ULCERATIVE COLITIS

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with Palmoplantar pustulosisExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

2021

Completed Phase 4

~160

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Deucravacitinib is a selective TYK2 inhibitor that works by blocking the TYK2 enzyme, which is involved in the signaling pathways of several cytokines implicated in inflammatory processes, such as IL-23, IL-12, and Type I interferons. This inhibition reduces the inflammatory response, which is crucial in managing Palmoplantar Pustulosis (PPP), a condition characterized by recurrent pustules and inflammation on the palms and soles. Understanding the mechanism of action is important for PPP patients as it helps in selecting targeted therapies that can effectively reduce symptoms and improve quality of life by addressing the underlying inflammatory pathways.

Effect of treatment with a colloidal oatmeal lotion on the acneform eruption induced by epidermal growth factor receptor and multiple tyrosine-kinase inhibitors.