A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Official Title
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A Phase 3 Randomized, Multicenter, Double-Blind Study to Evaluate the Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects in Japan With Moderate to Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Upadacitinib
* Drug: Placebo for upadacitinib
* Drug: Topical Corticosteroids (TCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus. Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis. Able to tolerate topical corticosteroids for atopic dermatitis lesions. Exclusion Criteria: Prior exposure to any Janus kinase (JAK) inhibitor. Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study. Requirement of prohibited medications during the study. Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

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: Arm A<br>Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS). | Drug: Upadacitinib<br>* Upadacitinib is administered orally.<br>* Other names: ABT-494;Drug: Topical Corticosteroids (TCS)<br>* It is administered concomitantly with upadacitinib or placebo.<br>|
| Experimental: Arm B<br>Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS). | Drug: Upadacitinib<br>* Upadacitinib is administered orally.<br>* Other names: ABT-494;Drug: Topical Corticosteroids (TCS)<br>* It is administered concomitantly with upadacitinib or placebo.<br>|
| Experimental: Arm C<br>Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS. | Drug: Upadacitinib<br>* Upadacitinib is administered orally.<br>* Other names: ABT-494;Drug: Placebo for upadacitinib<br>* Placebo is administered orally.<br>Drug: Topical Corticosteroids (TCS)<br>* It is administered concomitantly with upadacitinib or placebo.<br>|
| Experimental: Arm D<br>Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS. | Drug: Upadacitinib<br>* Upadacitinib is administered orally.<br>* Other names: ABT-494;Drug: Placebo for upadacitinib<br>* Placebo is administered orally.<br>Drug: Topical Corticosteroids (TCS)<br>* It is administered concomitantly with upadacitinib or placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing adverse events | Adverse events are defined as those that began or worsened in severity after the first dose of study drug but within 30 days after the last dose of study drug. | Up to 141 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upadacitinib, Topical Corticosteroids, Atopic Dermatitis