Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis

Study Identifier
M19-135
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Immune & Inflammatory - Other
  • Study Drug
  • Risankizumab
  • Placebo
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Palmoplantar pustulosis is a chronic inflammatory skin disease that causes repeated on and off symptoms like erythema (reddening, irritation), vesicle (swelling, cyst), pustules, scale, and crusts in palms and soles. This study evaluates how well risankizumab works compared to placebo (no medicine) to treat palmoplantar pustulosis. Study will assess change in Palmoplantar Pustulosis Area and Severity Index \[PPPASI\].

    Risankizumab is an investigational drug being developed for the treatment of palmoplantar pustulosis. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given study drug and who will receive placebo (no medicine). Participants are randomly put into 1 of 2 groups, called treatment arms to receive risankizumab or placebo in period A. In period B, each group receives both risankizumab and placebo at different time intervals. Around 116 adult participants with palmoplantar pustulosis will be enrolled in approximately 39 sites across Japan.

    Participants will receive subcutaneous (SC) injections of risankizumab or placebo at Week 0 and Week 4 (Period A). Beginning Week 16 (Period B), both the groups will receive risankizumab and placebo at different intervals. Total treatment duration is 56 weeks.

    There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Ichinomiya Municipal Hospital /ID# 222581
    Ichinomiya-shi, Aichi-ken, Japan, 491-8558
    Status
    Not applicable
    Location
    Chukyo Hospital /ID# 218894
    Nagoya, Aichi-ken, Japan, 457-8510
    Status
    Not applicable
    Location
    Nagoya City University Hospital /ID# 221258
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Not applicable
    Location
    Fujita Health University Hospital /ID# 221285
    Toyoake-shi, Aichi-ken, Japan, 470-1192
    Status
    Not applicable
    Location
    Toho University Sakura Medical Center /ID# 220858
    Sakura-shi, Chiba, Japan, 285-8741
    Status
    Not applicable
    Location
    Ehime University Hospital /ID# 221260
    Toon-shi, Ehime, Japan, 791-0295
    Status
    Not applicable
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