Atopic Dermatitis (AD) Clinical Trial
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)
| Verified date | April 2024 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Active, not recruiting |
| Enrollment | 200 |
| Est. completion date | June 30, 2026 |
| Est. primary completion date | June 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Peking University Third Hospital /ID# 257722 | Beijing | Beijing |
| China | Chengdu Second Municipal People's Hospital /ID# 257732 | Chengdu | Sichuan |
| China | West China Hospital, Sichuan University /ID# 257720 | Chengdu | Sichuan |
| China | The First Affiliated Hospital Of Fujian Medical University /ID# 257725 | Fuzhou | Fujian |
| China | Dermatology Hospital of Southern Medical University /ID# 261862 | Guangzhou | Guangdong |
| China | Hangzhou First People's Hospital /ID# 261867 | Hangzhou | Zhejiang |
| China | The second affiliated hospital of Zhejiang University school of medicine /ID# 257723 | Hangzhou | Zhejiang |
| China | Shandong Dermatological Hospital /ID# 257727 | Jinan | Shandong |
| China | Huashan Hospital, Fudan University /ID# 256456 | Shanghai | Shanghai |
| China | Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 257726 | Shanghai | Shanghai |
| China | Shanghai Skin Disease Hospital /ID# 257719 | Shanghai | Shanghai |
| China | The First Hospital of China Medical University /ID# 257641 | Shenyang | Liaoning |
| China | The Eighth Affiliated Hospital, Sun Yat-sen universtiy /ID# 257737 | Shenzhen | Guangdong |
| China | Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 257724 | Wuhan | Hubei |
| China | Second Affiliated Hospital of Xian Jiaotong University /ID# 257733 | Xi'an | Shaanxi |
| China | People's Hospital of Henan Province /ID# 257736 | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Incidence of Serious Infections | Incidence rate of serious infections in AD participants treated with Upadacitinib will be assessed. | Up to approximately 25 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03151148 -
Targeted Microbiome Transplant in Atopic Dermatitis
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05456529 -
Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis
|
Phase 3 | |
| Completed |
NCT04056130 -
A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT04173442 -
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
|
||
| Completed |
NCT05372653 -
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
|
Phase 3 | |
| Completed |
NCT03168113 -
Atopic Dermatitis (AD) and Food Allergy
|
N/A | |
| Terminated |
NCT03389893 -
Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis
|
Phase 4 | |
| Recruiting |
NCT04541810 -
A Study of Oral Upadacitinib (RINVOQ) Tablets to Assess Adverse Events and Change in Disease Symptoms in Korean Participants With Moderate to Severe Active Rheumatoid Arthritis, Atopic Dermatitis, Ankylosing Spondylitis or Psoriatic Arthritis
|
||
| Completed |
NCT02357940 -
Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema
|
N/A | |
| Recruiting |
NCT05667623 -
To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD
|
Phase 3 | |
| Recruiting |
NCT05650320 -
To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients With AD
|
Phase 3 | |
| Completed |
NCT01979016 -
Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)
|
Phase 2 | |
| Withdrawn |
NCT04666675 -
A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil
|
Phase 3 | |
| No longer available |
NCT04159597 -
Expanded Access to Upadacitinib
|