NCT05029895Completed
A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
A Post-Marketing Observational Study to Evaluate Safety and Effectiveness of Upadacitinib in Adolescent Patients Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to \<18 years old in Japan in the real-world setting. Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to \<18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan. Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 167 (actual)
- First submitted
- 30 Aug 2021
- Start date
- Sept 2021
- Primary completion date
- Sept 2025
- Lead sponsor
- AbbVie
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05029895
What you commit to
- Study type: Observational
- Participants enrolled: 167
- From Sept 2021 to the primary completion date, Sept 2025
- 61 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with upadacitinib
Other
- Currently participating in another registrational clinical research study
- Participants for whom upadacitinib is contraindicated
Who the study is looking for
- Participants who are diagnosed with atopic dermatitis (AD).
- History of topical anti-inflammatory agents such as topical steroids and topical tacrolimus for AD.
- Participants initiating upadacitinib for the treatment of AD in routine clinical practice.
- Body weight \>=30 kg at the start of dosing.
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noriko Dermatology Clinic /ID# 246626 Coordinator of this site? Confirm its status | Akita | Japan | Unknown status |
| Takeo Skin Clinic /ID# 248095 Coordinator of this site? Confirm its status | Asahi Owari | Japan | Unknown status |
| Fukuoka Children'S Hospital /ID# 245067 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Tokyo Med Univ Hachioji Med Ct /ID# 250958 Coordinator of this site? Confirm its status | Hachioji-shi | Japan | Unknown status |
| Hayano Pediatrician Clinic /ID# 250960 Coordinator of this site? Confirm its status | Himeji-shi | Japan | Unknown status |
| Kansai Medical University Hospital /ID# 246020 Coordinator of this site? Confirm its status | Hirakata-shi | Japan | Unknown status |
| Hiratsuka City Hospital /ID# 245071 Coordinator of this site? Confirm its status | Hiratsuka-shi | Japan | Unknown status |
| Hiroshima University Hospital /ID# 245356 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Yamaguchi Grand Medical Center /ID# 251659 Coordinator of this site? Confirm its status | Hohu-shi | Japan | Unknown status |
| Ichinomiya Municipal Hospital /ID# 245070 Coordinator of this site? Confirm its status | Ichinomiya-shi | Japan | Unknown status |
| Aso Iizuka Hospital /ID# 252145 Coordinator of this site? Confirm its status | Iizuka-shi | Japan | Unknown status |
| Nippon Medical Chiba Hokusoh Hospital /ID# 246627 Coordinator of this site? Confirm its status | Inzai-shi | Japan | Unknown status |
| Kagoshima City Hospital /ID# 252142 Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Kagoshima University Hospital /ID# 248732 Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Imamura General Hospital /ID# 249526 Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Chutoen General Medical Center /Id# 248741 Coordinator of this site? Confirm its status | Kakegawa-shi | Japan | Unknown status |
| Chutoen General Medical Center /Id# 249522 Coordinator of this site? Confirm its status | Kakegawa-shi | Japan | Unknown status |
| Okada Kodomonomori Clinic /ID# 248096 Coordinator of this site? Confirm its status | Kasukabe-shi | Japan | Unknown status |
| Saitama Medical Center /ID# 244695 Coordinator of this site? Confirm its status | Kawagoe | Japan | Unknown status |
| Teikyo University Mizonokuchi Hospital /ID# 252146 Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| Kitami Red Cross Hospital /ID# 250838 Coordinator of this site? Confirm its status | Kitami-shi | Japan | Unknown status |
| Kobe City Medical Center General Hospital /ID# 250836 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Kobe City Medical Center General Hospital /ID# 244052 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Bito Dermatology Clinic /ID# 244093 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Hoshi General Hospital /ID# 250959 Coordinator of this site? Confirm its status | Koriyama-shi | Japan | Unknown status |
