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)
NCT ID: NCT05029895
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
167 participants
OBSERVATIONAL
2021-09-29
2025-09-17
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants Receiving Upadacitinib
Participants receiving upadacitinib for atopic dermatitis.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Currently participating in another registrational clinical research study
* Participants for whom upadacitinib is contraindicated
12 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Kurume University Hospital /ID# 248740
Kurume-shi, Fukuoka, Japan
Hoshi General Hospital /ID# 250959
Koriyama-shi, Fukushima, Japan
Central Japan International Medical Center /ID# 246625
Minokamo-shi, Gifu, Japan
Hiroshima University Hospital /ID# 245356
Hiroshima, Hiroshima, Japan
Kitami Red Cross Hospital /ID# 250838
Kitami-shi, Hokkaido, Japan
Takagi Dermatological Clinic /ID# 241160
Obihiro-Shi, Hokkaido, Japan
Hosui General Medical Clinic /ID# 241881
Sapporo, Hokkaido, Japan
Duplicate_Kobayashi Skin Clinic /ID# 248006
Sapporo, Hokkaido, Japan
Hayano Pediatrician Clinic /ID# 250960
Himeji-shi, Hyōgo, Japan
Kobe City Medical Center General Hospital /ID# 244052
Kobe, Hyōgo, Japan
Kobe City Medical Center General Hospital /ID# 250836
Kobe, Hyōgo, Japan
Bito Dermatology Clinic /ID# 244093
Kobe, Hyōgo, Japan
Maekawa Kids Clinic /ID# 249521
Sichuan, Hyōgo, Japan
Mito Kyodo General Hospital /ID# 243745
Mito, Ibaraki, Japan
Torii Dermatology Clinic /ID# 252143
Nonoichi-shi, Ishikawa-ken, Japan
Takeoka Dermatology Clinic /ID# 240610
Marugame, Kagawa-ken, Japan
Kagoshima City Hospital /ID# 252142
Kagoshima, Kagoshima-ken, Japan
Imamura General Hospital /ID# 249526
Kagoshima, Kagoshima-ken, Japan
Kagoshima University Hospital /ID# 248732
Kagoshima, Kagoshima-ken, Japan
Hiratsuka City Hospital /ID# 245071
Hiratsuka-shi, Kanagawa, Japan
Teikyo University Mizonokuchi Hospital /ID# 252146
Kawasaki, Kanagawa, Japan
National Hospital Organization Sagamihara National Hospital /ID# 243744
Sagamihara-shi, Kanagawa, Japan
Kanagawa Children's Medical Center /ID# 252144
Yokohama, Kanagawa, Japan
National Mie Hospital /ID# 245066
Tsu, Mie-ken, Japan
Okayama University Hospital /ID# 252141
Okayama, Okayama-ken, Japan
Naha City Hospital /ID# 245065
Naha, Okinawa, Japan
Kansai Medical University Hospital /ID# 246020
Hirakata-shi, Osaka, Japan
Kansai Medical University Takii Hospital /ID# 250195
Moriguchi, Osaka, Japan
Duplicate_Japanese Red Cross Osaka Hospital /ID# 249524
Osaka, Osaka, Japan
Osaka Metropolitan University Hospital /ID# 245972
Osaka, Osaka, Japan
Hino Clinic /ID# 245975
Sakai-shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 251660
Takatsuki-shi, Osaka, Japan
Okada Kodomonomori Clinic /ID# 248096
Kasukabe-shi, Saitama, Japan
Saitama Medical Center /ID# 244695
Kawagoe, Saitama, Japan
Dokkyo Medical University Saitama Medical Center /ID# 249525
Koshigaya, Saitama, Japan
Nagahama Red Cross Hospital /ID# 252136
Nagahama-shi, Shiga, Japan
Shiga University of Medical Science Hospital /ID# 245969
Ōtsu, Shiga, Japan
Chutoen General Medical Center /Id# 248741
Kakegawa-shi, Shizuoka, Japan
Chutoen General Medical Center /Id# 249522
Kakegawa-shi, Shizuoka, Japan
Dokkyo Medical University Hospital /ID# 245068
Mibu, Tochigi, Japan
Tokyo Med Univ Hachioji Med Ct /ID# 250958
Hachioji-shi, Tokyo, Japan
National Center For Child Health And Development /ID# 244696
Setagaya City, Tokyo, Japan
Tokyo Metropolitan Hiroo Hospital /ID# 250837
Shibuya Ward, Tokyo, Japan
Fraternity Memorial Hospital /ID# 245974
Sumida-ku, Tokyo, Japan
Sugamo Sengoku Dermatology /ID# 247761
Toshima City, Tokyo, Japan
Tonami General Hospital /ID# 247760
Tonami-shi, Toyama, Japan
Suzuki Kids Clinic /ID# 243743
Shingū, Wakayama, Japan
Wakayama Medical University Hospital /ID# 247498
Wakayama, Wakayama, Japan
Yamaguchi Grand Medical Center /ID# 251659
Hohu-shi, Yamaguchi, Japan
Fukuoka Children'S Hospital /ID# 245067
Fukuoka, , Japan
Takatsuki General Hospital /ID# 242334
Osaka, , Japan
Countries
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Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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P20-442
Identifier Type: -
Identifier Source: org_study_id