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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01096862
First received: March 18, 2010
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Psoriasis
Drug: ASP015K
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of treatment in percent body surface area (BSA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
lowest dose
Drug: ASP015K
oral
Experimental: Group 2
low dose
Drug: ASP015K
oral
Experimental: Group 3
high dose
Drug: ASP015K
oral
Experimental: Group 4
highest dose
Drug: ASP015K
oral
Experimental: Group 5
medium dose
Drug: ASP015K
oral
Placebo Comparator: Placebo Drug: Placebo
oral

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096862

Locations
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
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01096862     History of Changes
Other Study ID Numbers: 015K-CL-PS01
Study First Received: March 18, 2010
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Psoriasis
ASP015K

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014