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CompletedNCT05451316ADMIREUpdated Feb 27, 2026

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

An observational study in Atopic Dermatitis, sponsored by AbbVie. Completed at 1 site in Japan. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by AbbVie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
12 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Atopic Dermatitis

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Keywords

  • Prurigo Nodularis
  • Prurigo-type AD
  • Skin
  • Dermatology
  • Upadacitinib
  • ADMIRE
  • RINVOQ
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 1 is below the median of 150 across 237 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adolescents and adults, age ≥ 12 years, with a physician-confirmed diagnosis of atopic dermatitis (AD), who are prescribed UPA according to the label and practice in Japan. The decision to prescribe UPA will be made prior to and independent of study 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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)

Groups and cohorts

  • Upadacitinib

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

06

What researchers measure

Primary outcomes

  1. 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?"

    Time frame: Up to Week 12

07

Study locations

1 site
  • Tohoku Medical and Pharmaceuti /ID# 252486
    Sendai, Miyagi 983-0005, Japan
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05451316
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jul 11, 2022
Start date
Dec 8, 2022
Primary completion
Nov 2, 2024
Completion
Nov 2, 2024
Last update
Feb 27, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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