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)
- Conditions
- Atopic Dermatitis
- Registration Number
- NCT05029895
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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.
- Prior treatment with upadacitinib
- Currently participating in another registrational clinical research study
- Participants for whom upadacitinib is contraindicated
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with Serious Infection 2 Years Serious infection is defined as any infection identified as an Infection Company MedDRA Query that meets seriousness criteria
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving an Improvement in Worst Pruritus-NRS >=4 2 Years Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) including Safety Specification 2 Years An AE/ADR is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. Safety specification is defined as: serious infections (including TB, pneumonia, pneumocystis pneumonia, pulmonary hemorrhage and opportunistic infections), herpes zoster, VTE (deep venous thrombosis and pulmonary embolus), gastrointestinal perforation, hepatic function disorder, Interstitial lung disease, neutrophil count decreased, lymphocyte count decreased and hemoglobin decreased, hepatitis B virus reactivation, malignancies, major adverse cardiac events, rhabdomyolysis and myopathy, and renal impairment, and safety in pediatric patients and weighing \<40 kg.
Absolute Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS) Up to 2 Years Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Percent Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS) Up to 2 Years Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 2 Years The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Absolute Change from Baseline in Patient Oriented Eczema Measure (POEM) Score 2 Years The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale with a higher score denoting worse AD.
Percentage of Participants Achieving a Clinically Meaningful Improvement in POEM 2 Years The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale with a higher score denoting worse AD. Minimal Clinically Important Difference=4
Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) Related to Impact on Bone Growth 2 Years An AE/ADR is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs/treatment-emergent SAEs (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Percentage of Participants Achieving Worst Pruritus-NRS 0/1 2 Years Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Percent Change from Baseline in POEM Score 2 Years The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale with a higher score denoting worse AD.
Trial Locations
- Locations (59)
Kobe City Medical Center General Hospital /ID# 250836
🇯🇵Kobe-shi, Hyogo, Japan
Hosui General Medical Clinic /ID# 241881
🇯🇵Sapporo-shi, Hokkaido, Japan
Takeoka Dermatology Clinic /ID# 240610
🇯🇵Marugame, Kagawa, Japan
Teikyo University Mizonokuchi Hospital /ID# 252146
🇯🇵Kawasaki, Kanagawa, Japan
Kagoshima University Hospital /ID# 248732
🇯🇵Kagoshima-shi, Kagoshima, Japan
National Hospital Organization Sagamihara National Hospital /ID# 243744
🇯🇵Sagamihara-shi, Kanagawa, Japan
Naha City Hospital /ID# 245065
🇯🇵Naha, Okinawa, Japan
Japanese Red Cross Osaka Hospital /ID# 249524
🇯🇵Osaka-shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 251660
