Real World Study of Oral Upadacitinib Tablets to Assess Adverse Events and Change in Disease Activity in Adolescent and Adult Chinese Participants With Atopic Dermatitis

July 15, 2025 updated by: AbbVie

A Prospective, Multi-center, Post-marketing, Observational Study to Evaluate the Safety and Effectiveness of Upadacitinib in Chinese Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (AD)

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how safe and effective upadacitinib is in treating AD in adolescent and adult Chinese participants.

Upadacitinib is an approved drug for treating AD. Approximately 200 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in China.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital /ID# 257722
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University /ID# 257725
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Dermatology Hospital of Southern Medical University /ID# 261862
      • Shenzhen, Guangdong, China, 518033
        • The Eighth Affiliated Hospital, Sun Yat-sen universtiy /ID# 257737
    • Henan
      • Zhengzhou, Henan, China, 450003
        • People's Hospital of Henan Province /ID# 257736
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 257724
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University /ID# 257641
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Second Affiliated Hospital of Xian Jiaotong University /ID# 257733
    • Shandong
      • Jinan, Shandong, China, 250022
        • Shandong Dermatological Hospital /ID# 257727
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital, Fudan University /ID# 256456
      • Shanghai, Shanghai, China, 200065
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 257726
      • Shanghai, Shanghai, China, 200443
        • Shanghai Skin Disease Hospital /ID# 257719
    • Sichuan
      • Chengdu, Sichuan, China, 610017
        • Chengdu Second Municipal People's Hospital /ID# 257732
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University /ID# 257720
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital /ID# 263898
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Hangzhou First People's Hospital /ID# 261867
      • Hangzhou, Zhejiang, China, 310009
        • The second affiliated hospital of Zhejiang University school of medicine /ID# 257723
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital /ID# 263884

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adolescent and adult Chinese participants with atopic dermatitis (AD) who are prescribed Upadacitinib by their physician according to their local label.

Description

Inclusion Criteria:

  • Diagnosis of moderate to severe atopic dermatitis (AD) at the time of enrollment.
  • Chinese adolescents (≥12 to <18 years of age with body weight of ≥40 kg) or adults (≥18 years of age) at the time of enrollment.
  • Participants eligible for initiation of Upadacitinib treatment for AD, including any required screening tests indicated per China Label.
  • The decision to prescribe Upadacitinib is made prior to and independently of study participation.

Exclusion Criteria:

  • Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician.
  • Currently participating in any interventional research studies.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Upadacitinib
Adolescent and adult participants will receive upadacitinib as prescribed by their physician irrespective of the study participation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Incidence of Serious Infections
Time Frame: Up to approximately 25 months
Incidence rate of serious infections in AD participants treated with Upadacitinib will be assessed.
Up to approximately 25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P21-702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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