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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01096862

Enrollment

124

Registered

2010-03-31

Start date

2010-03-23

Completion date

2011-07-27

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

ASP015K, Psoriasis

Brief summary

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

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.

Interventions

DRUGpeficitinib

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Change from baseline to end of treatment in percent body surface area (BSA)	6 weeks
Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026