Summary

for people ages 18-75 (full criteria)
at UC DavisUCSD
study started
estimated completion

Description

Summary

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.

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

Keywords

Atopic Dermatitis Upadacitinib ABT-494 Dupilumab Dermatitis Dermatitis, Atopic Eczema Antibodies, Monoclonal Upadacitinib (ABT-494)

Eligibility

You can join if…

Open to people ages 18-75

  • Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface Area (BSA) and pruritus.
  • Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.

You CAN'T join if...

  • Participant has prior exposure to Janus Kinase (JAK) inhibitor.
  • Participant has prior exposure to dupilumab.
  • Participant is unable or unwilling to discontinue current AD treatments prior to the study.
  • Participant has requirement of prohibited medications during the study.
  • Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
  • Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Locations

  • UC Davis, Dermatology /ID# 209285 not yet accepting patients
    Sacramento California 95816 United States
  • Ucsd /Id# 208990 not yet accepting patients
    San Diego California 92103 United States
  • Jonathan Corren, MD. INC /ID# 208987 accepting new patients
    Los Angeles California 90025-4749 United States
  • Wallace Medical Group, Inc. /ID# 208524 accepting new patients
    Beverly Hills California 90211 United States
  • Clinical Science Institute /ID# 211022 accepting new patients
    Santa Monica California 90404-2102 United States
  • Dermatology Res. Assoc., CA /ID# 209097 accepting new patients
    Los Angeles California 90045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03738397
Phase
Phase 3
Study Type
Interventional
Last Updated