MedPath

Rising Up

Phase 3
Completed
Conditions
Atopic Dermatitis
Registration Number
JPRN-jRCT2080224059
Lead Sponsor
AbbVie GK
Brief Summary

The benefit-risk profile of both doses of upadacitinib in this study is assessed as favorable based on the safety and exploratory efficacy outcomes of the study.

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
272
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
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
safety<br>Number of participants experiencing adverse events
Secondary Outcome Measures
NameTimeMethod
safety<br>-
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