A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)

Study Identifier
P20-442
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
  • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    12 - 17 Years

    Protocol Summary

    Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to \<18 years old in Japan in the real-world setting.

    Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to \<18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan.

    Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

    There will be no additional 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 and will be asked to provide additional information by questionnaire at each visit.

    Study Locations

    Location
    Status
    Location
    Takeo Skin Clinic /ID# 248095
    Asahi Owari, Aichi-ken, Japan, 488-0032
    Status
    Not applicable
    Location
    Ichinomiya Municipal Hospital /ID# 245070
    Ichinomiya-shi, Aichi-ken, Japan, 491-8558
    Status
    Not applicable
    Location
    NHO Nagoya Medical Center /ID# 245069
    Nagoya, Aichi-ken, Japan, 460-0001
    Status
    Not applicable
    Location
    Nagoya City University Hospital /ID# 250809
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Not applicable
    Location
    Aichi Children's Health and Medical Center /ID# 245357
    Obu-shi, Aichi-ken, Japan, 474-8710
    Status
    Not applicable
    Location
    Noriko Dermatology Clinic /ID# 246626
    Akita, Akita, Japan, 010-0062
    Status
    Not applicable
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