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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01096862
Collaborator
(none)
124
Enrollment
11
Locations
6
Arms
16.1
Actual Duration (Months)
11.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Mar 23, 2010
Actual Primary Completion Date :
Jul 27, 2011
Actual Study Completion Date :
Jul 27, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

lowest dose

Drug: peficitinib
oral
Other Names:
  • ASP015K

    		•
    Experimental: Group 2

    low dose

    Drug: peficitinib
    oral
    Other Names:
  • ASP015K

    		•
    Experimental: Group 3

    high dose

    Drug: peficitinib
    oral
    Other Names:
  • ASP015K

    		•
    Experimental: Group 4

    highest dose

    Drug: peficitinib
    oral
    Other Names:
  • ASP015K

    		•
    Experimental: Group 5

    medium dose

    Drug: peficitinib
    oral
    Other Names:
  • ASP015K

    		•
    Placebo Comparator: Placebo

    Matching placebo

    Drug: Placebo
    oral

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score [6 weeks]

    2. Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) [6 weeks]

    Secondary Outcome Measures

    1. Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA) [6 weeks]

    2. Change from baseline to end of treatment in percent body surface area (BSA) [6 weeks]

    3. Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Total Skin & Beauty Dermatology Center Birmingham Alabama United States 35205
    2 Therapeutics Clinical Research San Diego California United States 92123
    3 FXM Research, Corp. Miami Florida United States 33175
    4 Renstar Medical Research Ocala Florida United States 34471
    5 Derm Research, PLLC Louisville Kentucky United States 40217
    6 Oregon Medical Research Center Portland Oregon United States 97223
    7 Palmetto Clinical Trial Services Greenville South Carolina United States 29607
    8 Rivergate Dermatology Goodlettsville Tennessee United States 37072
    9 J & S Studies College Station Texas United States 77845
    10 Virginia Clinical Research Norfolk Virginia United States 23507
    11 Madison Skin & Research, Inc Madison Wisconsin United States 53719

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Director: Medical Director, Astellas Pharma Global Development

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01096862
    Other Study ID Numbers:
    • 015K-CL-PS01
    First Posted:
    Mar 31, 2010
    Last Update Posted:
    Jun 11, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Astellas Pharma Inc
    ASP015K
    Psoriasis
    Additional relevant MeSH terms:
    Psoriasis
    Peficitinib

    Study Results

    No Results Posted as of Jun 11, 2019