Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT03569293
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Key Dates

Start date
Aug 13, 2018
Status verified
Oct 2025
Primary completion
Jan 6, 2021
Completion
Oct 10, 2025

Study Design

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

Arms

  • Placebo Comparator: Placebo / Upadacitinib
    Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260.
  • Experimental: Upadacitinib 15 mg QD
    Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.
  • Experimental: Upadacitinib 30 mg QD
    Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.

Primary Outcome Measure

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

Locations (58)

FacilityCityStateZIPSite coordinators
Alliance Dermatology and MOHs /ID# 200375PhoenixArizona85032-
Clear Dermatology & Aesthetics Center /ID# 201256ScottsdaleArizona85255-4134-
Bakersfield Derma & Skin Cance /ID# 200433BakersfieldCalifornia93309-
First OC Dermatology /ID# 201910Fountain ValleyCalifornia92708-3701-
California Allergy and Asthma Medical Group /ID# 200727Los AngelesCalifornia90025-7014-
Allergy & Asthma Associates of Southern California /ID# 200733Mission ViejoCalifornia92691-6410-
Dermatology Clinical Trials /ID# 205876Newport BeachCalifornia92660-7853-
UC Davis /ID# 203622SacramentoCalifornia95817-
Synergy Dermatology /ID# 200842San FranciscoCalifornia94132-1909-
San Luis Derm and Laser Clinic /ID# 200372San Luis ObispoCalifornia93405-
Stanford University /ID# 200440StanfordCalifornia94305-
Care Access Research - Walnut Creek /ID# 200940Walnut CreekCalifornia94598-2488-
Dermatology Physicians of Connecticut /ID# 200928SheltonConnecticut06484-6211-
Duplicate_George Washington Univ Med /ID# 200364Washington D.C.District of Columbia20037-
Foxhall Research Center /ID# 213682Washington D.C.District of Columbia20016-4300-
Clearlyderm Dermatology /ID# 208371Boca RatonFlorida33428-
Skin Care Research, LLC /ID# 200811Boca RatonFlorida33486-2269-
Olympian Clinical Research /ID# 202914ClearwaterFlorida33756-
Multi-Speciality Research Associates /ID# 213254Lake CityFlorida32055-8835-
GSI Clinical Research, LLC /ID# 200849MargateFlorida33063-
Florida International Rsrch cr /ID# 218507MiamiFlorida33173-
Tory P Sullivan, MD PA /ID# 200671North Miami BeachFlorida33162-4708-
Leavitt Medical Associates of Florida /ID# 200880Ormond BeachFlorida32174-
Precision Clinical Research /ID# 209002SunriseFlorida33351-7311-
Integrated Clinical Research LLC /ID# 200900West Palm BeachFlorida33406-6063-
Christie Clinic, LLC /ID# 200427ChampaignIllinois61820-
Northwestern University Feinberg School of Medicine /ID# 201644ChicagoIllinois60611-2927-
Dawes Fretzin, LLC /ID# 200366IndianapolisIndiana46256-
The South Bend Clinic Center /ID# 200371South BendIndiana46617-
Clinical Trials Management, LLC - Covington /ID# 212658CovingtonLouisiana70433-
Clinical Trials Management, LLC - Metairie /ID# 212659MetairieLouisiana70006-4165-
Northeast Dermatology /ID# 201338BeverlyMassachusetts01915-
Massachusetts General Hospital /ID# 200474BostonMassachusetts02114-
Integrated Dermatology of Massachusetts, LLC /ID# 209468QuincyMassachusetts02169-
Clin Res Inst of Michigan, LLC /ID# 208019ChesterfieldMichigan48047-
Henry Ford Medical Center /ID# 204191DetroitMichigan48202-3046-
Cleaver Dermatology /ID# 202825KirksvilleMissouri63501-5362-
Advanced Dermatology of the Midlands /ID# 201689OmahaNebraska68144-1105-
Clinical Research Consortium /ID# 200734Las VegasNevada89119-5190-
AllCutis Research Inc /ID# 200981PortsmouthNew Hampshire03801-
Forest Hills Dermatology Group /ID# 209244Kew GardensNew York11415-
Icahn School of Medicine at Mount Sinai /ID# 200370New YorkNew York10029-6504-
Montefiore Medical Center /ID# 200456The BronxNew York10467-
J. Schwartz, MD, PLLC /ID# 202121TroyNew York12180-2323-
Velocity clinical research /ID# 202653ClevelandOhio44122-
Lynn Health Science Institute (LHSI) /ID# 212676Oklahoma CityOklahoma73112-
Newton Clinical Research /ID# 204169Oklahoma CityOklahoma73120-5049-
Oregon Health and Science University /ID# 200992PortlandOregon97239-
Oregon Medical Res Center PC /ID# 200428PortlandOregon97223-
Dermdox Dermatology Centers, PC /ID# 213782HazletonPennsylvania18201-
Clinical Partners, LLC /ID# 200460JohnstonRhode Island02919-
Coastal Clinical Research Center of the Carolinas /ID# 200402CharlestonSouth Carolina29414-
Arlington Research Center, Inc /ID# 200391ArlingtonTexas76011-
Orion Clinical Research /ID# 204703AustinTexas78759-4100-
Menter Dermatology Res Inst /ID# 200390DallasTexas75246-
Modern Research Associates, PL /ID# 200705DallasTexas75231-
Center for Clinical Studies - Webster TX /ID# 203185WebsterTexas77598-
Dermatology Specialists of Spokane /ID# 202068SpokaneWashington99202-

Find similar trials in Phoenix, AZ

Related Studies