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. Identifier: NCT01096862
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : July 25, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: ASP015K 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Single Group 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
Study Start Date : March 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1
lowest dose
Drug: ASP015K
Experimental: Group 2
low dose
Drug: ASP015K
Experimental: Group 3
high dose
Drug: ASP015K
Experimental: Group 4
highest dose
Drug: ASP015K
Experimental: Group 5
medium dose
Drug: ASP015K
Placebo Comparator: Placebo Drug: Placebo

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01096862

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
Study Director: Medical Director Astellas Pharma Global Development

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT01096862     History of Changes
Other Study ID Numbers: 015K-CL-PS01
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases