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)

Last updated: June 18, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dermatitis, Atopic

Skin Wounds

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT05029895
P20-442
  • Ages 12-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who are diagnosed with atopic dermatitis (AD).

  • History of topical anti-inflammatory agents such as topical steroids and topicaltacrolimus for AD.

  • Participants initiating upadacitinib for the treatment of AD in routine clinicalpractice.

  • Body weight >=30 kg at the start of dosing.

Exclusion

Exclusion Criteria:

  • Prior treatment with upadacitinib

  • Currently participating in another registrational clinical research study

  • Participants for whom upadacitinib is contraindicated

Study Design

Total Participants: 170
Study Start date:
September 29, 2021
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Takeo Skin Clinic /ID# 248095

    Asahi Owari, Aichi 488-0032
    Japan

    Active - Recruiting

  • Ichinomiya Municipal Hospital /ID# 245070

    Ichinomiya-shi, Aichi 491-8558
    Japan

    Active - Recruiting

  • Nagoya City University Hospital /ID# 250809

    Nagoya shi, Aichi 467-8602
    Japan

    Active - Recruiting

  • NHO Nagoya Medical Center /ID# 245069

    Nagoya-shi, Aichi 460-0001
    Japan

    Active - Recruiting

  • Aichi Children's Health and Medical Center /ID# 245357

    Obu-shi, Aichi 474-8710
    Japan

    Active - Recruiting

  • Noriko Dermatology Clinic /ID# 246626

    Akita City, Akita 010-0062
    Japan

    Active - Recruiting

  • Nippon Medical Chiba Hokusoh Hospital /ID# 246627

    Inzai-shi, Chiba 270-1613
    Japan

    Active - Recruiting

  • National Hospital Organization Shimoshizu National Hospital /ID# 245064

    Yotsukaido-shi, Chiba 284-0003
    Japan

    Active - Recruiting

  • Matsuyama Red Cross Hospital /ID# 248739

    Matsuyama-shi, Ehime 790-8524
    Japan

    Active - Recruiting

  • Fukuoka Children's Hospital /ID# 245067

    Fukuoka City, Fukuoka 813-0017
    Japan

    Active - Recruiting

  • Aso Iizuka Hospital /ID# 252145

    Iizuka-shi, Fukuoka 820-8505
    Japan

    Active - Recruiting

  • Kurume University Hospital /ID# 248740

    Kurume-shi, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Hoshi General Hospital /ID# 250959

    Koriyama City, Fukushima 963-8801
    Japan

    Active - Recruiting

  • Central Japan International Medical Center /ID# 246625

    Minokamo-shi, Gifu 505-8510
    Japan

    Active - Recruiting

  • Hiroshima University Hospital /ID# 245356

    Hiroshima-shi, Hiroshima 734-8551
    Japan

    Active - Recruiting

  • Kitami Red Cross Hospital /ID# 250838

    Kitami-shi, Hokkaido 090-0026
    Japan

    Active - Recruiting

  • Takagi Dermatological Clinic Branch /ID# 241160

    Obihiro-shi, Hokkaido 080-0013
    Japan

    Active - Recruiting

  • Takagi Dermatology Clinic /ID# 241160

    Obihiro-shi, Hokkaido 080-0013
    Japan

    Active - Recruiting

  • Kobayashi Skin Clinic /ID# 248006

    Sapporo, Hokkaido 060-0807
    Japan

    Active - Recruiting

  • Hosui General Medical Clinic /ID# 241881

    Sapporo-shi, Hokkaido 060-0063
    Japan

    Active - Recruiting

  • Hayano Pediatrician Clinic /ID# 250960

    Himeji City, Hyogo 679-2151
    Japan

    Active - Recruiting

  • Bito Dermatology Clinic /ID# 244093

    Kobe-shi, Hyogo 651-0095
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital /ID# 244052

    Kobe-shi, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital /ID# 250836

    Kobe-shi, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Maekawa Kids Clinic /ID# 249521

