NCT06421740

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

38 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

June 7, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 15, 2024

Last Update Submit

May 11, 2026

Conditions

Keywords

UpadacitinibRinvoq

Outcome Measures

Primary Outcomes (3)

  • Number of participants with a dose change

    Dose change includes: Changed dose, dose escalation or dose tapering.

    12 Months

  • Number of participants with Upadacitinib drug compliance

    The participants missed medication, regardless of reason, or incompliance with the prescription as per medical advice are to be recorded in the eDiary, choosing the reason: "Forgot, Self-reduction of medication, interruption because of AE, interruption not due to safety/tolerability, for other reasons". If no eDiary entries are found within 30 days before the visit, the participant will need to complete the following question in ePRO: timely Upadacitinib intake per medical advice in past 30 days (yes/no); if "no", days-off-drug, intentionally or accidentally, and if "intentionally", reason for incompliance with medical prescription.

    12 Months

  • Number of participants with interruption or permanent discontinuation

    Interruption: Upadacitinib is temporarily interrupted due to atopic dermatitis disease condition, economic, tolerance, AE, or personal reasons, and the investigator considers there is still possibility of Upadacitinib re-initiating within the patient's study follow-up period. Discontinuation: Upadacitinib is permanently discontinued for safety or any other reasons, and the investigator considers Upadacitinib will not be used again, at least within the participant's study follow-up period.

    12 Months

Study Arms (1)

Upadacitinib

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

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Beijing Anzhen Hospital /ID# 273443

Beijing, Beijing Municipality, 100029, China

ACTIVE NOT RECRUITING

China-Japan Friendship Hospital /ID# 274778

Beijing, Beijing Municipality, 100029, China

ACTIVE NOT RECRUITING

Peking University First Hospital /ID# 274865

Beijing, Beijing Municipality, 100034, China

ACTIVE NOT RECRUITING

Peking Unversity Third hospital /ID# 274864

Beijing, Beijing Municipality, 100191, China

ACTIVE NOT RECRUITING

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

Beijing, Beijing Municipality, 100730, China

ACTIVE NOT RECRUITING

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

Fuzhou, Fujian, 350005, China

ACTIVE NOT RECRUITING

Changgeng Hospital /ID# 268209

Xiamen, Fujian, 361022, China

ACTIVE NOT RECRUITING

Guangzhou Dermatology Hospital /ID# 271684

Guangzhou, Guangdong, 510095, China

ACTIVE NOT RECRUITING

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

Zhuhai, Guangdong, 519000, China

ACTIVE NOT RECRUITING

Hainan Fifth People's Hospital /ID# 269747

Hainan, Hainan, 200000, China

ACTIVE NOT RECRUITING

Hebei Engineering University Affiliated Hospital /ID# 268660

Handan, Hebei, 200000, China

ACTIVE NOT RECRUITING

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

Harbin, Heilongjiang, 150001, China

ACTIVE NOT RECRUITING

People's Hospital of Henan Province /ID# 269744

Zhengzhou, Henan, 450003, China

ACTIVE NOT RECRUITING

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

Wuhan, Hubei, 430022, China

ACTIVE NOT RECRUITING

Tongji Hospital /ID# 269745

Wuhan, Hubei, 430030, China

ACTIVE NOT RECRUITING

Xiangya Hospital Central South University /ID# 272373

Changsha, Hunan, 410008, China

ACTIVE NOT RECRUITING

Nanjing Drum Tower Hospital /ID# 268616

Nanjing, Jiangsu, 210008, China

ACTIVE NOT RECRUITING

Affiliated Hospital Of Nantong University /ID# 269743

Nantong, Jiangsu, 226001, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Soochow University /ID# 269742

Suzhou, Jiangsu, 215006, China

ACTIVE NOT RECRUITING

The Affiliated Hospital of Xuzhou Medical College /ID# 268208

Xuzhou, Jiangsu, 221006, China

ACTIVE NOT RECRUITING

Dalian Dermatosis Hospital /ID# 272495

Dalian, Liaoning, 116041, China

ACTIVE NOT RECRUITING

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

Shenyang, Liaoning, 110016, China

COMPLETED

Shandong Provincial Hospital /ID# 268661

Jinan, Shandong, 250001, China

ACTIVE NOT RECRUITING

Jining Medical University - Affiliated Hospital /ID# 270873

Jining, Shandong, 272029, China

ACTIVE NOT RECRUITING

Weifang People'S Hospital /ID# 268659

Weifang, Shandong, 261041, China

ACTIVE NOT RECRUITING

Ruijin Hospital /ID# 268658

Shanghai, Shanghai Municipality, 200025, China

ACTIVE NOT RECRUITING

Huashan Hospital Of Fudan University /ID# 270277

Shanghai, Shanghai Municipality, 200040, China

ACTIVE NOT RECRUITING

Shanghai Sixth People'S Hospital /ID# 268617

Shanghai, Shanghai Municipality, 200233, China

ACTIVE NOT RECRUITING

Shanghai Skin Disease Hospital /ID# 268657

Shanghai, Shanghai Municipality, 200443, China

ACTIVE NOT RECRUITING

West China Hospital of Sichuan University /ID# 268313

Chengdu, Sichuan, 610041, China

ACTIVE NOT RECRUITING

Sichuan Provincial People's Hospital /ID# 268314

Chengdu, Sichuan, 610072, China

RECRUITING

The Affiliated Hospital Of Southwest Medical University /ID# 268207

Luzhou, Sichuan, 646600, China

ACTIVE NOT RECRUITING

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

Ürümqi, Xinjiang, 830001, China

ACTIVE NOT RECRUITING

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

Kunming, Yunnan, 650032, China

ACTIVE NOT RECRUITING

Zhejiang Provincial Hospital of Chinese Medicine /ID# 268613

Hangzhou, Zhejiang, 310006, China

ACTIVE NOT RECRUITING

Ningbo No.6 hospital /ID# 268315

Ningbo, Zhejiang, 315040, China

ACTIVE NOT RECRUITING

Taizhou Central Hospital /ID# 268211

Taizhou, Zhejiang, 318000, China

ACTIVE NOT RECRUITING

Zhuji People'S Hospital /ID# 268614

Zhuji, Zhejiang, 315000, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Central Study Contacts

Judy Yu

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 20, 2024

Study Start

June 7, 2024

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations