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 Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in the Real World in Japan

Conditions
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Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Upadacitinib<br>Adolescents and adults with moderate to severe prurigo-type AD, who are prescribed UPA according to the label and practice in Japan. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving Worst Pruritus Numerical Rating Scale (WP-NRS) reduction ≥ 4. | WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours in patients with moderate to severe AD, based on the following question: On a scale 0 to 10, with 0 being 'no itch' and 10 being 'worst imaginable itch', how would you rate your itch at its worst during the past 24 hours? | Up to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prurigo Nodularis, Prurigo-type AD, Skin, Dermatology, Upadacitinib, ADMIRE, RINVOQ