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Astellas Study ID
7163-CL-0107

A Multiple Dose Escalation Study of ASKP1240 in Subjects with Moderate to Severe Plaque Psoriasis

Astellas Study ID
NCT01585233
Clinicaltrials.gov ID
NCT01585233
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

The purpose of this study is to explore the safety and tolerability of multiple doses of ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects with moderate to severe psoriasis.

Additional Study Details

Phase
Phase 2
Product
  • ASKP1240
  • Placebo
    • Type
    Interventional
    Masking
    Double (Participant, Investigator)
    Enrollment number
    60
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Download Document(s)
    Plain Language Summary
    Available Language(s): English
    Download Document(s)

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    Would you like more information about clinical trial sites that are recruiting participants for A Multiple Dose Escalation Study of ASKP1240 in Subjects with Moderate to Severe Plaque Psoriasis? Contact us by filling out your information to the right and we’ll respond to you.

    • A caregiver
    • A healthcare provider
    • A parent
    • A patient
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

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      Contact Us
      Completed
      Specialist Connect
      Brisbane, Queensland, Australia, 4102
      Contact Us
      Completed
      CMAX
      Adelaide, Victoria, Australia, 5000
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      Completed
      Epworth Hospital
      Richmond, Victoria, Australia, 3121
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      Completed
      Linear Research
      Nedlands, WESTERN AUSTRALIA, Australia, 6009
      Contact Us
      Withdrawn
      Winnipeg Clinic
      Winnipeg, Manitoba, Canada, R3C 0N2
      Contact Us
      Completed
      Durondel C.P. Inc, The Dermatology Clinic
      Moncton, New Brunswick, Canada, E1C 8X3
      Contact Us
      Completed
      New Lab Clinical Research
      St. John's, Newfoundland, Canada, A1C 2H5
      Contact Us
      Completed
      Ultranova Skincare
      Barrie, Ontario, Canada, L4M 6L2
      Contact Us
      Completed
      K. Papp Clinical Research
      Waterloo, Ontario, Canada, N2J 1C4
      Contact Us
      Completed
      Innovaderm Research, Inc.
      Montreal, Quebec, Canada, H2K 4L5
      Contact Us
      Completed
      Auckland Clinical Studies
      Auckland, New Zealand, 1010
      Contact Us
      Completed
      Christchurch Clincial Studies Trust, Ltd.
      Christchurch, New Zealand, 8011
      Contact Us
      Completed
      P3 Research, Tauranga
      Tauranga, New Zealand, 3110
      Contact Us
      Completed
      P3 Research, Wellington
      Wellington, New Zealand, 6021
      Contact Us
      Trial info
      Follow Trial
      Age
      18 - 75 Years
      Diamond icon
      Condition
    • Psoriasis
      • Gender icon
      Sex
      Female & Male
      Calendar icon
      Trial Dates
      Apr 2012 - Jun 2014
      Additional Study Details
      Inclusion Criteria

        Inclusion Criteria:

      • Subject has a clinical diagnosis of moderate to severe plaque psoriasis for 6 months or longer with at least 5% or greater Body Surface Area (BSA) affected with plaque psoriasis
      • Subject must be a candidate for phototherapy and/or systemic therapy
      • Subject must agree to avoid prolonged exposure to the sun and avoid the use of tanning booths or other ultraviolet light sources during the study
      • Female subject must be either:
        • post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
        • premenarchal prior to Screening, or
        • documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening), or
      • if of childbearing potential, must have a negative serum pregnancy test at Screening and if sexually active must be using highly effective contraception. All sexually active subjects will be required to use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days [or 5 five half lives of the study drug whichever is longer] after final study drug administration.
      • Female subject must not be lactating and must not be breastfeeding at Screening or during the study period and for 28 days [or 5 five half lives of the study drug whichever is longer] after final study drug administration.
      • Female subject must not donate ova starting at Screening and throughout the study period and for 28 days [or 5 five half lives of the study drug whichever is longer] after final study drug administration.
      • Male subject and their female spouse/partners who are sexually active must be using highly effective contraception1 consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 28 days [or 5 five half lives of the study drug whichever is longer] after final study drug administration.
      • Male subject must not donate sperm starting at Screening and throughout the study period and for at least 28 days [or 5 five half lives of the study drug whichever is longer] after final study drug administration.
      • Highly effective contraception is defined as:
        • Established use of oral, injected or implanted hormonal methods of contraception.
        • Placement of an intrauterine device (IUD) or intrauterine system (IUS)
        • Barrier methods of contraception: Condom alone or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
      • Subject must be willing and able to comply with the study requirements, including prohibited concomitant medication restrictions.
      • Waivers to the inclusion criteria will NOT be allowed.

        • Exclusion Criteria:

      • Subject has non-plaque psoriasis (such as guttate, erythrodermic or pustular psoriasis)
      • Subject has received treatment with systemic, non-biologic psoriasis therapy or other systemic immunosuppressant including investigational use of an approved agent within the last 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
      • Subject has ever been treated with efalizumab (Raptiva®)
      • Subject has a total B lymphocyte count by flow cytometric determination that is less than the lower limit of normal
      • Subject has a hemoglobin, that are below the lower limit
      • Subject has a total white count, total lymphocyte count, total neutrophil count or total platelet that are below the lower limit
      • Subject has any of the following lab values:
        • ALT ≥ 1.5 x upper limit of normal
        • AST ≥ 1.5 x upper limit of normal
        • Total bilirubin ≥ 1.5 x upper limit of normal
      • Subject has previously received ASKP1240 or has participated in a study involving ASKP1240
      • Subject has > 45 body mass index (BMI)
      • Subject with a positive Tubercle Bacillus (TB) test who has not previously received adequate antimicrobial therapy for TB or is currently on, or is planned to start TB antimicrobial therapy
      • Subject has abnormal chest x-ray indicative of acute or chronic lung disease
      • Subject has uncontrolled intercurrent illness, including, but not limited to ongoing or active infection, any clinically significant cardiac disease seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements
      • Subject has a history of any malignancy regardless of the location and the time of diagnosis in the last 5 years (including in-situ carcinoma of the cervix, but excluding successfully treated non-metastatic basal cell and squamous cell carcinoma)
      • Subject has received live or live attenuated virus vaccinations within the last 30 days prior to first dose of study drug
      • Subject has received treatment with another investigational drug within 30 days or 5 half-lives; whichever is longer, prior to the initiation of Screening
      • Subject has a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody
      • Subject has a history of a positive test for human immunodeficiency virus (HIV) infection
      • Subject has received treatment with systemic, biologic psoriasis therapy or other systemic immunosuppressant including investigational use of an approved agent within the last 56 days or 5 half-lives whichever is longer, prior to the first dose of study drug
      • Waivers to the exclusion criteria will NOT be allowed.

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