An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China

NCT ID: NCT06421740

Last Updated: 2025-08-01

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

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-07

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.

Upadacitinib is an approved drug for treating AD. Approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in China.

Participants will receive oral upadacitinib tablets as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 12 months.

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upadacitinib

Participants will receive upadacitinib as prescribed by their physician according to local label.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adolescents (body weight \>= 40 kg at the Baseline Visit for patients between \>= 12 and \< 18 years of age) and adults at the time of enrollment.
* Clinical diagnosis of moderate to severe atopic dermatitis at the time of enrollment.
* UPA treatment is indicated for AD and prescribed as per Chinese label / SmPC.
* The decision to prescribe UPA is made prior to and independent of study participation.
* The participant should not be treated with UPA prior to this study.
* Participants who are willing and able to participate in the collection of patient-reported data, including ePROs and eDiary via apps.
* The participant (legal representative for adolescents) voluntarily signed an informed consent before any study-related activities are conducted.

Exclusion Criteria

* The participant is currently participating in interventional research (not including noninterventional study, observational study, or registry participation).
* Any circumstances that the investigator believes may limit the patient's participation and compliance with study procedures.
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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Beijing Anzhen Hospital /ID# 273443

Beijing, Beijing Municipality, China

Site Status RECRUITING

China-Japan Friendship Hospital /ID# 274778

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University First Hospital /ID# 274865

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Unversity Third hospital /ID# 274864

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 264193

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital Of Fujian Medical University /ID# 268210

Fuzhou, Fujian, China

Site Status RECRUITING

Changgeng Hospital /ID# 268209

Xiamen, Fujian, China

Site Status RECRUITING

Guangzhou Dermatology Hospital /ID# 271684

Guangzhou, Guangdong, China

Site Status RECRUITING

The Fifth Affiliated Hospital Of Sun Yat-Sen University /ID# 268618

Zhuhai, Guangdong, China

Site Status RECRUITING

Hainan Fifth People's Hospital /ID# 269747

Hainan, Hainan, China

Site Status RECRUITING

Hebei Engineering University Affiliated Hospital /ID# 268660

Handan, Hebei, China

Site Status RECRUITING

The Second Affiliated Hospital Of Harbin Medical University /ID# 270872

Harbin, Heilongjiang, China

Site Status RECRUITING

People's Hospital of Henan Province /ID# 269744

Zhengzhou, Henan, China

Site Status RECRUITING

Wuhan Integrated TCM & Western Medicine Hospital(Wuhan No.1 Hospital) /ID# 272374

Wuhan, Hubei, China

Site Status RECRUITING

Tongji Hospital /ID# 269745

Wuhan, Hubei, China

Site Status RECRUITING

Xiangya Hospital Central South University /ID# 272373

Changsha, Hunan, China

Site Status RECRUITING

Nanjing Drum Tower Hospital /ID# 268616

Nanjing, Jiangsu, China

Site Status RECRUITING

Affiliated Hospital Of Nantong University /ID# 269743

Nantong, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Soochow University /ID# 269742

Suzhou, Jiangsu, China

Site Status RECRUITING

The Affiliated Hospital of Xuzhou Medical College /ID# 268208

Xuzhou, Jiangsu, China

Site Status RECRUITING

Dalian Dermatosis Hospital /ID# 272495

Dalian, Liaoning, China

Site Status RECRUITING

The People's Hospital of Liaoning Province /ID# 268206

Shenyang, Liaoning, China

Site Status COMPLETED

Shandong Provincial Hospital /ID# 268661

Jinan, Shandong, China

Site Status RECRUITING

Jining Medical University - Affiliated Hospital /ID# 270873

Jining, Shandong, China

Site Status RECRUITING

Weifang People'S Hospital /ID# 268659

Weifang, Shandong, China

Site Status RECRUITING

Ruijin Hospital /ID# 268658

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Huashan Hospital Of Fudan University /ID# 270277

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Sixth People'S Hospital /ID# 268617

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Skin Disease Hospital /ID# 268657

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

West China Hospital of Sichuan University /ID# 268313

Chengdu, Sichuan, China

Site Status RECRUITING

Sichuan Provincial People's Hospital /ID# 268314

Chengdu, Sichuan, China

Site Status RECRUITING

The Affiliated Hospital Of Southwest Medical University /ID# 268207

Sichuan, Sichuan, China

Site Status RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region /ID# 269746

Ürümqi, Xinjiang, China

Site Status RECRUITING

The First Affiliated Hospital of Kunming Medical College /ID# 273451

Kunming, Yunnan, China

Site Status RECRUITING

Zhejiang Provincial Hospital of Chinese Medicine /ID# 268613

Hangzhou, Zhejiang, China

Site Status RECRUITING

Ningbo No.6 hospital /ID# 268315

Ningbo, Zhejiang, China

Site Status RECRUITING

Taizhou Central Hospital /ID# 268211

Taizhou, Zhejiang, China

Site Status RECRUITING

Zhuji People'S Hospital /ID# 268614

Zhuji, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Judy Yu

Role: CONTACT

Related Links

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Other Identifiers

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P24-965

Identifier Type: -

Identifier Source: org_study_id

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