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Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Study Purpose

A prospective, single-arm, open-label trial of deucravacitinib 6 mg daily in patients with PPP. All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - • Adults aged 18 years of age and older.
  • - Dermatologist confirmed diagnosis of PPP for at least 6 months.
  • - Moderate-severe PPP, defined as a ppPASI > 12.
  • - Inadequate response to topical therapy and a candidate for systemic or phototherapy.
  • - Willing to discontinue current topical and/or systemic PPP treatments, except for OTC emollients.

Exclusion Criteria:

  • - • Participants with other immune-mediated conditions requiring concurrent systemic immunosuppressant treatments.
  • - Current/recent administration of PPP-specific medications including: - Rituximab within 6 months of the baseline visit.
  • - Biologics within 12 weeks of baseline visit.
  • - Systemic steroids, oral immunosuppressants (azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, tacrolimus), oral retinoids (acitretin, isotretinoin), apremilast, or dapsone within 4 weeks of baseline visit.
  • - Phototherapy within 4 weeks of baseline visit.
  • - Prescription topical medications (including calcineurin inhibitors, crisaborole, retinoids, steroids, tar, vitamin D analogs) within 2 weeks of baseline visit.
  • - History of active infection and/or febrile illness within 7 days; or infection requiring antibiotic treatment within 30 days; or serious infection requiring hospitalization and/or IV antibiotics within 90 days.
  • - Evidence of other infection including: - Active or untreated latent tuberculosis, defined as radiographic or laboratory evidence of active TB or positive quantiferon or PPD, unless the subject has completed the recommended treatment.
  • - Human immunodeficiency virus infection (positive HIV antibody) - Active hepatitis B.
  • - Active hepatitis C.
  • - Evidence of clinically significant laboratory abnormality including: - Absolute WBC count < 3000/mm3.
  • - Platelet count < 100,000/mm3.
  • - Hemoglobin < 9.0 g/dl.
  • - ALT or AST > 3 times the upper limit of normal.
  • - History of cancer within the past 5 years, excluding treated non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) - Other uncontrolled chronic medical condition that may interfere with a patient's ability to participate in the clinical trial.
  • - Major surgery within 4 weeks of baseline visit.
  • - Receipt of live vaccine within 8 weeks of baseline visit.
  • - Pregnant or breastfeeding individuals.
  • - Inability to comply with any of the study procedures.
- Individuals who are incarcerated or compulsory detained

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05710185
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Brigham and Women's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Palmoplantar Pustulosis
Additional Details

Objectives: 1. Evaluate the efficacy of deucravacitinib in adults with PPP. 2. Evaluate the impact of deucravacitinib on quality of life in adults with PPP. 3. Evaluate the safety of deucravacitinib Primary Endpoint: • Proportion of participants who achieve a ppPASI-50 response, or at least 50% improvement in ppPASI score, at 16 weeks Secondary Endpoints: • Proportion of participants who achieve at least 50% improvement in the palmoplantar pustular psoriasis area and severity index (ppPASI-50) at 24 weeks.

  • - Frequency of participants with adverse events.
  • - Change from baseline in the Dermatology Quality of Life Index.
  • - Change from baseline in ppPASI.
  • - Percentage of patients who achieved a static Physician's Global Assessment score of 0/1.
  • - Change from baseline in the EQ-5D VAS score.
  • - Change from baseline in itch VAS.
  • - Change from baseline in pain VAS Inclusion Criteria: • Adults aged 18 years of age and older.
  • - Dermatologist confirmed diagnosis of PPP for at least 6 months.
  • - Moderate-severe PPP, defined as a ppPASI > 12.
  • - Inadequate response to topical therapy and a candidate for systemic or phototherapy.
  • - Willing to discontinue current topical and/or systemic PPP treatments, except for OTC emollients Exclusion Criteria: • Participants with other immune-mediated conditions requiring concurrent systemic immunosuppressant treatments.
  • - Current/recent administration of PPP-specific medications including: - Rituximab within 6 months of the baseline visit.
  • - Biologics within 12 weeks of baseline visit.
  • - Systemic steroids, oral immunosuppressants (azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, tacrolimus), oral retinoids (acitretin, isotretinoin), apremilast, or dapsone within 4 weeks of baseline visit.
  • - Phototherapy within 4 weeks of baseline visit.
  • - Prescription topical medications (including calcineurin inhibitors, crisaborole, retinoids, steroids, tar, vitamin D analogs) within 2 weeks of baseline visit.
  • - History of active infection and/or febrile illness within 7 days; or infection requiring antibiotic treatment within 30 days; or serious infection requiring hospitalization and/or IV antibiotics within 90 days.
  • - Evidence of other infection including: - Active or untreated latent tuberculosis, defined as radiographic or laboratory evidence of active TB or positive quantiferon or PPD, unless the subject has completed the recommended treatment.
  • - Human immunodeficiency virus infection (positive HIV antibody) - Active hepatitis B.
  • - Active hepatitis C.
  • - Evidence of clinically significant laboratory abnormality including: - Absolute WBC count < 3000/mm3.
  • - Platelet count < 100,000/mm3.
  • - Hemoglobin < 9.0 g/dl.
  • - ALT or AST > 3 times the upper limit of normal.
  • - History of cancer within the past 5 years, excluding treated non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) - Other uncontrolled chronic medical condition that may interfere with a patient's ability to participate in the clinical trial.
  • - Major surgery within 4 weeks of baseline visit.
  • - Receipt of live vaccine within 8 weeks of baseline visit.
  • - Pregnant or breastfeeding individuals.
  • - Inability to comply with any of the study procedures.
  • - Individuals who are incarcerated or compulsory detained Sample Size: A modified Simon's two-stage design will be used to maximize the safety and efficiency of this clinical trial in an orphan disease.
In the first stage, 8 patients will be accrued. If 2 or fewer patients achieve a ppPASI-50 in these 8 patients, the study will be stopped. Otherwise, 10 additional patients will be accrued for a total of 18. Analysis Plan: Descriptive statistics will be used to characterize the study population, including demographics, disease characteristics and previous treatments. For the primary outcome, the percentage of participants who achieve a ppPASI-50 response, or at least 50% improvement in ppPASI score, at 16 weeks, the response rate with a 95% CI will be calculated. For all secondary endpoints, summary and descriptive statistics will be used as appropriate , including number of observations, calculation of mean/median, standard deviation range and 95% confidence intervals.

Arms & Interventions

Arms

Experimental: Subjects with Palmoplantar pustulosis

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

Interventions

Drug: - Deucravacitinib

See arm/group description

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Liset Chacin, BS

lchacin@bwh.harvard.edu

617-264-5926

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Maryte Papadopoulos

maryte@pennmedicine.upenn.edu

215-662-2408

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