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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Key facts

Study ID

NCT03738397

Run by

AbbVie

People needed

673

Starts

2019-02-21

Expected to finish

2020-12-09

Last updated by the study team

2024-03-15

Who can join

Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
• Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.

You may not qualify 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.

Where it is running

• University of Arkansas for Medical Sciences /ID# 211688 — Little Rock, Arkansas, United States
• Tien Q Nguyen MD, Inc /ID# 208934 — Fountain Valley, California, United States
• UCSF Fresno /ID# 213253 — Fresno, California, United States
• Jonathan Corren, MD. INC /ID# 208987 — Los Angeles, California, United States
• California Allergy and Asthma Medical Group /ID# 213680 — Los Angeles, California, United States
• Dermatology Research Associates /ID# 209097 — Los Angeles, California, United States
• Los Angelos Cataract Center /ID# 208524 — Los Angeles, California, United States
• Dermatology Clinical Trials /ID# 214622 — Newport Beach, California, United States
• UC Davis Health /ID# 209285 — Sacramento, California, United States
• Ucsd /Id# 208990 — San Diego, California, United States
• Clinical Science Institute /ID# 211022 — Santa Monica, California, United States
• The Community Research of South Florida /ID# 211145 — Hialeah, Florida, United States
• Miami Dermatology and Laser Institute /ID# 212938 — Miami, Florida, United States
• Florida International Rsrch cr /ID# 211562 — Miami, Florida, United States
• Progressive Medical Research /ID# 211994 — Port Orange, Florida, United States
• GCP Research /ID# 216020 — St. Petersburg, Florida, United States
• Clinical Research Trials of Florida, Inc. /ID# 210751 — Tampa, Florida, United States
• Integrated Clinical Research LLC /ID# 208831 — West Palm Beach, Florida, United States
• Georgia Pollens Clinical Research Centers, Inc /ID# 211092 — Albany, Georgia, United States
• Meridian Clinical Research Dermatology /ID# 213251 — Savannah, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 208680 — Chicago, Illinois, United States
• Medical Dermatology Associates of Chicago /ID# 210265 — Chicago, Illinois, United States
• Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058 — Normal, Illinois, United States
• Dawes Fretzin, LLC /ID# 209187 — Indianapolis, Indiana, United States
• Clinical Research Center AL /ID# 210277 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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