Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis

Study Overview
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Brief Summary
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A phase 4 multicenter, randomized, placebo-controlled Study evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients with moderate-to-severe Scalp Psoriasis

Detailed Description
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The scalp is the most frequently affected body region in psoriasis. Scalp Psoriasis can impair the quality of life greatly due to pruritus. This is however not usually investigated as a primary outcome of treatments. This study will investigate the effects of apremilast on the pruritus and quality of life and other patient reported outcomes in patients with scalp psoriasis.

Official Title
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A Phase 4 Multicenter, Randomized, Placebo-controlled Study Evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients With Moderate-to-severe Scalp Psoriasis

Conditions
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Psoriasis of Scalp, Psoriasis Vulgaris

Intervention / Treatment
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* Drug: Apremilast 30mg
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult (>18yrs); Signed informed consent Clinical diagnosis of chronic plaque psoriasis for at least 3 months as determined by the subject's medical history and confirmation of diagnosis through physical examination by the Investigator; Psoriatic lesions with DLQI >10 and involvement of >20% of the scalp and pruritus with a VAS score of > 50 (0-100); Candidate for systemic therapy; Females who are of child-bearing potential should be practicing birth control throughout the study and for 70 days after the last dose of study drug; Subject is judged to be in good health as determined by the Investigator based upon the results of medical history, laboratory profile and physical examination. Creatinine < 80 umol/l at Inclusion Exclusion criteria: Erythrodermic Ps, medication-induced or medication-exacerbated Ps or new onset guttate Ps or other skin conditions at the time of the screening visit (e.g. eczema) that would interfere with evaluations of the effect of the investigational product on Ps; Use of any anti-psoriatic therapy last administered less than 4 weeks of start of study drug such as Three months or 5 PK half-lives, whichever is longer, for biologics tumor necrosis factor (TNF) antagonists, interleukin (IL) 12/23/17 inhibitors or other biologic drugs 4 weeks for immunosuppressive / -modulating drugs including cyclosporine A, methotrexate, azathioprine, mycophenolate mofetil, fumaric acid esters, retinoids, JAK inhibitors, corticosteroids, any other experimental drug, etc. Topical medications (eg. Corticosteroids) except coal tar shampoo, and/or salicylic acid scalp preparations on scalp lesions. 4 weeks for phototherapy (ie, UVB, PUVA). Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit; Positive serology for hepatitis B, hepatitis C, HIV indicating acute or chronic infection; Chronic recurring bacterial infections or active TB; Positive pregnancy test at Screening or at the Baseline visit; Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study; History of clinically significant alcohol or drug abuse in the last 12 months; Known hypersensitivity to the excipients of Otezla® as stated in the label; Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>Apremilast 30mg bd | Drug: Apremilast 30mg<br>* Anti-psoriatic drug<br>* Other names: Otezla;|
| Placebo Comparator: Placebo Oral Tablet<br>Excipiens | Drug: Placebo Oral Tablet<br>* Indistinguishable tablets not containing apremilast, Placebo Oral Tablet<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scalp VAS Pruritus assessment | Pruritus VAS Scale (0 - 100) | Weeks 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scalp VAS Pruritus assessment | Pruritus VAS Scale (0 - 100) | Weeks 0, 4, 32, 52 | 
| % BSA | Body surface area | Weeks 0, 4, 16, 32, 52 | 
| % BSA of scalp | Body surface area of scalp | Weeks 0, 4, 16, 32, 52 | 
| PrecisePASI | Psoriasis Area and Severity Index, modified to measure in percentages | Weeks 0, 4, 16, 32, 52 | 
| PGA | Physicians Global Assessment (0 - 5) | Weeks 0, 4, 16, 32, 52 | 
| Scalp-PGA | Physicians Global Assessment of the Scalp (0 - 5) | Weeks 0, 4, 16, 32, 52 | 
| DLQI | Skin related Quality of life (0 to 30) | Weeks 0, 4, 16, 32, 52 | 
| Scalpdex | 23 items related to scalp symptoms | Weeks 0, 4, 16, 32, 52 | 
| PSSI | Psoriasis score measuring intensity on the scalp | Weeks 0, 4, 16, 32, 52 | 
| VAS pruritus assessment | Pruritus VAS Scale (0 - 100) | Weeks 0, 4, 16, 32, 52 | 
| EQ-5D | Health-related Quality of Life Instrument | Weeks 0, 4, 16, 32, 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pruritus, apremilast, quality of life, oral drug, placebo