A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting

Study Identifier
P21-705
CT.gov Identifier
NCT05139836
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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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:
    * Body weight \>=30 kg at baseline for participants between \>=12 and \<18 years of age. * Physician confirmed diagnosis of moderate to severe atopic dermatitis at the time of enrollment. * Upadacitinib initiated as per the local label. The decision to prescribe upadacitinib must have been made prior to and independently of study participation. * Medical and medication history available at least for the last 6 months.
    Exclusion Criteria:
    \- Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).

    Protocol Summary

    Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with AD. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice.

    Upadacitinib (RINVOQ) is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany.

    Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. The overall duration of the study is approximately 2 years.

    Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

    Study Locations

    Location
    Status
    Location
    Private Practice - Dr. Sung-Hei Hong-Weldemann /ID# 248844
    Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79098
    Status
    Not applicable
    Location
    Durani & Durani, Heidelberg,DE /ID# 249172
    Heidelberg, Baden-Wurttemberg, Germany, 69115
    Status
    Not applicable
    Location
    Universitaetsklinik Heidelberg /ID# 245834
    Heidelberg, Baden-Wurttemberg, Germany, 69120
    Status
    Not applicable
    Location
    Hautarztpraxis Langenau /ID# 242279
    Langenau, Baden-Wurttemberg, Germany, 89129
    Status
    Not applicable
    Location
    Flegl MD Stuttgart Germany /ID# 250302
    Stuttgart, Baden-Wurttemberg, Germany, 70567
    Status
    Not applicable
    Location
    Kurzen, Freising, DE /ID# 241845
    Freising, Bavaria, Germany, 85354
    Status
    Not applicable
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