| Dokkyo Medical University Saitama Medical Center /ID# 249525 Coordinator of this site? Confirm its status | Koshigaya | Japan | Unknown status |
| Kurume University Hospital /ID# 248740 Coordinator of this site? Confirm its status | Kurume-shi | Japan | Unknown status |
| Takeoka Dermatology Clinic /ID# 240610 Coordinator of this site? Confirm its status | Marugame | Japan | Unknown status |
| Matsuyama Red Cross Hospital /ID# 248739 Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Dokkyo Medical University Hospital /ID# 245068 Coordinator of this site? Confirm its status | Mibu | Japan | Unknown status |
| Central Japan International Medical Center /ID# 246625 Coordinator of this site? Confirm its status | Minokamo-shi | Japan | Unknown status |
| Mito Kyodo General Hospital /ID# 243745 Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Kansai Medical University Takii Hospital /ID# 250195 Coordinator of this site? Confirm its status | Moriguchi | Japan | Unknown status |
| Nagahama Red Cross Hospital /ID# 252136 Coordinator of this site? Confirm its status | Nagahama-shi | Japan | Unknown status |
| Nagoya City University Hospital /ID# 250809 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| NHO Nagoya Medical Center /ID# 245069 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Naha City Hospital /ID# 245065 Coordinator of this site? Confirm its status | Naha | Japan | Unknown status |
| Torii Dermatology Clinic /ID# 252143 Coordinator of this site? Confirm its status | Nonoichi-shi | Japan | Unknown status |
| Takagi Dermatological Clinic /ID# 241160 Coordinator of this site? Confirm its status | Obihiro-Shi | Japan | Unknown status |
| Aichi Children's Health and Medical Center /ID# 245357 Coordinator of this site? Confirm its status | Obu-shi | Japan | Unknown status |
| Okayama University Hospital /ID# 252141 Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Duplicate_Japanese Red Cross Osaka Hospital /ID# 249524 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka Metropolitan University Hospital /ID# 245972 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Takatsuki General Hospital /ID# 242334 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Shiga University of Medical Science Hospital /ID# 245969 Coordinator of this site? Confirm its status | Ōtsu | Japan | Unknown status |
| National Hospital Organization Sagamihara National Hospital /ID# 243744 Coordinator of this site? Confirm its status | Sagamihara-shi | Japan | Unknown status |
| Hino Clinic /ID# 245975 Coordinator of this site? Confirm its status | Sakai-shi | Japan | Unknown status |
| Duplicate_Kobayashi Skin Clinic /ID# 248006 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Hosui General Medical Clinic /ID# 241881 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| National Center For Child Health And Development /ID# 244696 Coordinator of this site? Confirm its status | Setagaya City | Japan | Unknown status |
| Tokyo Metropolitan Hiroo Hospital /ID# 250837 Coordinator of this site? Confirm its status | Shibuya Ward | Japan | Unknown status |
| Suzuki Kids Clinic /ID# 243743 Coordinator of this site? Confirm its status | Shingū | Japan | Unknown status |
| Maekawa Kids Clinic /ID# 249521 Coordinator of this site? Confirm its status | Sichuan | Japan | Unknown status |
| Fraternity Memorial Hospital /ID# 245974 Coordinator of this site? Confirm its status | Sumida-ku | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital /ID# 251660 Coordinator of this site? Confirm its status | Takatsuki-shi | Japan | Unknown status |
| Tonami General Hospital /ID# 247760 Coordinator of this site? Confirm its status | Tonami-shi | Japan | Unknown status |
| Sugamo Sengoku Dermatology /ID# 247761 Coordinator of this site? Confirm its status | Toshima City | Japan | Unknown status |
| National Mie Hospital /ID# 245066 Coordinator of this site? Confirm its status | Tsu | Japan | Unknown status |
| Wakayama Medical University Hospital /ID# 247498 Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Kanagawa Children's Medical Center /ID# 252144 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| National Hospital Organization Shimoshizu National Hospital /ID# 245064 Coordinator of this site? Confirm its status | Yotsukaido-shi | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.