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NCT Number: NCT05451316

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

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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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tohoku Medical and Pharmaceuti /ID# 252486

Sendai, Miyagi, 983-0005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of participants achieving Worst Pruritus Numerical Rating Scale (WP-NRS) reduction ≥ 4.

    Time frame: Up to Week 12

    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?"

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: ADMIRE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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