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)

NCT05029895 | Completed

• 1 other identifier: P20-442
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 61

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Atopic Eczema; Upadacitinib; RINVOQ

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Serious Infection

  Serious infection is defined as any infection identified as an Infection Company MedDRA Query that meets seriousness criteria

  2 Years

Secondary Outcomes (10)

• Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) including Safety Specification

  2 Years

• Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) Related to Impact on Bone Growth

  2 Years

• Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1

  2 Years

• Absolute Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)

  Up to 2 Years

• Percent Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)

  Up to 2 Years

Study Arms (1)

Participants Receiving Upadacitinib

Participants receiving upadacitinib for atopic dermatitis.

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent participants receiving upadacitinib according to the product prescribing information for atopic dermatitis in Japan.

You may qualify if:

• 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.

You may not qualify if:

• Prior treatment with upadacitinib
• Currently participating in another registrational clinical research study
• Participants for whom upadacitinib is contraindicated

Sponsors & Collaborators

• AbbVie: lead

Study Sites (61)

Takeo Skin Clinic /ID# 248095

Asahi Owari, Aichi-ken, 488-0032, Japan

Location

Ichinomiya Municipal Hospital /ID# 245070

Ichinomiya-shi, Aichi-ken, 491-8558, Japan

Location

NHO Nagoya Medical Center /ID# 245069

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya City University Hospital /ID# 250809

Nagoya, Aichi-ken, 467-8602, Japan

Location

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

Obu-shi, Aichi-ken, 474-8710, Japan

Location

Noriko Dermatology Clinic /ID# 246626

Akita, Akita, 010-0062, Japan

Location

Nippon Medical Chiba Hokusoh Hospital /ID# 246627

Inzai-shi, Chiba, 270-1613, Japan

Location

National Hospital Organization Shimoshizu National Hospital /ID# 245064

Yotsukaido-shi, Chiba, 284-0003, Japan

Location

Matsuyama Red Cross Hospital /ID# 248739

Matsuyama, Ehime, 790-8524, Japan

Location

Aso Iizuka Hospital /ID# 252145

Iizuka-shi, Fukuoka, 820-8505, Japan

Location

Kurume University Hospital /ID# 248740

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Hoshi General Hospital /ID# 250959

Koriyama-shi, Fukushima, 963-8501, Japan

Location

Central Japan International Medical Center /ID# 246625

Minokamo-shi, Gifu, 505-8510, Japan

Location

Hiroshima University Hospital /ID# 245356

Hiroshima, Hiroshima, 734-8551, Japan

Location

Kitami Red Cross Hospital /ID# 250838

Kitami-shi, Hokkaido, 090-0026, Japan

Location

Takagi Dermatological Clinic /ID# 241160

Obihiro-Shi, Hokkaido, 080-0013, Japan

Location

Hosui General Medical Clinic /ID# 241881

Sapporo, Hokkaido, 060-0063, Japan

Location

Duplicate_Kobayashi Skin Clinic /ID# 248006

Sapporo, Hokkaido, 060-0807, Japan

Location

Hayano Pediatrician Clinic /ID# 250960

Himeji-shi, Hyōgo, 679-2151, Japan

Location

Kobe City Medical Center General Hospital /ID# 244052

Kobe, Hyōgo, 650-0047, Japan

Location

Kobe City Medical Center General Hospital /ID# 250836

Kobe, Hyōgo, 650-0047, Japan

Location

Bito Dermatology Clinic /ID# 244093

Kobe, Hyōgo, 651-0095, Japan

Location

Maekawa Kids Clinic /ID# 249521

Sichuan, Hyōgo, 666-0017, Japan

Location

Mito Kyodo General Hospital /ID# 243745

Mito, Ibaraki, 310-0015, Japan

Location

Torii Dermatology Clinic /ID# 252143

Nonoichi-shi, Ishikawa-ken, 921-8821, Japan

Location

Takeoka Dermatology Clinic /ID# 240610

Marugame, Kagawa-ken, 763-0074, Japan

Location

Kagoshima City Hospital /ID# 252142

Kagoshima, Kagoshima-ken, 673-0886, Japan

Location

Imamura General Hospital /ID# 249526

Kagoshima, Kagoshima-ken, 890-0064, Japan

Location

Kagoshima University Hospital /ID# 248732

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Hiratsuka City Hospital /ID# 245071

