Completed

A Post-Marketing Observational Study to Evaluate Safety and Effectiveness of Upadacitinib in Adolescent Patients Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Dermatitis+8

+ Dermatitis, Atopic

+ Hypersensitivity

From 12 to 17 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2021
See protocol details

Summary

Principal SponsorAbbVie
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 29, 2021

Actual date on which the first participant was enrolled.

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to <18 years old in Japan in the real-world setting. Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to <18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan. Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years. 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 and will be asked to provide additional information by questionnaire at each visit.

Official TitleA Post-Marketing Observational Study to Evaluate Safety and Effectiveness of Upadacitinib in Adolescent Patients Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Principal SponsorAbbVie
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

167 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, Inborn

Criteria

Inclusion Criteria: * Participants who are diagnosed with atopic dermatitis (AD). * History of topical anti-inflammatory agents such as topical steroids and topical tacrolimus for AD. * Participants initiating upadacitinib for the treatment of AD in routine clinical practice. * Body weight \>=30 kg at the start of dosing. Exclusion Criteria: * Prior treatment with upadacitinib * Currently participating in another registrational clinical research study * Participants for whom upadacitinib is contraindicated

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 61 locations

Suspended

Takeo Skin Clinic /ID# 248095

Asahi Owari, JapanOpen Takeo Skin Clinic /ID# 248095 in Google Maps
Suspended

Ichinomiya Municipal Hospital /ID# 245070

Ichinomiya-shi, Japan
Suspended

NHO Nagoya Medical Center /ID# 245069

Nagoya, Japan
Suspended

Nagoya City University Hospital /ID# 250809

Nagoya, Japan
Completed61 Study Centers