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Clinical trial

A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up)

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Last updated:21st Feb 2019
Identifier: NCT03738397

This is a phase 3, randomized, multi-center study that will evaluate upadacitinib versus dupilumab in adults (18-75 years of age) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. The study is comprised of a 35-day screening period, a 24-week blinded treatment period, and a 12-week follow-up period.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date: February 21, 2019
Estimated Primary Completion Date: September 8, 2020
Estimated Study Completion Date: September 8, 2020

Arms:
- Experimental:
Participants administered with upadacitinib
- Experimental: Participants administered with dupilumab

Category Value
Date last updated at source 2019-03-11
Study type(s) Interventional
Expected enrolment 650
Study start date 2019-02-21
Estimated primary completion date 2020-09-08

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