A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan

Study Identifier
M16-119
CT.gov Identifier
NCT03311464
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dermatology - Other
    • Study Drug
  • adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant must be able and willing to provide written informed consent. If the participant is \< 20 years old, a parent or legal guardian must be willing to give written informed consent * Participants must have a diagnosis of ulcerative (classic) PG made by the Investigator * Participants must have demonstrated an inadequate response to conventional PG therapy or in the opinion of the Investigator they are not a suitable candidate for conventional PG treatment.
    Exclusion Criteria:
    * Participants with pustular, bullous/atypical, or vegetative variants of PG * Participants with clinical evidence of ulceration that is non-PG related, vasculitis, thrombosisprone conditions, or monoclonal gammopathy * Participants with a histopathological finding that is consistent with a diagnosis other than PG * Participants receiving a therapeutic dose of prednisolone * Participants with prior exposure to adalimumab or previous participation in an adalimumab clinical study.

    Protocol Summary

    This study is designed to investigate the efficacy, safety and pharmacokinetics of adalimumab in subjects in Japan with active ulcer(s) due to Pyoderma Gangrenosum (PG).

    Study Locations

    Location
    Status
    Location
    Nagoya City University Hospital /ID# 164510
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Not applicable
    Location
    Juntendo University Urayasu Hospital /ID# 164422
    Urayasu Shi, Chiba, Japan, 279-0021
    Status
    Not applicable
    Location
    Fukuoka University Hospital /ID# 164416
    Fukuoka, Fukuoka, Japan, 814-0180
    Status
    Not applicable
    Location
    Fukushima Medical University Hospital /ID# 164358
    Fukushima, Fukushima, Japan, 960-1295
    Status
    Not applicable
    Location
    Gunma University Hospital /ID# 164464
    Maebashi, Gunma, Japan, 371-8511
    Status
    Not applicable
    Location
    Asahikawa Medical University Hospital /ID# 164589
    Asahikawa-shi, Hokkaido, Japan, 078-8510
    Status
    Not applicable
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