A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (Flex-Up)

AbbVie Deutschland GmbH & Co. KG63 sites in 7 countries272 target enrollmentSeptember 7, 2023

Overview

Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30 mg QD in subjects who do not achieve Eczema Area and Severity Index (EASI) 90 on upadacitinib 15 mg QD after 12 weeks.
Sub-Study 2 (SS2): The primary study objective for SS2 is to evaluate the efficacy and safety of dose reduction to upadacitinib 15 mg QD in subjects who achieve EASI 90 on upadacitinib 30 mg QD after 12 weeks. No hypothesis testing will be performed in this study.

Registry

euclinicaltrials.eu

Start Date

September 7, 2023

End Date

TBD

Last Updated

last year

Sponsor

Responsible Party

Principal Investigator

Global Clinical Trials Helpdesk

Scientific

AbbVie Deutschland GmbH & Co. KG

•Male or female subjects ≥18 and < 65 years of age at the Screening Visit
•Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
•Candidate for systemic treatment

•Prior exposure to any JAK inhibitor
•Unable or unwilling to discontinue current AD treatments prior to the study
•Requirement of prohibited medications during the study treatment
•Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Achievement of EASI 90 at Week 24

Achievement of EASI 75 / 100 at Week 24.
Achievement of EASI 75 / 90 / 100 at Week 12.
Achievement of EASI 90 and a Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12 and Week 24.
Achievement of a vIGA-AD of 0 or 1 at Week 12.
Achievement of vIGA-AD of 0 or 1 at Week 24.
Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 12.
Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 24.
Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12.
Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24.
Achevement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 12.
Achievement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 24.
Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 12.
Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 24.