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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01096862
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: peficitinib Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2010
Actual Primary Completion Date : July 27, 2011
Actual Study Completion Date : July 27, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
lowest dose
 Drug: peficitinib
oral
Other Name: ASP015K
Experimental: Group 2
low dose
 Drug: peficitinib
oral
Other Name: ASP015K
Experimental: Group 3
high dose
 Drug: peficitinib
oral
Other Name: ASP015K
Experimental: Group 4
highest dose
 Drug: peficitinib
oral
Other Name: ASP015K
Experimental: Group 5
medium dose
 Drug: peficitinib
oral
Other Name: ASP015K
Placebo Comparator: Placebo
Matching placebo
 Drug: Placebo
oral


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score [ Time Frame: 6 weeks ]
  2. Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA) [ Time Frame: 6 weeks ]
  2. Change from baseline to end of treatment in percent body surface area (BSA) [ Time Frame: 6 weeks ]
  3. Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096862


Locations
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United States, Alabama
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Florida
FXM Research, Corp.
Miami, Florida, United States, 33175
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Kentucky
Derm Research, PLLC
Louisville, Kentucky, United States, 40217
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, South Carolina
Palmetto Clinical Trial Services
Greenville, South Carolina, United States, 29607
United States, Tennessee
Rivergate Dermatology
Goodlettsville, Tennessee, United States, 37072
United States, Texas
J & S Studies
College Station, Texas, United States, 77845
United States, Virginia
Virginia Clinical Research
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Madison Skin & Research, Inc
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Global Development
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01096862    
Other Study ID Numbers: 015K-CL-PS01
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/
Keywords provided by Astellas Pharma Inc:
ASP015K
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Peficitinib
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs