Real World Study of Oral Upadacitinib Tablets to Assess Adverse Events and Change in Disease Activity in Adolescent and Adult Chinese Participants With Atopic Dermatitis

Study Identifier
P21-702
CT.gov Identifier
NCT05959083
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

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:
    * Diagnosis of moderate to severe atopic dermatitis (AD) at the time of enrollment. * Chinese adolescents (≥12 to \<18 years of age with body weight of ≥40 kg) or adults (≥18 years of age) at the time of enrollment. * Participants eligible for initiation of Upadacitinib treatment for AD, including any required screening tests indicated per China Label. * The decision to prescribe Upadacitinib is made prior to and independently of study participation.
    Exclusion Criteria:
    * Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician. * Currently participating in any interventional research studies.

    Protocol Summary

    Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how safe and effective upadacitinib is in treating AD in adolescent and adult Chinese participants.

    Upadacitinib is an approved drug for treating AD. Approximately 200 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in China.

    Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection.

    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
    Peking University Third Hospital /ID# 257722
    Beijing, Beijing Municipality, China, 100191
    Status
    Not applicable
    Location
    The First Affiliated Hospital Of Fujian Medical University /ID# 257725
    Fuzhou, Fujian, China, 350005
    Status
    Not applicable
    Location
    Dermatology Hospital of Southern Medical University /ID# 261862
    Guangzhou, Guangdong, China, 510091
    Status
    Not applicable
    Location
    The Eighth Affiliated Hospital, Sun Yat-sen universtiy /ID# 257737
    Shenzhen, Guangdong, China, 518033
    Status
    Not applicable
    Location
    People's Hospital of Henan Province /ID# 257736
    Zhengzhou, Henan, China, 450003
    Status
    Not applicable
    Location
    Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 257724
    Wuhan, Hubei, China, 430022
    Status
    Not applicable
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