Deucravacitinib for Palmoplantar Pustulosis

Recruiting at 1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Brigham and Women's Hospital

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

Disqualifiers: Infections, Cancer, Surgery, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

Is Deucravacitinib safe for human use?

Deucravacitinib, also known as Sotyktu, has been studied for safety in treating conditions like psoriasis. Common side effects include upper respiratory infections, increased blood enzyme levels, herpes simplex infections, mouth ulcers, and acne. Long-term use up to 52 weeks did not show an increase in adverse reactions, suggesting a favorable safety profile compared to other similar treatments. ^{1 2 3 4 5}

How is the drug Deucravacitinib unique for treating palmoplantar pustulosis?

Deucravacitinib is unique because it targets a specific pathway involved in inflammation, which may offer a novel approach compared to other treatments like Apremilast or PUVA therapy, which have limited data and effectiveness for palmoplantar pustulosis. ^{6 7 8 9 10}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Deucravacitinib (Janus kinase (JAK) inhibitor)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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 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]

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 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 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]

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 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]

References

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

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]

3. England 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. [2023]

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

Deucravacitinib: First Approval. [2022]

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

Effectiveness and Safety of Deucravacitinib for the Management of Psoriasis: A Review of the Current Literature. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Apremilast monotherapy for palmoplantar pustulosis: Report of three cases. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Suppression of palmoplantar pustulosis symptoms with oral 8-methoxypsoralen and high-intensity UVA irradiation. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Ustekinumab in the treatment of palmoplantar pustular psoriasis - a case series of nine patients. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

[Apremilast in the treatment of palmoplantar pustulosis : A case series]. [2021]

10. Switzerland 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. [2023]