A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis
NCT ID: NCT01096862
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2010-03-23
2011-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
lowest dose
peficitinib
oral
Group 2
low dose
peficitinib
oral
Group 3
high dose
peficitinib
oral
Group 4
highest dose
peficitinib
oral
Group 5
medium dose
peficitinib
oral
Placebo
Matching placebo
Placebo
oral
Interventions
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peficitinib
oral
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must be a candidate for phototherapy and/or systemic therapy
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States
Therapeutics Clinical Research
San Diego, California, United States
FXM Research, Corp.
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Derm Research, PLLC
Louisville, Kentucky, United States
Oregon Medical Research Center
Portland, Oregon, United States
Palmetto Clinical Trial Services
Greenville, South Carolina, United States
Rivergate Dermatology
Goodlettsville, Tennessee, United States
J & S Studies
College Station, Texas, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Madison Skin & Research, Inc
Madison, Wisconsin, United States
Countries
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References
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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.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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015K-CL-PS01
Identifier Type: -
Identifier Source: org_study_id
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