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)

Atopic Dermatitis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029895
• Other study ID #: P20-442
• Status: Recruiting
• Start date: September 29, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Japan	Noriko Dermatology Clinic /ID# 246626	Akita City	Akita
Japan	Takeo Skin Clinic /ID# 248095	Asahi Owari	Aichi
Japan	Fukuoka Children's Hospital /ID# 245067	Fukuoka City	Fukuoka
Japan	Tokyo Med Univ Hachioji Med Ct /ID# 250958	Hachioji-shi	Tokyo
Japan	Hayano Pediatrician Clinic /ID# 250960	Himeji City	Hyogo
Japan	Kansai Medical University Hospital /ID# 246020	Hirakata-shi	Osaka
Japan	Hiratsuka City Hospital /ID# 245071	Hiratsuka-shi
Japan	Hiroshima University Hospital /ID# 245356	Hiroshima-shi	Hiroshima
Japan	Yamaguchi Grand Medical Center /ID# 251659	Hohu-shi	Yamaguchi
Japan	Ichinomiya Municipal Hospital /ID# 245070	Ichinomiya-shi	Aichi
Japan	Aso Iizuka Hospital /ID# 252145	Iizuka-shi	Fukuoka
Japan	Nippon Medical Chiba Hokusoh Hospital /ID# 246627	Inzai-shi	Chiba
Japan	Imamura General Hospital /ID# 249526	Kagoshima-shi	Kagoshima
Japan	Kagoshima City Hospital /ID# 252142	Kagoshima-shi	Kagoshima
Japan	Kagoshima University Hospital /ID# 248732	Kagoshima-shi	Kagoshima
Japan	Chutoen General Medical Center /Id# 248741	Kakegawa-shi	Shizuoka
Japan	Chutoen General Medical Center /Id# 249522	Kakegawa-shi	Shizuoka
Japan	Okada Kodomonomori Clinic /ID# 248096	Kasugabe City	Saitama
Japan	Saitama Medical Center /ID# 244695	Kawagoe-shi	Saitama
Japan	Teikyo University Mizonokuchi Hospital /ID# 252146	Kawasaki	Kanagawa
Japan	Kitami Red Cross Hospital /ID# 250838	Kitami-shi	Hokkaido
Japan	Bito Dermatology Clinic /ID# 244093	Kobe-shi	Hyogo
Japan	Kobe City Medical Center General Hospital /ID# 244052	Kobe-shi	Hyogo
Japan	Kobe City Medical Center General Hospital /ID# 250836	Kobe-shi	Hyogo
Japan	Hoshi General Hospital /ID# 250959	Koriyama City	Fukushima
Japan	Dokkyo Medical University Saitama Medical Center /ID# 249525	Koshigaya	Saitama
Japan	Kurume University Hospital /ID# 248740	Kurume-shi	Fukuoka
Japan	Takeoka Dermatology Clinic /ID# 240610	Marugame	Kagawa
Japan	Matsuyama Red Cross Hospital /ID# 248739	Matsuyama-shi	Ehime
Japan	Dokkyo Medical University Hospital /ID# 245068	Mibu	Tochigi
Japan	Central Japan International Medical Center /ID# 246625	Minokamo-shi	Gifu
Japan	Mito Kyodo General Hospital /ID# 243745	Mito-shi	Ibaraki
Japan	Kansai Medical University Medical Center /ID# 250195	Moriguchi City	Osaka
Japan	Nagahama Red Cross Hospital /ID# 252136	Nagahama-shi	Shiga
Japan	Nagoya City University Hospital /ID# 250809	Nagoya shi	Aichi
Japan	NHO Nagoya Medical Center /ID# 245069	Nagoya-shi	Aichi
Japan	Naha City Hospital /ID# 245065	Naha	Okinawa
Japan	Takagi Dermatological Clinic Branch /ID# 241160	Obihiro-shi	Hokkaido
Japan	Aichi Children's Health and Medical Center /ID# 245357	Obu-shi	Aichi
Japan	Okayama University Hospital /ID# 252141	Okayama
Japan	Takatsuki General Hospital /ID# 242334	Osaka
Japan	Japanese Red Cross Osaka Hospital /ID# 249524	Osaka-shi	Osaka
Japan	Osaka Metropolitan University Hospital /ID# 245972	Osaka-shi	Osaka
Japan	Shiga University of Medical Science Hospital /ID# 245969	Otsu-shi	Shiga
Japan	National Hospital Organization Sagamihara National Hospital /ID# 243744	Sagamihara-shi	Kanagawa
Japan	Hino Clinic /ID# 245975	Sakai-shi	Osaka
Japan	Kobayashi Skin Clinic /ID# 248006	Sapporo	Hokkaido
Japan	Hosui General Medical Clinic /ID# 241881	Sapporo-shi	Hokkaido
Japan	National Center for Child Health and Development /ID# 244696	Setagaya-ku	Tokyo
Japan	Tokyo Metropolitan Hiroo Hospital /ID# 250837	Shibuya Ward	Tokyo
Japan	Suzuki Kids Clinic /ID# 243743	Shingu City	Wakayama
Japan	Maekawa Kids Clinic /ID# 249521	Sichuan	Hyogo
Japan	The Fraternity Memorial Hospital /ID# 245974	Sumida-ku	Tokyo
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 251660	Takatsuki-shi	Osaka
Japan	Tonami General Hospital /ID# 247760	Tonami-shi	Toyama
Japan	Sugamo Sengoku Dermatology /ID# 247761	Toshima Ward	Tokyo
Japan	National Mie Hospital /ID# 245066	Tsu-shi	Mie
Japan	Kanagawa Children's Medical Center /ID# 252144	Yokohama-shi	Kanagawa
Japan	National Hospital Organization Shimoshizu National Hospital /ID# 245064	Yotsukaido-shi	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) including Safety Specification	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.	2 Years
Secondary	Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) Related to Impact on Bone Growth	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.	2 Years
Secondary	Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1	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).	2 Years
Secondary	Absolute Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)	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.	Up to 2 Years
Secondary	Percent Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)	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.	Up to 2 Years
Secondary	Percentage of Participants Achieving an Improvement in Worst Pruritus-NRS >=4	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.	2 Years
Secondary	Percentage of Participants Achieving Worst Pruritus-NRS 0/1	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.	2 Years
Secondary	Absolute Change from Baseline in Patient Oriented Eczema Measure (POEM) Score	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.	2 Years
Secondary	Percent Change from Baseline in POEM Score	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.	2 Years
Secondary	Percentage of Participants Achieving a Clinically Meaningful Improvement in POEM	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	2 Years

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.