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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
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

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Noriko Dermatology Clinic /ID# 246626
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AkitaJapanUnknown status
Takeo Skin Clinic /ID# 248095
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Asahi OwariJapanUnknown status
Fukuoka Children'S Hospital /ID# 245067
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FukuokaJapanUnknown status
Tokyo Med Univ Hachioji Med Ct /ID# 250958
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Hachioji-shiJapanUnknown status
Hayano Pediatrician Clinic /ID# 250960
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Himeji-shiJapanUnknown status
Kansai Medical University Hospital /ID# 246020
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Hirakata-shiJapanUnknown status
Hiratsuka City Hospital /ID# 245071
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Hiratsuka-shiJapanUnknown status
Hiroshima University Hospital /ID# 245356
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HiroshimaJapanUnknown status
Yamaguchi Grand Medical Center /ID# 251659
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Hohu-shiJapanUnknown status
Ichinomiya Municipal Hospital /ID# 245070
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Ichinomiya-shiJapanUnknown status
Aso Iizuka Hospital /ID# 252145
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Iizuka-shiJapanUnknown status
Nippon Medical Chiba Hokusoh Hospital /ID# 246627
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Inzai-shiJapanUnknown status
Kagoshima City Hospital /ID# 252142
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KagoshimaJapanUnknown status
Kagoshima University Hospital /ID# 248732
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KagoshimaJapanUnknown status
Imamura General Hospital /ID# 249526
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KagoshimaJapanUnknown status
Chutoen General Medical Center /Id# 248741
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Kakegawa-shiJapanUnknown status
Chutoen General Medical Center /Id# 249522
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Kakegawa-shiJapanUnknown status
Okada Kodomonomori Clinic /ID# 248096
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Kasukabe-shiJapanUnknown status
Saitama Medical Center /ID# 244695
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KawagoeJapanUnknown status
Teikyo University Mizonokuchi Hospital /ID# 252146
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KawasakiJapanUnknown status
Kitami Red Cross Hospital /ID# 250838
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Kitami-shiJapanUnknown status
Kobe City Medical Center General Hospital /ID# 250836
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KobeJapanUnknown status
Kobe City Medical Center General Hospital /ID# 244052
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KobeJapanUnknown status
Bito Dermatology Clinic /ID# 244093
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KobeJapanUnknown status
Hoshi General Hospital /ID# 250959
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Koriyama-shiJapanUnknown status
Dokkyo Medical University Saitama Medical Center /ID# 249525
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KoshigayaJapanUnknown status
Kurume University Hospital /ID# 248740
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Kurume-shiJapanUnknown status
Takeoka Dermatology Clinic /ID# 240610
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MarugameJapanUnknown status
Matsuyama Red Cross Hospital /ID# 248739
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MatsuyamaJapanUnknown status
Dokkyo Medical University Hospital /ID# 245068
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MibuJapanUnknown status
Central Japan International Medical Center /ID# 246625
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Minokamo-shiJapanUnknown status
Mito Kyodo General Hospital /ID# 243745
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MitoJapanUnknown status
Kansai Medical University Takii Hospital /ID# 250195
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MoriguchiJapanUnknown status
Nagahama Red Cross Hospital /ID# 252136
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Nagahama-shiJapanUnknown status
Nagoya City University Hospital /ID# 250809
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NagoyaJapanUnknown status
NHO Nagoya Medical Center /ID# 245069
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NagoyaJapanUnknown status
Naha City Hospital /ID# 245065
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NahaJapanUnknown status
Torii Dermatology Clinic /ID# 252143
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Nonoichi-shiJapanUnknown status
Takagi Dermatological Clinic /ID# 241160
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Obihiro-ShiJapanUnknown status
Aichi Children's Health and Medical Center /ID# 245357
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Obu-shiJapanUnknown status
Okayama University Hospital /ID# 252141
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OkayamaJapanUnknown status
Duplicate_Japanese Red Cross Osaka Hospital /ID# 249524
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OsakaJapanUnknown status
Osaka Metropolitan University Hospital /ID# 245972
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OsakaJapanUnknown status
Takatsuki General Hospital /ID# 242334
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OsakaJapanUnknown status
Shiga University of Medical Science Hospital /ID# 245969
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ŌtsuJapanUnknown status
National Hospital Organization Sagamihara National Hospital /ID# 243744
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Sagamihara-shiJapanUnknown status
Hino Clinic /ID# 245975
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Sakai-shiJapanUnknown status
Duplicate_Kobayashi Skin Clinic /ID# 248006
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SapporoJapanUnknown status
Hosui General Medical Clinic /ID# 241881
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SapporoJapanUnknown status
National Center For Child Health And Development /ID# 244696
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Setagaya CityJapanUnknown status
Tokyo Metropolitan Hiroo Hospital /ID# 250837
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Shibuya WardJapanUnknown status
Suzuki Kids Clinic /ID# 243743
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ShingūJapanUnknown status
Maekawa Kids Clinic /ID# 249521
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SichuanJapanUnknown status
Fraternity Memorial Hospital /ID# 245974
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Sumida-kuJapanUnknown status
Osaka Medical and Pharmaceutical University Hospital /ID# 251660
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Takatsuki-shiJapanUnknown status
Tonami General Hospital /ID# 247760
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Tonami-shiJapanUnknown status
Sugamo Sengoku Dermatology /ID# 247761
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Toshima CityJapanUnknown status
National Mie Hospital /ID# 245066
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TsuJapanUnknown status
Wakayama Medical University Hospital /ID# 247498
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WakayamaJapanUnknown status
Kanagawa Children's Medical Center /ID# 252144
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YokohamaJapanUnknown status
National Hospital Organization Shimoshizu National Hospital /ID# 245064
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Yotsukaido-shiJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.