Deucravacitinib for the Treatment of Palmoplantar Pustulosis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subjects with Palmoplantar pustulosis All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. |
Drug: Deucravacitinib
See arm/group description
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants who achieve a ppPASI-50 response, or at least 50% improvement in ppPASI score [16 weeks]
The ppPASI is the most commonly used disease severity measure use in palmoplantar pustulosis clinic trials. The ppPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity
Secondary Outcome Measures
- Proportion of participants who achieve a ppPASI-50 response, or at least 50% improvement in ppPASI score [Week 24]
The ppPASI is the most commonly used disease severity measure use in palmoplantar pustulosis clinic trials. The ppPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity
- Change from baseline in the Dermatology Quality Life Index (DLQI) [Week 16, Week 24]
The DLQI is a dermatology-specific quality of life instrument to measure the impact of skin disease on different aspects of health-related quality of life. The questionnaire contains 10 questions, each scored on a 4-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
- Change from baseline in ppPASI [Week 16, Week 24]
The ppPASI is the most commonly used disease severity measure use in palmoplantar pustulosis clinic trials. The ppPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity
- Percentage of patient who achieve a Physicians Global Assessment Score of 0 or 1 [Week 16, Week 24]
The physician's global assessment is a widely used outcome measure that relies on physician visual assessment of disease severity. The static PGA determines psoriasis severity at a single point in time, without taking the baseline disease condition into clear (0), almost clear (1), mild (2), moderate (3), severe (4).
- Change from baseline in EQ-5D VAS [Week 16, Week 24]
The EQ-5D is a validated, reliable, and responsive instrument widely used in clinical trials where respondents rate their health in each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety depression. EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
- Change from baseline in the itch visual analogue scale (itch-VAS) [Week 16, Week 24]
The VAS-itch is a 10 cm line on which patients mark their pruritus intensity on a scale from "no itch" (0 points) to "worst imaginable itch" (10 points). The VAS-itch can be interpreted as 0 - < 3 points represents mild pruritus, ≥ 3 - 7 points moderate pruritus, ≥ 7 - 9 points severe pruritus, and ≥ 9 points severe pruritus
- Change from baseline in the pain visual analogue scale (pain-VAS) [Week 16, 24]
The VAS-pain is a 10 cm line on which patients mark their pain on a scale from "no no" (0 points) to "worst imaginable pain" (100 points). The following cut points on the pain VAS have been recommended pain: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75 - 100 mm)
Eligibility Criteria
Criteria
Inclusion Criteria:
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• Adults aged 18 years of age and older
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Dermatologist confirmed diagnosis of PPP for at least 6 months
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Moderate-severe PPP, defined as a ppPASI > 12
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Inadequate response to topical therapy and a candidate for systemic or phototherapy
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Willing to discontinue current topical and/or systemic PPP treatments, except for OTC emollients
Exclusion Criteria:
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• Participants with other immune-mediated conditions requiring concurrent systemic immunosuppressant treatments
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Current/recent administration of PPP-specific medications including:
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Rituximab within 6 months of the baseline visit
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Biologics within 12 weeks of baseline visit
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Systemic steroids, oral immunosuppressants (azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, tacrolimus), oral retinoids (acitretin, isotretinoin), apremilast, or dapsone within 4 weeks of baseline visit
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Phototherapy within 4 weeks of baseline visit
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Prescription topical medications (including calcineurin inhibitors, crisaborole, retinoids, steroids, tar, vitamin D analogs) within 2 weeks of baseline visit
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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
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Evidence of other infection including:
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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
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Human immunodeficiency virus infection (positive HIV antibody)
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Active hepatitis B
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Active hepatitis C
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Evidence of clinically significant laboratory abnormality including:
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Absolute WBC count < 3000/mm3
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Platelet count < 100,000/mm3
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Hemoglobin < 9.0 g/dl
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ALT or AST > 3 times the upper limit of normal
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History of cancer within the past 5 years, excluding treated non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma)
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Other uncontrolled chronic medical condition that may interfere with a patient's ability to participate in the clinical trial
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Major surgery within 4 weeks of baseline visit
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Receipt of live vaccine within 8 weeks of baseline visit
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Pregnant or breastfeeding individuals
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Inability to comply with any of the study procedures
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Individuals who are incarcerated or compulsory detained
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Brigham and Women's Hospital
- University of Pennsylvania
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022P0000000