    Sichuan, Hyogo 666-0017
    Japan

    Active - Recruiting

  • Mito Kyodo General Hospital /ID# 243745

    Mito-shi, Ibaraki 310-0015
    Japan

    Active - Recruiting

  • Takeoka Dermatology Clinic /ID# 240610

    Marugame, Kagawa 763-0074
    Japan

    Active - Recruiting

  • Imamura General Hospital /ID# 249526

    Kagoshima-shi, Kagoshima 890-0064
    Japan

    Active - Recruiting

  • Kagoshima City Hospital /ID# 252142

    Kagoshima-shi, Kagoshima 673-0886
    Japan

    Active - Recruiting

  • Kagoshima University Hospital /ID# 248732

    Kagoshima-shi, Kagoshima 890-8520
    Japan

    Active - Recruiting

  • Teikyo University Mizonokuchi Hospital /ID# 252146

    Kawasaki, Kanagawa 213-8507
    Japan

    Active - Recruiting

  • Teikyo University Hospital, Mizonokuchi /ID# 252146

    Kawasaki City, Kanagawa 213-0002
    Japan

    Site Not Available

  • Teikyo University Hospital, Mizonokuchi /ID# 252146

    Kawasaki-shi, Kanagawa 213-8507
    Japan

    Site Not Available

  • National Hospital Organization Sagamihara National Hospital /ID# 243744

    Sagamihara-shi, Kanagawa 252-0392
    Japan

    Active - Recruiting

  • Kanagawa Children's Medical Center /ID# 252144

    Yokohama-shi, Kanagawa 232-8555
    Japan

    Active - Recruiting

  • National Mie Hospital /ID# 245066

    Tsu-shi, Mie 514-0125
    Japan

    Active - Recruiting

  • Okayama University Hospital /ID# 252141

    Okayama-shi, Okayama 700-8558
    Japan

    Site Not Available

  • Naha City Hospital /ID# 245065

    Naha, Okinawa 902-0061
    Japan

    Active - Recruiting

  • Naha City Hospital /ID# 245065

    Naha-shi, Okinawa 902-8511
    Japan

    Site Not Available

  • Kansai Medical University Hospital /ID# 246020

    Hirakata-shi, Osaka 573-1191
    Japan

    Active - Recruiting

  • Kansai Medical University Medical Center /ID# 250195

    Moriguchi City, Osaka 570-8507
    Japan

    Active - Recruiting

  • Japanese Red Cross Osaka Hospital /ID# 249524

    Osaka-shi, Osaka 543-8555
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital /ID# 245972

    Osaka-shi, Osaka 545-8586
    Japan

    Active - Recruiting

  • Hino Clinic /ID# 245975

    Sakai-shi, Osaka 599-8272
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital /ID# 251660

    Takatsuki-shi, Osaka 569-8686
    Japan

    Active - Recruiting

  • Okada Kodomonomori Clinic /ID# 248096

    Kasugabe City, Saitama 344-0011
    Japan

    Active - Recruiting

  • Saitama Medical Center /ID# 244695

    Kawagoe-shi, Saitama 350-8550
    Japan

    Active - Recruiting

  • Dokkyo Medical University Saitama Medical Center /ID# 249525

    Koshigaya, Saitama 343-0845
    Japan

    Active - Recruiting

  • Dokkyo Medical University Saitama Medical Center /ID# 249525

    Koshigaya-shi, Saitama 343-8555
    Japan

    Site Not Available

  • Nagahama Red Cross Hospital /ID# 252136

    Nagahama-shi, Shiga 526-8585
    Japan

    Active - Recruiting

  • Shiga University of Medical Science Hospital /ID# 245969

    Otsu-shi, Shiga 520-2192
    Japan

    Active - Recruiting

  • Chutoen General Medical Center /Id# 248741

    Kakegawa-shi, Shizuoka 436-0040
    Japan

    Active - Recruiting

  • Chutoen General Medical Center /Id# 249522

    Kakegawa-shi, Shizuoka 436-0040
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital /ID# 245068

    Mibu, Tochigi 321-0293
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital /ID# 245068

    Shimotsuga-gun, Tochigi 321-0293
    Japan

    Site Not Available

  • Tokyo Med Univ Hachioji Med Ct /ID# 250958

    Hachioji-shi, Tokyo 193-0998
    Japan

    Active - Recruiting

  • National Center for Child Health and Development /ID# 244696

    Setagaya-ku, Tokyo 157-8535
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Hiroo Hospital /ID# 250837

    Shibuya Ward, Tokyo 150-0013
    Japan

    Active - Recruiting

  • The Fraternity Memorial Hospital /ID# 245974

    Sumida-ku, Tokyo 1308587
    Japan

    Active - Recruiting

  • Sugamo Sengoku Dermatology /ID# 247761

    Toshima Ward, Tokyo 170-0002
    Japan

    Active - Recruiting

  • Tonami General Hospital /ID# 247760

    Tonami-shi, Toyama 939-1395
    Japan

    Active - Recruiting

  • Suzuki Kids Clinic /ID# 243743

    Shingu City, Wakayama 647-0042
    Japan

    Active - Recruiting

  • Yamaguchi Grand Medical Center /ID# 251659

    Hohu-shi, Yamaguchi 747-8511
    Japan

    Active - Recruiting

  • Hiratsuka City Hospital /ID# 245071

    Hiratsuka-shi, 254-0065
    Japan

    Active - Recruiting

  • Okayama University Hospital /ID# 252141

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Takatsuki General Hospital /ID# 242334

    Osaka,
    Japan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.