A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis
- Registration Number
- NCT01096862
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo Group 2 peficitinib low dose Group 1 peficitinib lowest dose Group 3 peficitinib high dose Group 5 peficitinib medium dose Group 4 peficitinib highest dose
- Primary Outcome Measures
Name Time Method Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) 6 weeks Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score 6 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (11)
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Derm Research, PLLC
🇺🇸Louisville, Kentucky, United States
Palmetto Clinical Trial Services
🇺🇸Greenville, South Carolina, United States
Virginia Clinical Research
🇺🇸Norfolk, Virginia, United States
J & S Studies
🇺🇸College Station, Texas, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Rivergate Dermatology
🇺🇸Goodlettsville, Tennessee, United States
Total Skin & Beauty Dermatology Center
🇺🇸Birmingham, Alabama, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
FXM Research, Corp.
🇺🇸Miami, Florida, United States
Madison Skin & Research, Inc
🇺🇸Madison, Wisconsin, United States