Evaluating the safety and effectiveness of Upadacitinib for adolescents with atopic dermatitis
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)
This study is testing if the oral medication Upadacitinib is safe and effective for teenagers with atopic dermatitis in Japan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | upadacitinib |
| Locations | 59 sites (Asahi Owari, Aichi and 58 other locations) |
| Trial ID | NCT05029895 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of oral Upadacitinib in adolescents aged 12 to under 18 years diagnosed with atopic dermatitis in Japan. Approximately 170 participants will be enrolled from multiple sites, and data will be collected over a period of two years as they receive Upadacitinib as part of their routine clinical care. The study focuses on real-world outcomes, providing insights into the drug's performance in a typical treatment setting without adding any extra burden to participants.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to under 18 years with a diagnosis of atopic dermatitis who are starting treatment with Upadacitinib.
Not a fit: Patients who have previously been treated with Upadacitinib or those for whom the drug is contraindicated may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and effectiveness of Upadacitinib for treating atopic dermatitis in adolescents.
How similar studies have performed: Previous studies have documented the safety and effectiveness of Upadacitinib in adults, but this study is novel as it focuses specifically on adolescents in a real-world setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Prior treatment with upadacitinib * Currently participating in another registrational clinical research study * Participants for whom upadacitinib is contraindicated
Where this trial is running
Asahi Owari, Aichi and 58 other locations
- Takeo Skin Clinic /ID# 248095 — Asahi Owari, Aichi, Japan (Recruiting)
- Ichinomiya Municipal Hospital /ID# 245070 — Ichinomiya-shi, Aichi, Japan (Recruiting)
- Nagoya City University Hospital /ID# 250809 — Nagoya shi, Aichi, Japan (Recruiting)
- NHO Nagoya Medical Center /ID# 245069 — Nagoya-shi, Aichi, Japan (Recruiting)
- Aichi Children's Health and Medical Center /ID# 245357 — Obu-shi, Aichi, Japan (Recruiting)
- Noriko Dermatology Clinic /ID# 246626 — Akita City, Akita, Japan (Recruiting)
- Nippon Medical Chiba Hokusoh Hospital /ID# 246627 — Inzai-shi, Chiba, Japan (Recruiting)
- National Hospital Organization Shimoshizu National Hospital /ID# 245064 — Yotsukaido-shi, Chiba, Japan (Recruiting)
- Matsuyama Red Cross Hospital /ID# 248739 — Matsuyama-shi, Ehime, Japan (Recruiting)
- Fukuoka Children's Hospital /ID# 245067 — Fukuoka City, Fukuoka, Japan (Recruiting)
- Aso Iizuka Hospital /ID# 252145 — Iizuka-shi, Fukuoka, Japan (Recruiting)
- Kurume University Hospital /ID# 248740 — Kurume-shi, Fukuoka, Japan (Recruiting)
- Hoshi General Hospital /ID# 250959 — Koriyama City, Fukushima, Japan (Recruiting)
- Central Japan International Medical Center /ID# 246625 — Minokamo-shi, Gifu, Japan (Recruiting)
- Hiroshima University Hospital /ID# 245356 — Hiroshima-shi, Hiroshima, Japan (Recruiting)
- Kitami Red Cross Hospital /ID# 250838 — Kitami-shi, Hokkaido, Japan (Recruiting)
- Takagi Dermatological Clinic Branch /ID# 241160 — Obihiro-shi, Hokkaido, Japan (Recruiting)
- Hosui General Medical Clinic /ID# 241881 — Sapporo-shi, Hokkaido, Japan (Recruiting)
- Kobayashi Skin Clinic /ID# 248006 — Sapporo, Hokkaido, Japan (Recruiting)
- Hayano Pediatrician Clinic /ID# 250960 — Himeji City, Hyogo, Japan (Recruiting)
- Kobe City Medical Center General Hospital /ID# 244052 — Kobe-shi, Hyogo, Japan (Recruiting)
- Kobe City Medical Center General Hospital /ID# 250836 — Kobe-shi, Hyogo, Japan (Recruiting)
- Bito Dermatology Clinic /ID# 244093 — Kobe-shi, Hyogo, Japan (Recruiting)
- Maekawa Kids Clinic /ID# 249521 — Sichuan, Hyogo, Japan (Recruiting)
- Mito Kyodo General Hospital /ID# 243745 — Mito-shi, Ibaraki, Japan (Recruiting)
- Takeoka Dermatology Clinic /ID# 240610 — Marugame, Kagawa, Japan (Recruiting)
- Kagoshima City Hospital /ID# 252142 — Kagoshima-shi, Kagoshima, Japan (Recruiting)
- Imamura General Hospital /ID# 249526 — Kagoshima-shi, Kagoshima, Japan (Recruiting)
- Kagoshima University Hospital /ID# 248732 — Kagoshima-shi, Kagoshima, Japan (Recruiting)
- Teikyo University Mizonokuchi Hospital /ID# 252146 — Kawasaki, Kanagawa, Japan (Recruiting)
- National Hospital Organization Sagamihara National Hospital /ID# 243744 — Sagamihara-shi, Kanagawa, Japan (Recruiting)
- Kanagawa Children's Medical Center /ID# 252144 — Yokohama-shi, Kanagawa, Japan (Recruiting)
- National Mie Hospital /ID# 245066 — Tsu-shi, Mie, Japan (Recruiting)
- Naha City Hospital /ID# 245065 — Naha, Okinawa, Japan (Recruiting)
- Kansai Medical University Hospital /ID# 246020 — Hirakata-shi, Osaka, Japan (Recruiting)
- Kansai Medical University Medical Center /ID# 250195 — Moriguchi City, Osaka, Japan (Recruiting)
- Japanese Red Cross Osaka Hospital /ID# 249524 — Osaka-shi, Osaka, Japan (Recruiting)
- Osaka Metropolitan University Hospital /ID# 245972 — Osaka-shi, Osaka, Japan (Recruiting)
- Hino Clinic /ID# 245975 — Sakai-shi, Osaka, Japan (Recruiting)
- Osaka Medical and Pharmaceutical University Hospital /ID# 251660 — Takatsuki-shi, Osaka, Japan (Recruiting)
- Okada Kodomonomori Clinic /ID# 248096 — Kasugabe City, Saitama, Japan (Recruiting)
- Saitama Medical Center /ID# 244695 — Kawagoe-shi, Saitama, Japan (Recruiting)
- Dokkyo Medical University Saitama Medical Center /ID# 249525 — Koshigaya, Saitama, Japan (Recruiting)
- Nagahama Red Cross Hospital /ID# 252136 — Nagahama-shi, Shiga, Japan (Recruiting)
- Shiga University of Medical Science Hospital /ID# 245969 — Otsu-shi, Shiga, Japan (Recruiting)
- Chutoen General Medical Center /Id# 248741 — Kakegawa-shi, Shizuoka, Japan (Recruiting)
- Chutoen General Medical Center /Id# 249522 — Kakegawa-shi, Shizuoka, Japan (Recruiting)
- Dokkyo Medical University Hospital /ID# 245068 — Mibu, Tochigi, Japan (Recruiting)
- Tokyo Med Univ Hachioji Med Ct /ID# 250958 — Hachioji-shi, Tokyo, Japan (Recruiting)
- National Center for Child Health and Development /ID# 244696 — Setagaya-ku, Tokyo, Japan (Recruiting)
+9 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.