Atopic Dermatitis (AD)NCT05959083
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
An observational study of Atopic Dermatitis (AD), run by AbbVie at 18 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis (AD)
- How many people
- 200 participants
- Where
- 18 sitesChina
- Study dates
- 18 Aug 2023to 7 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adolescent and adult Chinese participants with atopic dermatitis (AD) who are prescribed Upadacitinib by their physician according to their local label.
Who may be able to join
- 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.
Who cannot join
- Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician.
- Currently participating in any interventional research studies.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Peking University Third Hospital /ID# 257722
Beijing, Beijing Municipality, 100191
Chengdu Second Municipal People's Hospital /ID# 257732
Chengdu, Sichuan, 610017
West China Hospital, Sichuan University /ID# 257720
Chengdu, Sichuan, 610041
Sichuan Provincial People's Hospital /ID# 263898
Chengdu, Sichuan, 610072
The First Affiliated Hospital Of Fujian Medical University /ID# 257725
Fuzhou, Fujian, 350005
Dermatology Hospital of Southern Medical University /ID# 261862
Guangzhou, Guangdong, 510091
Hangzhou First People's Hospital /ID# 261867
Hangzhou, Zhejiang, 310003
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 257723
Hangzhou, Zhejiang, 310009
Shandong Dermatological Hospital /ID# 257727
Jinan, Shandong, 250022
Ningbo First Hospital /ID# 263884
Ningbo, Zhejiang, 315010
Huashan Hospital, Fudan University /ID# 256456
Shanghai, Shanghai Municipality, 200040
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 257726
Shanghai, Shanghai Municipality, 200065
Shanghai Skin Disease Hospital /ID# 257719
Shanghai, Shanghai Municipality, 200443
First Affiliated Hospital of China Medical University /ID# 257641
Shenyang, Liaoning, 110001
The Eighth Affiliated Hospital, Sun Yat-sen universtiy /ID# 257737
Shenzhen, Guangdong, 518033
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 257724
Wuhan, Hubei, 430022
Second Affiliated Hospital of Xian Jiaotong University /ID# 257733
Xi'an, Shaanxi, 710004
People's Hospital of Henan Province /ID# 257736
Zhengzhou, Henan, 450003
About this study
Official title: 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.
Read more
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
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis (AD), Upadacitinib, RINVOQ
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib | Adolescent and adult participants will receive upadacitinib as prescribed by their physician irrespective of the study participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Incidence of Serious Infections
Incidence rate of serious infections in AD participants treated with Upadacitinib will be assessed.
Measured: Up to approximately 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start18 Aug 2023
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959083
- Sponsor's protocol ID
- P21-702
- Status last verified
- Nov 2026
- First submitted
- 17 Jul 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05959083
- Acronym / sponsor ID
- P21-702
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis (AD), Upadacitinib, RINVOQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib | – | –Adolescent and adult participants will receive upadacitinib as prescribed by their physician irrespective of the study participation. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescent and adult Chinese participants with atopic dermatitis (AD) who are prescribed Upadacitinib by their physician according to their local label.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician.
- Currently participating in any interventional research studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis (AD), run by AbbVie at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Incidence of Serious Infections (time frame: Up to approximately 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.