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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-08

Study Completion Date

2024-11-02

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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upadacitinib

Adolescents and adults with moderate to severe prurigo-type AD, who are prescribed UPA according to the label and practice in Japan.

No interventions assigned to this group

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No