A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to explore the efficacy and safety of multiple, escalating doses of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.

Detailed Description
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Following completion of at least 1 week of study drug for all subjects in group 1, the Sponsor will review the safety information of these subjects prior to enrolling off-treatment subjects into the next dose group. Dose escalation will continue in this manner (unless stopping criteria are met) until all groups have completed the study.

Official Title
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A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Sequential Group, Multiple-Dose Escalation Study to Evaluate the Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: peficitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has moderate to severe plaque psoriasis for 6 months or longer with at least 10% Body Surface Area (BSA) affected Subject must be a candidate for phototherapy and/or systemic therapy Exclusion Criteria: Subject has non-plaque psoriasis or drug-induced psoriasis Subject is on systemic psoriasis therapy within 56 days or 5 half-lives, whichever is longer, prior to first dose of study drug Subject has a positive TB skin test within 3 months of screening or at screening Subject has an abnormal chest x-ray

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: Group 1<br>lowest dose | Drug: peficitinib<br>* oral<br>* Other names: ASP015K;|
| Experimental: Group 2<br>low dose | Drug: peficitinib<br>* oral<br>* Other names: ASP015K;|
| Experimental: Group 3<br>high dose | Drug: peficitinib<br>* oral<br>* Other names: ASP015K;|
| Experimental: Group 4<br>highest dose | Drug: peficitinib<br>* oral<br>* Other names: ASP015K;|
| Experimental: Group 5<br>medium dose | Drug: peficitinib<br>* oral<br>* Other names: ASP015K;|
| Placebo Comparator: Placebo<br>Matching placebo | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score |  | 6 weeks | 
| Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA) |  | 6 weeks | 
| Change from baseline to end of treatment in percent body surface area (BSA) |  | 6 weeks | 
| Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP015K, Psoriasis