Clinical trial NCT01096862: A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: ASP015K
Psoriasis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score
timeFrame: 6 weeks
measure: Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)
timeFrame: 6 weeks
measure: Change from baseline to end of treatment in percent body surface area (BSA)
timeFrame: 6 weeks
measure: Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center
state: Alabama
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Miami
country: United States
facility: FXM Research, Corp.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Louisville
country: United States
facility: Derm Research, PLLC
state: Kentucky
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology
state: Tennessee
city: College Station
country: United States
facility: J & S Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Madison
country: United States
facility: Madison Skin & Research, Inc
state: Wisconsin
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Papp K, Pariser D, Catlin M, Wierz G, Ball G, Akinlade B, Zeiher B, Krueger JG. A phase 2a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate-to-severe psoriasis. Br J Dermatol. 2015 Sep;173(3):767-76. doi: 10.1111/bjd.13745. Epub 2015 Jun 19.