An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China

Study Identifier
P24-965
CT.gov Identifier
NCT06421740
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    12+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Adolescents (body weight \>= 40 kg at the Baseline Visit for patients between \>= 12 and \< 18 years of age) and adults at the time of enrollment. * Clinical diagnosis of moderate to severe atopic dermatitis at the time of enrollment. * UPA treatment is indicated for AD and prescribed as per Chinese label / SmPC. * The decision to prescribe UPA is made prior to and independent of study participation. * The participant should not be treated with UPA prior to this study. * Participants who are willing and able to participate in the collection of patient-reported data, including ePROs and eDiary via apps. * The participant (legal representative for adolescents) voluntarily signed an informed consent before any study-related activities are conducted.
    Exclusion Criteria:
    * The participant is currently participating in interventional research (not including noninterventional study, observational study, or registry participation). * Any circumstances that the investigator believes may limit the patient's participation and compliance with study procedures.

    Protocol Summary

    Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin.

    Upadacitinib is an approved drug for treating AD. Approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in China.

    Participants will receive oral upadacitinib tablets as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 12 months.

    There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

    Study Locations

    Location
    Status
    Location
    Beijing Anzhen Hospital /ID# 273443
    Beijing, Beijing Municipality, China, 100029
    Status
    Active, Not Recruiting
    Location
    China-Japan Friendship Hospital /ID# 274778
    Beijing, Beijing Municipality, China, 100029
    Status
    Active, Not Recruiting
    Location
    Peking University First Hospital /ID# 274865
    Beijing, Beijing Municipality, China, 100034
    Status
    Active, Not Recruiting
    Location
    Peking Unversity Third hospital /ID# 274864
    Beijing, Beijing Municipality, China, 100191
    Status
    Active, Not Recruiting
    Location
    Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 264193
    Beijing, Beijing Municipality, China, 100730
    Status
    Active, Not Recruiting
    Location
    The First Affiliated Hospital Of Fujian Medical University /ID# 268210
    Fuzhou, Fujian, China, 350005
    Status
    Active, Not Recruiting
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