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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT03738397
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 76 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Feb 21, 2019
Status verified
Feb 2024
Primary completion
Aug 27, 2020
Completion
Dec 9, 2020

Study Design

Enrollment
673 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib 30 mg QD
    Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.
  • Experimental: Dupilumab 300 mg EOW
    Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.

Primary Outcome Measure

Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (52)

FacilityCityStateZIPSite coordinators
Clinical Research Center AL /ID# 210277BirminghamAlabama35209-6802-
University of Arkansas for Medical Sciences /ID# 211688Little RockArkansas72205-
Tien Q Nguyen MD, Inc /ID# 208934Fountain ValleyCalifornia92708-3701-
UCSF Fresno /ID# 213253FresnoCalifornia93701-2302-
California Allergy and Asthma Medical Group /ID# 213680Los AngelesCalifornia90025-7014-
Dermatology Research Associates /ID# 209097Los AngelesCalifornia90045-
Jonathan Corren, MD. INC /ID# 208987Los AngelesCalifornia90025-4749-
Los Angelos Cataract Center /ID# 208524Los AngelesCalifornia90056-
Dermatology Clinical Trials /ID# 214622Newport BeachCalifornia92660-7853-
UC Davis Health /ID# 209285SacramentoCalifornia95816-
Ucsd /Id# 208990San DiegoCalifornia92103-
Clinical Science Institute /ID# 211022Santa MonicaCalifornia90404-2102-
The Community Research of South Florida /ID# 211145HialeahFlorida33016-1897-
Florida International Rsrch cr /ID# 211562MiamiFlorida33173-
Miami Dermatology and Laser Institute /ID# 212938MiamiFlorida33173-3570-
Progressive Medical Research /ID# 211994Port OrangeFlorida32127-
GCP Research /ID# 216020St. PetersburgFlorida33705-
Clinical Research Trials of Florida, Inc. /ID# 210751TampaFlorida33607-
Integrated Clinical Research LLC /ID# 208831West Palm BeachFlorida33406-6063-
Georgia Pollens Clinical Research Centers, Inc /ID# 211092AlbanyGeorgia31707-1282-
Meridian Clinical Research Dermatology /ID# 213251SavannahGeorgia31406-2632-
Medical Dermatology Associates of Chicago /ID# 210265ChicagoIllinois60654-6903-
Northwestern University Feinberg School of Medicine /ID# 208680ChicagoIllinois60611-2927-
Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058NormalIllinois61761-
Dawes Fretzin, LLC /ID# 209187IndianapolisIndiana46256-
Beacon Clinical Research, LLC /ID# 209280QuincyMassachusetts02169-
Clarkston Skin Research /ID# 208739ClarkstonMichigan48346-
Henry Ford Health System /ID# 208741DetroitMichigan48202-
Clinical Research Institute, Inc /ID# 210852MinneapolisMinnesota55402-2606-
Allergy, Asthma & Immunology Associates, PC /ID# 213481LincolnNebraska68505-2343-
Skin Specialists, PC /ID# 208843OmahaNebraska68144-
Dartmouth-Hitchcock Medical Center /ID# 213727LebanonNew Hampshire03756-
Forest Hills Dermatology Group /ID# 209249Kew GardensNew York11415-
Montefiore Medical Center /ID# 209647The BronxNew York10467-
Wake Forest Univ HS /ID# 208892Winston-SalemNorth Carolina27157-
Univ Hosp Cleveland /ID# 208852ClevelandOhio44106-
The Ohio State University /ID# 209254ColumbusOhio43210-1257-
Southside Dermatology /ID# 212004TulsaOklahoma74132-
Oregon Health and Science University /ID# 208809PortlandOregon97239-
Oregon Medical Res Center PC /ID# 208807PortlandOregon97223-
Medical University of South Carolina /ID# 211054CharlestonSouth Carolina29425-
Clinical Research Solutions, LLC /ID# 212542JacksonTennessee38305-2163-
Orion Clinical Research /ID# 208765AustinTexas78759-4100-
DiscoveResearch, Inc. /ID# 213171BryanTexas77802-
Epiphany Dermatology - Fort Worth /ID# 211187Fort WorthTexas76244-6548-
Sante Clinical Research /ID# 212970KerrvilleTexas78028-9640-
Stephen Miller, MD PA /ID# 210071San AntonioTexas78249-
Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153Sugar LandTexas77479-3153-
University of Utah /ID# 209001Salt Lake CityUtah84112-5500-
Clinical Research Partners, LLC /ID# 212262RichmondVirginia23220-4459-
Premier Clinical Research /ID# 212142SpokaneWashington99202-
West Virginia Research Inst /ID# 212730South CharlestonWest Virginia25309-

Find similar trials in Birmingham, AL

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Clinical Research Center AL· Birmingham, ALUniversity of Arkansas for Medical Sciences· Little Rock, ARTien Q Nguyen MD, Inc· Fountain Valley, CAUCSF Fresno· Fresno, CACalifornia Allergy and Asthma Medical Group· Los Angeles, CADermatology Research Associates· Los Angeles, CA

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