Deucravacitinib for the Treatment of Palmoplantar Pustulosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score
研究概览
简要总结
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.
详细描述
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
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Frequency of participants with adverse events
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Change from baseline in the Dermatology Quality of Life Index
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Change from baseline in ppPASI
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Percentage of patients who achieved a static Physician's Global Assessment score of 0/1
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Change from baseline in the EQ-5D VAS score
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Change from baseline in itch VAS
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Change from baseline in pain VAS Inclusion Criteria: • 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: • 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
-
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •• 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
研究组 & 干预措施
Subjects with Palmoplantar pustulosis
All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks.
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score
时间窗: 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. 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.
次要结局
- Change From Baseline in the Dermatology Quality Life Index (DLQI)(Week 16, Week 24)
- Change From Baseline in ppPASI(Week 16, Week 24)
- Percentage of Patient Who Achieve a Physicians Global Assessment Score of 0 or 1(Week 16, Week 24)
- Change From Baseline in the Pain Visual Analogue Scale (Pain-VAS)(Week 16, 24)
- Change From Baseline in EQ-5D VAS(Week 16, Week 24)
- Change From Baseline in the Itch Visual Analogue Scale (Itch-VAS)(Week 16, Week 24)
研究者
Arash Mostaghimi, M.D., M.P.A., M.P.H.
Associate Professor of Dermatology
Brigham and Women's Hospital