Hiratsuka-shi, Kanagawa, 254-0065, Japan

Location

Teikyo University Mizonokuchi Hospital /ID# 252146

Kawasaki, Kanagawa, 213-8507, Japan

Location

National Hospital Organization Sagamihara National Hospital /ID# 243744

Sagamihara-shi, Kanagawa, 252-0392, Japan

Location

Kanagawa Children's Medical Center /ID# 252144

Yokohama, Kanagawa, 232-8555, Japan

Location

National Mie Hospital /ID# 245066

Tsu, Mie-ken, 514-0125, Japan

Location

Okayama University Hospital /ID# 252141

Okayama, Okayama-ken, 700-8558, Japan

Location

Naha City Hospital /ID# 245065

Naha, Okinawa, 902-0061, Japan

Location

Kansai Medical University Hospital /ID# 246020

Hirakata-shi, Osaka, 573-1191, Japan

Location

Kansai Medical University Takii Hospital /ID# 250195

Moriguchi, Osaka, 570-8507, Japan

Location

Duplicate_Japanese Red Cross Osaka Hospital /ID# 249524

Osaka, Osaka, 543-8555, Japan

Location

Osaka Metropolitan University Hospital /ID# 245972

Osaka, Osaka, 545-8586, Japan

Location

Hino Clinic /ID# 245975

Sakai-shi, Osaka, 599-8272, Japan

Location

Osaka Medical and Pharmaceutical University Hospital /ID# 251660

Takatsuki-shi, Osaka, 569-8686, Japan

Location

Okada Kodomonomori Clinic /ID# 248096

Kasukabe-shi, Saitama, 344-0011, Japan

Location

Saitama Medical Center /ID# 244695

Kawagoe, Saitama, 350-8550, Japan

Location

Dokkyo Medical University Saitama Medical Center /ID# 249525

Koshigaya, Saitama, 343-0845, Japan

Location

Nagahama Red Cross Hospital /ID# 252136

Nagahama-shi, Shiga, 526-8585, Japan

Location

Shiga University of Medical Science Hospital /ID# 245969

Ōtsu, Shiga, 520-2192, Japan

Location

Chutoen General Medical Center /Id# 248741

Kakegawa-shi, Shizuoka, 436-0040, Japan

Location

Chutoen General Medical Center /Id# 249522

Kakegawa-shi, Shizuoka, 436-0040, Japan

Location

Dokkyo Medical University Hospital /ID# 245068

Mibu, Tochigi, 321-0293, Japan

Location

Tokyo Med Univ Hachioji Med Ct /ID# 250958

Hachioji-shi, Tokyo, 193-0998, Japan

Location

National Center For Child Health And Development /ID# 244696

Setagaya City, Tokyo, 157-8535, Japan

Location

Tokyo Metropolitan Hiroo Hospital /ID# 250837

Shibuya Ward, Tokyo, 150-0013, Japan

Location

Fraternity Memorial Hospital /ID# 245974

Sumida-ku, Tokyo, 130-8587, Japan

Location

Sugamo Sengoku Dermatology /ID# 247761

Toshima City, Tokyo, 170-0002, Japan

Location

Tonami General Hospital /ID# 247760

Tonami-shi, Toyama, 939-1395, Japan

Location

Suzuki Kids Clinic /ID# 243743

Shingū, Wakayama, 647-0042, Japan

Location

Wakayama Medical University Hospital /ID# 247498

Wakayama, Wakayama, 641-8510, Japan

Location

Yamaguchi Grand Medical Center /ID# 251659

Hohu-shi, Yamaguchi, 747-8511, Japan

Location

Fukuoka Children'S Hospital /ID# 245067

Fukuoka, 813-0017, Japan

Location

Takatsuki General Hospital /ID# 242334

Osaka, Japan

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 1, 2021
• Study Start: September 29, 2021
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

JP (61)