A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT03607422
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
Jul 27, 2018
Status verified
May 2026
Primary completion
Mar 11, 2021
Completion
Nov 11, 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 Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (76)

FacilityCityStateZIPSite coordinators
Total Skin and Beauty Derm Ctr /ID# 205129BirminghamAlabama35205-
Arizona Research Center, Inc. /ID# 205795PhoenixArizona85053-4061-
Medical Dermatology Specialist /ID# 205516PhoenixArizona85006-2722-
The Dermatology Clinic of Arkansas /ID# 218749BryantArkansas72022-7514-
Arkansas Research Trials /ID# 218469North Little RockArkansas72117-
Encino Research Center /ID# 207472EncinoCalifornia91436-
University of California Irvine /ID# 205136IrvineCalifornia92697-1385-
Ark Clinical Research /ID# 218193Long BeachCalifornia90806-2325-
Keck School of Medicine of USC /ID# 206971Los AngelesCalifornia90033-
Wallace Medical Group /ID# 205701Los AngelesCalifornia90056-
Child Hosp of Orange County,CA /ID# 205735OrangeCalifornia92868-
Palmtree Clinical Research Inc. /Id# 206184Palm SpringsCalifornia92262-
Rady Children's Hospital San Diego /ID# 208244San DiegoCalifornia92123-
Southern California Derma. Inc /ID# 205734Santa AnaCalifornia92701-
Innovative Clinical Research - Lafayette /ID# 208400LafayetteColorado80026-
New England Research Associates, LLC /ID# 206896BridgeportConnecticut06606-1827-
Ideal Clinical Research Inc. /ID# 209880AventuraFlorida33180-
Skin Care Research, LLC /ID# 207099Boca RatonFlorida33486-2269-
Midflorida Clinical Research, Inc. /ID# 213700BrandonFlorida33511-5335-
Clinical Research of West Florida, Inc /ID# 206146ClearwaterFlorida33765-
Revival Research /ID# 208383DoralFlorida33122-1902-
Universal Axon Clinical Research /ID# 213703DoralFlorida33166-
Lakes Research, LLC /ID# 209156MiamiFlorida33014-
Miami Dade Medical Research Institute /ID# 209413MiamiFlorida33176-
Floridian Clinical Research /ID# 207433Miami LakesFlorida33016-1842-
Savin Medical Group, LLC /ID# 206902Miami LakesFlorida33014-2490-
Advanced Research for Health Improvement /ID# 217987NaplesFlorida34102-5430-
Advanced Research for Health Improvement /ID# 218003NaplesFlorida34102-5430-
Complete Health Research /ID# 213459Ormond BeachFlorida32174-6302-
Precision Clinical Research /ID# 207364SunriseFlorida33351-7311-
Clinical Research Trials of Florida, Inc. /ID# 206840TampaFlorida33607-
ForCare Clinical Research /ID# 205120TampaFlorida33613-1244-
Georgia Pollens Clinical Research Centers, Inc /ID# 218567AlbanyGeorgia31707-1282-
Marietta Dermatology Clinical Research /ID# 210317MariettaGeorgia30060-1047-
Agile Clinical Research Trials /ID# 218080Sandy SpringsGeorgia30342-
Treasure Valley Medical Research /ID# 210298BoiseIdaho83706-
Great Lakes Clinical Trials /ID# 205830ChicagoIllinois60640-
Ashira Dermatology /ID# 205512GurneeIllinois60031-3393-
Clinical Investigation Specialists, Inc. /ID# 206898GurneeIllinois60031-
Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135SkokieIllinois60077-
Raga Clinical Studies, LLC. /ID# 206749Crown PointIndiana46307-
Hutchinson Clinic /ID# 205970HutchinsonKansas67502-1131-
Continental Clinical Solutions /ID# 210327TowsonMaryland21204-
Beacon Clinical Research, LLC /ID# 206894QuincyMassachusetts02169-
David Fivenson, MD, PLC /ID# 206903Ann ArborMichigan48103-
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 206895Ann ArborMichigan48109-
Allergy, Asthma & Immunology Associates, PC /ID# 218169LincolnNebraska68505-2343-
Skin Specialists, PC /ID# 205515OmahaNebraska68144-
Duplicate_Summit Medical Group /ID# 213863CliftonNew Jersey07012-1647-
Skin Laser and Surgery Specialists of NY and NJ /ID# 206754HackensackNew Jersey07601-1997-
Care Access Research /ID# 218476HobokenNew Jersey07030-2757-
University of New Mexico School of Medicine /ID# 206756AlbuquerqueNew Mexico87131-0001-
Fordham Dermatology /ID# 218508The BronxNew York10458-5046-
PMG Research of Wilmington LLC /ID# 205968WilmingtonNorth Carolina28401-
University Hospitals Case Medical Center /ID# 206639ClevelandOhio44106-
Awasty Research Network, LLC /ID# 206748MarionOhio43302-6225-
Southside Dermatology /ID# 214451TulsaOklahoma74132-
Vital Prospects Clinical Research Institute, PC /ID# 205824TulsaOklahoma74136-7049-
Cyn3rgy Research /ID# 218064GreshamOregon97030-8316-
Velocity Clinical Research Hallandale Beach /ID# 207544MedfordOregon97504-
Clinical Research Solutions, LLC /ID# 218416JacksonTennessee38305-2163-
Stones River Dermatology /ID# 205178MurfreesboroTennessee37129-3194-
Metroplex Dermatology /ID# 213307ArlingtonTexas76014-3105-
Bellaire Dermatology /ID# 205470BellaireTexas77401-
Center for Clinical Studies /ID# 213186CypressTexas77433-
Dermatology Treatment and Research Center, PA /ID# 205473DallasTexas75230-
Epiphany Dermatology - Fort Worth /ID# 210073Fort WorthTexas76244-6548-
Styde Research, LLC /ID# 213469LewisvilleTexas75067-
Austin Institute for Clinical Research /ID# 206640PflugervilleTexas78660-
Derm Clin Res Ctr San Antonio /ID# 205469San AntonioTexas78229-
EPIC Medical Research /ID# 206382MurrayUtah84123-5632-
Aspen Clinical Research /ID# 208399OremUtah84058-
Timber Lane Allergy & Asthma Research, LLC /ID# 206897South BurlingtonVermont05403-7204-
The Education & Research Foundation, Inc. /ID# 206900LynchburgVirginia24501-1403-
Bellingham Asthma Allergy and Immunology Clinic /ID# 210357BellinghamWashington98225-1945-
Clinical Investigation Specialist, Inc - Kenosha /ID# 215933KenoshaWisconsin53144-1782-

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