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Sponsor terminated funding
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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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.
Objectives:
Evaluate the efficacy of deucravacitinib in adults with PPP
Evaluate the impact of deucravacitinib on quality of life in adults with PPP
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:
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:
Evidence of clinically significant laboratory abnormality including:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Palmoplantar pustulosis | Experimental | All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | See arm/group description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score | 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 | 16 weeks |
| Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score | 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. This second Primary Outcome was added by administrative error since the study only has one Primary Outcome Measure. Hence, the outcome and results are a duplication of the outcome measure reported, and this one was left incomplete in the previous results reporting submission. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Dermatology Quality Life Index (DLQI) | 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. |
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Inclusion Criteria:
• Adults aged 18 years of age and older
Exclusion Criteria:
• Participants with other immune-mediated conditions requiring concurrent systemic immunosuppressant treatments
Current/recent administration of PPP-specific medications including:
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:
Evidence of clinically significant laboratory abnormality including:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| University of Pennsylvania |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Palmoplantar Pustulosis | All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Deucravacitinib: See arm/group description |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Palmoplantar Pustulosis | All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Deucravacitinib: See arm/group description |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score | 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 | Posted | Count of Participants | Participants | 16 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Palmoplantar Pustulosis | All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Deucravacitinib: See arm/group description |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment | Ear infection requiring antibiotic treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials, Brigham and Women's Hospital Department of Dermatology | Brigham and Women's Hospital | 617-732-5500 | amostaghimi@mgb.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2024 | Oct 10, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| Week 16, Week 24 |
| Change From Baseline in ppPASI | 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 | Week 16, Week 24 |
| Number of Patients Who Achieve a Physicians Global Assessment Score of 0 or 1 | 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). | Week 16, Week 24 |
| Change From Baseline in EQ-5D VAS | 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). | Week 16, Week 24 |
| Change From Baseline in the Itch Visual Analogue Scale (Itch-VAS) | 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" (100 points). The VAS-itch can be interpreted as 0 - < 30 points represents mild pruritus, ≥ 30 - 70 points moderate pruritus, ≥ 70 - 90 points severe pruritus, and ≥ 90 points severe pruritus | Week 16, Week 24 |
| Change From Baseline in the Pain Visual Analogue Scale (Pain-VAS) | 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) | Week 16, 24 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| Primary | Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score | 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. This second Primary Outcome was added by administrative error since the study only has one Primary Outcome Measure. Hence, the outcome and results are a duplication of the outcome measure reported, and this one was left incomplete in the previous results reporting submission. | Posted | Count of Participants | Participants | 16 weeks |
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| Secondary | Change From Baseline in the Dermatology Quality Life Index (DLQI) | 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. | The trial was terminated early due to the decision of the financial sponsor. A total of three participants were enrolled at Penn Medicine. In a complete case analysis of participants with data available at both baseline and Week 16 (n=2). Only one patient completed study at Week 24 | Posted | Mean | Standard Deviation | units on a scale | Week 16, Week 24 |
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| Secondary | Change From Baseline in ppPASI | 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 | The trial was terminated early due to the decision of the financial sponsor. A total of three participants were enrolled at Penn Medicine. In a complete case analysis of participants with data available at both baseline and Week 16 (n=2). Only one patient completed the study at Week 24 | Posted | Mean | Standard Deviation | units on a scale | Week 16, Week 24 |
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| Secondary | Number of Patients Who Achieve a Physicians Global Assessment Score of 0 or 1 | 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). | The trial was terminated early due to the decision of the financial sponsor. A total of three participants were enrolled at Penn Medicine. In a complete case analysis of participants with data available at both baseline and Week 16 (n=2). Only one patient completed study at Week 24 | Posted | Number | participants | Week 16, Week 24 |
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| Secondary | Change From Baseline in EQ-5D VAS | 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). | The trial was terminated early due to the decision of the financial sponsor. A total of three participants were enrolled at Penn Medicine. In a complete case analysis of participants with data available at both baseline and Week 16 (n=2). Only one patient completed the study at Week 24. | Posted | Mean | Standard Deviation | units on a scale | Week 16, Week 24 |
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| Secondary | Change From Baseline in the Itch Visual Analogue Scale (Itch-VAS) | 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" (100 points). The VAS-itch can be interpreted as 0 - < 30 points represents mild pruritus, ≥ 30 - 70 points moderate pruritus, ≥ 70 - 90 points severe pruritus, and ≥ 90 points severe pruritus | The trial was terminated early due to the decision of the financial sponsor. A total of three participants were enrolled at Penn Medicine. In a complete case analysis of participants with data available at both baseline and Week 16 (n=2). Only one patient completed study at Week 24 | Posted | Mean | Standard Deviation | units on a scale | Week 16, Week 24 |
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| Secondary | Change From Baseline in the Pain Visual Analogue Scale (Pain-VAS) | 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) | The trial was terminated early due to the decision of the financial sponsor. A total of three participants were enrolled at Penn Medicine. In a complete case analysis of participants with data available at both baseline and Week 16 (n=2). Only one patient completed study at Week 24 | Posted | Mean | Standard Deviation | units on a scale | Week 16, 24 |
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