🇯🇵Takatsuki-shi, Osaka, Japan
Chutoen General Medical Center /Id# 249522
🇯🇵Kakegawa-shi, Shizuoka, Japan
Shiga University of Medical Science Hospital /ID# 245969
🇯🇵Otsu-shi, Shiga, Japan
Takeo Skin Clinic /ID# 248095
🇯🇵Asahi Owari, Aichi, Japan
Ichinomiya Municipal Hospital /ID# 245070
🇯🇵Ichinomiya-shi, Aichi, Japan
NHO Nagoya Medical Center /ID# 245069
🇯🇵Nagoya-shi, Aichi, Japan
Nagoya City University Hospital /ID# 250809
🇯🇵Nagoya shi, Aichi, Japan
Aichi Children's Health and Medical Center /ID# 245357
🇯🇵Obu-shi, Aichi, Japan
National Hospital Organization Shimoshizu National Hospital /ID# 245064
🇯🇵Yotsukaido-shi, Chiba, Japan
Nippon Medical Chiba Hokusoh Hospital /ID# 246627
🇯🇵Inzai-shi, Chiba, Japan
Noriko Dermatology Clinic /ID# 246626
🇯🇵Akita City, Akita, Japan
Matsuyama Red Cross Hospital /ID# 248739
🇯🇵Matsuyama-shi, Ehime, Japan
Fukuoka Children's Hospital /ID# 245067
🇯🇵Fukuoka City, Fukuoka, Japan
Hoshi General Hospital /ID# 250959
🇯🇵Koriyama City, Fukushima, Japan
Aso Iizuka Hospital /ID# 252145
🇯🇵Iizuka-shi, Fukuoka, Japan
Kurume University Hospital /ID# 248740
🇯🇵Kurume-shi, Fukuoka, Japan
Central Japan International Medical Center /ID# 246625
🇯🇵Minokamo-shi, Gifu, Japan
Kitami Red Cross Hospital /ID# 250838
🇯🇵Kitami-shi, Hokkaido, Japan
Takagi Dermatological Clinic Branch /ID# 241160
🇯🇵Obihiro-shi, Hokkaido, Japan
Hiroshima University Hospital /ID# 245356
🇯🇵Hiroshima-shi, Hiroshima, Japan
Hayano Pediatrician Clinic /ID# 250960
🇯🇵Himeji City, Hyogo, Japan
Kobe City Medical Center General Hospital /ID# 244052
🇯🇵Kobe-shi, Hyogo, Japan
Kobayashi Skin Clinic /ID# 248006
🇯🇵Sapporo, Hokkaido, Japan
Bito Dermatology Clinic /ID# 244093
🇯🇵Kobe-shi, Hyogo, Japan
Maekawa Kids Clinic /ID# 249521
🇯🇵Sichuan, Hyogo, Japan
Mito Kyodo General Hospital /ID# 243745
🇯🇵Mito-shi, Ibaraki, Japan
Kagoshima City Hospital /ID# 252142
🇯🇵Kagoshima-shi, Kagoshima, Japan
Imamura General Hospital /ID# 249526
🇯🇵Kagoshima-shi, Kagoshima, Japan
Kanagawa Children's Medical Center /ID# 252144
🇯🇵Yokohama-shi, Kanagawa, Japan
National Mie Hospital /ID# 245066
🇯🇵Tsu-shi, Mie, Japan
Kansai Medical University Hospital /ID# 246020
🇯🇵Hirakata-shi, Osaka, Japan
Kansai Medical University Medical Center /ID# 250195
🇯🇵Moriguchi City, Osaka, Japan
Osaka Metropolitan University Hospital /ID# 245972
🇯🇵Osaka-shi, Osaka, Japan
Okada Kodomonomori Clinic /ID# 248096
🇯🇵Kasugabe City, Saitama, Japan
Hino Clinic /ID# 245975
🇯🇵Sakai-shi, Osaka, Japan
Saitama Medical Center /ID# 244695
🇯🇵Kawagoe-shi, Saitama, Japan
Chutoen General Medical Center /Id# 248741
🇯🇵Kakegawa-shi, Shizuoka, Japan
Dokkyo Medical University Saitama Medical Center /ID# 249525
🇯🇵Koshigaya, Saitama, Japan
Nagahama Red Cross Hospital /ID# 252136
🇯🇵Nagahama-shi, Shiga, 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-ku, Tokyo, Japan
The Fraternity Memorial Hospital /ID# 245974
🇯🇵Sumida-ku, Tokyo, Japan
Tokyo Metropolitan Hiroo Hospital /ID# 250837
🇯🇵Shibuya Ward, Tokyo, Japan
Sugamo Sengoku Dermatology /ID# 247761
🇯🇵Toshima Ward, Tokyo, Japan
Tonami General Hospital /ID# 247760
🇯🇵Tonami-shi, Toyama, Japan
Suzuki Kids Clinic /ID# 243743
🇯🇵Shingu City, Wakayama, Japan
Yamaguchi Grand Medical Center /ID# 251659
🇯🇵Hohu-shi, Yamaguchi, Japan
Takatsuki General Hospital /ID# 242334
🇯🇵Osaka, Japan
Hiratsuka City Hospital /ID# 245071
🇯🇵Hiratsuka-shi, Japan
Okayama University Hospital /ID# 252141
🇯🇵Okayama, Japan