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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05959083

Enrollment

200

Registered

2023-07-25

Start date

2023-08-18

Completion date

2026-05-07

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis (AD)

Keywords

Atopic Dermatitis (AD), Upadacitinib, RINVOQ

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results