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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)
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.
Age
12 - 17 years
Sex
ALL
Healthy Volunteers
No
Takeo Skin Clinic /ID# 248095
Asahi Owari, Aichi-ken, Japan
Ichinomiya Municipal Hospital /ID# 245070
Ichinomiya-shi, Aichi-ken, Japan
NHO Nagoya Medical Center /ID# 245069
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 250809
Nagoya, Aichi-ken, Japan
Aichi Children's Health and Medical Center /ID# 245357
Obu-shi, Aichi-ken, Japan
Noriko Dermatology Clinic /ID# 246626
Akita, Akita, Japan
Nippon Medical Chiba Hokusoh Hospital /ID# 246627
Inzai-shi, Chiba, Japan
National Hospital Organization Shimoshizu National Hospital /ID# 245064
Yotsukaido-shi, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 248739
Matsuyama, Ehime, Japan
Aso Iizuka Hospital /ID# 252145
Iizuka-shi, Fukuoka, Japan
Start Date
September 29, 2021
Primary Completion Date
September 17, 2025
Completion Date
September 17, 2025
Last Updated
February 27, 2026
167
ACTUAL participants
Lead Sponsor
AbbVie
NCT07262983
NCT06389136
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06342713