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

Astellas Pharma Inc124 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

124

Conditions

Psoriasis

Interventions

peficitinibDRUG

oral

PlaceboDRUG

oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, United States

Therapeutics Clinical Research

San Diego, California, United States

FXM Research, Corp.

Miami, Florida, United States

Outcomes

Primary Outcomes

Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score

Time frame: 6 weeks

Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)

Time frame: 6 weeks

Secondary Outcomes

Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)

Time frame: 6 weeks

Change from baseline to end of treatment in percent body surface area (BSA)

Time frame: 6 weeks

Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear

Time frame: 6 weeks

Data from ClinicalTrials.gov

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