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

NCT ID: NCT05959083

Last Updated: 2025-07-16

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

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-18

Study Completion Date

2026-06-30

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. 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

Detailed Description

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Conditions

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Atopic Dermatitis (AD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upadacitinib

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Peking University Third Hospital /ID# 257722

Beijing, Beijing Municipality, China

Site Status

The First Affiliated Hospital Of Fujian Medical University /ID# 257725

Fuzhou, Fujian, China

Site Status

Dermatology Hospital of Southern Medical University /ID# 261862

Guangzhou, Guangdong, China

Site Status

The Eighth Affiliated Hospital, Sun Yat-sen universtiy /ID# 257737

Shenzhen, Guangdong, China

Site Status

People's Hospital of Henan Province /ID# 257736

Zhengzhou, Henan, China

Site Status

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 257724

Wuhan, Hubei, China

Site Status

The First Hospital of China Medical University /ID# 257641

Shenyang, Liaoning, China

Site Status

Second Affiliated Hospital of Xian Jiaotong University /ID# 257733

Xi'an, Shaanxi, China

Site Status

Shandong Dermatological Hospital /ID# 257727

Jinan, Shandong, China

Site Status

Huashan Hospital, Fudan University /ID# 256456

Shanghai, Shanghai Municipality, China

Site Status

Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 257726

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Skin Disease Hospital /ID# 257719

Shanghai, Shanghai Municipality, China

Site Status

Chengdu Second Municipal People's Hospital /ID# 257732

Chengdu, Sichuan, China

Site Status

West China Hospital, Sichuan University /ID# 257720

Chengdu, Sichuan, China

Site Status

Sichuan Provincial People's Hospital /ID# 263898

Chengdu, Sichuan, China

Site Status

Hangzhou First People's Hospital /ID# 261867

Hangzhou, Zhejiang, China

Site Status

The second affiliated hospital of Zhejiang University school of medicine /ID# 257723

Hangzhou, Zhejiang, China

Site Status

Ningbo First Hospital /ID# 263884

Ningbo, Zhejiang, China

Site Status

Countries

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China

Related Links

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Other Identifiers

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P21-702

Identifier Type: -

Identifier Source: org_study_id

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