A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil

Study Overview
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Brief Summary
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Atopic Dermatitis (AD) is a chronic inflammatory skin disease that is characterized by intense itching, oozing and crusting, redness, skin erosion and dry skin. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat participants with moderate to severe AD in Brazil. The study will assess change in disease signs and symptoms. Upadacitinib is an investigational drug being developed for the treatment of Atopic Dermatitis (AD). This study is double-blinded, which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Participants with a diagnosis of AD will be enrolled. Around 150 participants will be enrolled in the study in approximately 20 sites in Brazil. Participants will receive the following for up to 52 weeks: Participants will receive oral upadacitinib tablets once daily for up to week 52. Participants may also receive oral placebo tablets once daily up to week 16 followed by oral upadacitinib tablets once daily up to week 52. Arm 1: Upadacitinib Dose A up to week 52. Arm 2: Upadacitinib Dose B up to week 52. Arm 3: Placebo up to week 16 followed by upadacitinib Dose A up to week 52. Arm 4: Placebo up to week 16 followed by upadacitinib Dose B up to week 52. There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Official Title
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A Phase 3b Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis in Brazil

Conditions
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Atopic Dermatitis (AD)

Intervention / Treatment
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* Drug: Upadacitinib
* Drug: Placebo for Upadacitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight >= 40 kg at the Baseline Visit for participants between >= 12 and < 18 years of age. Chronic Atopic Dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria. Eczema Area and Severity Index (EASI) score >= 16 at the Screening and Baseline Visits. Validated Investigator Global Assessment for AD (vIGA-AD) score ≥ 3 at the Screening and Baseline Visits. >= 10% body surface area of AD involvement at the Screening and Baseline Visits. Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 at Screening and Baseline Visits. Documented history (within 1 year prior to the Screening Visit) of inadequate response (IR) to systemic methotrexate (MTX) and/or cyclosporin A (CsA) or not a candidate for systemic treatment with MTX or CsA as a result of intolerance or medical contraindication. Exclusion Criteria: Prior exposure to any systemic Janus kinase (JAK) inhibitor. Prior exposure to dupilumab. Must not have used the following AD treatments within the specified timeframe prior to Baseline Visit: Corticosteroids, MTX, CsA, azathioprine. phosphodiesterase type 4 (PDE4)-inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks. Targeted biologic treatments (refer to within 5 half-lives [if known]) or within 12 weeks, whichever is longer. Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks. Oral or parenteral traditional medicine within 4 weeks. Moisturizers that contain Topical corticosteroids (TCS), Topical calcineurin inhibitor (TCI)s, or topical Phosphodiesterase type 4 (PDE-4) inhibitors within 7 days.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upadacitinib Dose A<br>Participants will receive Upadacitinib Dose A once daily (QD). | Drug: Upadacitinib<br>* Oral; Tablet<br>* Other names: ABT-494;|
| Experimental: Upadacitinib Dose B<br>Participants will receive Upadacitinib Dose B QD. | Drug: Upadacitinib<br>* Oral; Tablet<br>* Other names: ABT-494;|
| Experimental: Placebo for Upadacitinib Followed by Upadacitinib Dose A<br>Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose A QD. | Drug: Upadacitinib<br>* Oral; Tablet<br>* Other names: ABT-494;Drug: Placebo for Upadacitinib<br>* Oral; Tablet<br>|
| Experimental: Placebo for Upadacitinib Followed by Upadacitinib Dose B<br>Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose B QD. | Drug: Upadacitinib<br>* Oral; Tablet<br>* Other names: ABT-494;Drug: Placebo for Upadacitinib<br>* Oral; Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD). | Baseline to Week 16 | 
| Number of Participants With Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving at least a 90% Reduction in Eczema Area and Severity Index (EASI 90) from Baseline | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. | Baseline to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upadacitinib, Atopic Dermatitis, ABT-494, Rinvoq