Moderate-to-Severe Atopic Dermatitis Study (18-63 Years)

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)

Study Description

This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response.

The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days.

Brief Summary

This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD.

Condition or Disease

Atopic Dermatitis

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	200
Primary Outcome Measures	Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline
Actual Study Start Date:	June 2024
Estimated Primary Completion Date:	August 2026

Eligibility Criteria

Ages Eligible for Study:	18 Years Old – 63 Years Old
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Atopic Dermatitis

Inclusion Criteria

Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria

Exclusion Criteria

N/A

ADDITIONAL DETAILS

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