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

Astellas

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: peficitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096862

015K-CL-PS01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

124 participants in 6 patient groups, including a placebo group

Group 1

Experimental group

Description:

lowest dose

Treatment:

Drug: peficitinib

Group 2

Experimental group

Description:

low dose

Treatment:

Drug: peficitinib

Group 3

Experimental group

Description:

high dose

Treatment:

Drug: peficitinib

Group 4

Experimental group

Description:

highest dose

Treatment:

Drug: peficitinib

Group 5

Experimental group

Description:

medium dose

Treatment:

Drug: peficitinib

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo