A Study to Assess Change in Disease Activity in Adolescents and Adults With Moderate to Severe Prurigo-type Atopic Dermatitis in Japan Who Are Treated With Oral Upadacitinib

Study Identifier
P23-433
CT.gov Identifier
NCT05451316
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 - Atopic Dermatitis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    12+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Physician confirmed diagnosis of moderate to severe atopic dermatitis (AD) at baseline * AD symptom onset \> 1 year prior to baseline * Initiation of UPA treatment for AD is indicated and prescribed per the label in Japan * Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at baseline * Presence of palpable prurigo nodules at baseline
    Exclusion Criteria:
    * Prior treatment with UPA * Contraindications to UPA * Chronic pruritus resulting from another condition (e.g., neuropathic disorders) than AD, prurigo nodularis (PN) * PN caused by medication, metal allergy, infection, insect bite * Current participation in interventional research

    Protocol Summary

    Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Around one-third of patients with AD have had at least 1 incidence of prurigo nodularis (PN), which is characterized by intense, persistent itchy skin and sometimes pain with burning. In this study, the effectiveness of upadacitinib (UPA) will be assessed in participants with prurigo-type AD in a real world (RW) setting in Japan.

    UPA is an approved drug for the treatment of AD. Adults and adolescents who have been diagnosed with prurigo-type AD and prescribed UPA according to the label and practice in Japan will be enrolled in this observational study. The doctor's decision to prescribe UPA will be made prior to and independently of study participation. Approximately 200 participants will be enrolled in the study at 10 sites in Japan.

    Participants will receive extended-release oral tablets of UPA once-daily for 48 weeks.

    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.

    Study Locations

    Location
    Status
    Location
    Tohoku Medical and Pharmaceuti /ID# 252486
    Sendai, Miyagi, Japan, 983-0005
    Status
    Not applicable