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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Receiving Upadacitinib<br>Participants receiving upadacitinib for atopic dermatitis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RINVOQ, Atopic Dermatitis, Atopic Eczema, Upadacitinib