Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

Study Identifier
M14-193
CT.gov Identifier
NCT02533375
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
  • Heart, Blood & Circulatory - Other
  • Other
    • Study Drug
  • Adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    15 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of generalized pustular psoriasis * Total skin score of at least 3 and erythema with pustules (skin score of at least 1) at baseline in the Japan Dermatology Association (JDA) severity index of Generalized Pustular Psoriasis (GPP) in GPP Medical Care Guideline 2014 in Japan * Inadequate response to, or intolerance to, or contraindication to the currently approved GPP treatment (excluding infliximab) * Infliximab secondary failure, or intolerant to infliximab
    Exclusion Criteria:
    * Erythrodermic psoriasis, guttate psoriasis or sub-corneal pustular dermatosis at Screening * Drug-induced GPP * Cannot stop ongoing use of prohibited GPP treatments * Total JDA severity index of GPP of 14 or more in GPP Medical Care Guideline 2014 in Japan

    Protocol Summary

    The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not have an adequate response to their currently approved treatment.

    Study Locations

    No locations found.