Clinical trial NCT03607422: A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)
Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Upadacitinib
ABT-494
Measure Up 2
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 912
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, and a 30-day follow-up visit.

Participants who meet eligibility criteria in the main study will be randomized in a 1:1:1 ratio to receive a daily oral dose of upadacitinib 30 mg or upadacitinib 15 mg or matching placebo. Upon completion of enrollment of a minimum of 810 participants in the main study, a supplemental study will continue to enroll adolescents (adolescent sub-study) until a total of 180 adolescent participants are enrolled overall (main study + adolescent sub-study).

Randomization in the main study will be stratified by baseline disease severity (validated Investigator Global Assessment scale for Atopic Dermatitis \[vIGA-AD\] score of moderate \[3\] versus severe \[4\]), by geographic region (United States \[US\]/Puerto Rico/Canada, and Other), and by age (adolescent \[ages 12 to 17\] versus adult \[ages 18 to 75\]). The separate randomization for the adolescent sub-study will be stratified by baseline disease severity (moderate \[vIGA-AD = 3\] vs. severe \[vIGA-AD = 4\]) and by geographic region (US/Puerto Rico/Canada and Other).

At Week 16 of the main study and the adolescent sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period. In the main study the re-randomization at Week 16 will be stratified by Week 16 50% improvement in Eczema Area and Severity Index \[EASI 50\] responder \[Yes/No\], geographic region \[US/Puerto Rico/Canada, and other\], and age group \[adolescent/adult\]. For the adolescent sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other). Participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose.

Starting at the Week 4 visit, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary.

The Primary Analysis for the main study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the main study and the adolescent sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.

Eligibility criteria: Inclusion Criteria:

* Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and \< 18 years of age
* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
* Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA) affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score ≥ 4.
* Candidate for systemic therapy or have recently required systemic therapy for AD
* Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks

Exclusion Criteria:

* Prior exposure to any Janus kinase (JAK) inhibitor
* Unable or unwilling to discontinue current AD treatments prior to the study
* Requirement of prohibited medications during the study
* Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
* Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Primary outcomes:
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
timeFrame: Baseline and Week 16
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
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 4
measure: Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2
timeFrame: Baseline and Week 2
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 1
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2
timeFrame: Baseline and Day 2
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3
timeFrame: Baseline and Day 3
measure: Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
timeFrame: From first dose of study drug to Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Main Study: Percent Change From Baseline in EASI Score at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16
timeFrame: Week 16
measure: Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 4
measure: Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2
timeFrame: Baseline and Week 2
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 1
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2
timeFrame: Baseline and Day 2
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3
timeFrame: Baseline and Day 3
measure: Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
timeFrame: From first dose of study drug to Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS TSS-7 at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Adolescents: Percent Change From Baseline in EASI Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in POEM Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in DLQI Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percent Change From Baseline in SCORAD Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16
timeFrame: Week 16
measure: Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Derm Ctr /ID# 205129
state: Alabama
city: Phoenix
country: United States
facility: Medical Dermatology Specialist /ID# 205516
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc. /ID# 205795
state: Arizona
city: Bryant
country: United States
facility: The Dermatology Clinic of Arkansas /ID# 218749
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Research Trials /ID# 218469
state: Arkansas
city: Encino
country: United States
facility: Encino Research Center /ID# 207472
state: California
city: Irvine
country: United States
facility: University of California Irvine /ID# 205136
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research /ID# 218193
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC /ID# 206971
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group /ID# 205701
state: California
city: Orange
country: United States
facility: Child Hosp of Orange County,CA /ID# 205735
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research Inc. /Id# 206184
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego /ID# 208244
state: California
city: Santa Ana
country: United States
facility: Southern California Derma. Inc /ID# 205734
state: California
city: Lafayette
country: United States
facility: Innovative Clinical Research - Lafayette /ID# 208400
state: Colorado
city: Bridgeport
country: United States
facility: New England Research Associates, LLC /ID# 206896
state: Connecticut
city: Aventura
country: United States
facility: Ideal Clinical Research Inc. /ID# 209880
state: Florida
city: Boca Raton
country: United States
facility: Skin Care Research, LLC /ID# 207099
state: Florida
city: Brandon
country: United States
facility: Midflorida Clinical Research, Inc. /ID# 213700
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc /ID# 206146
state: Florida
city: Doral
country: United States
facility: Revival Research /ID# 208383
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research /ID# 213703
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group, LLC /ID# 206902
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research /ID# 207433
state: Florida
city: Miami
country: United States
facility: Lakes Research, LLC /ID# 209156
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute /ID# 209413
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement /ID# 217987
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement /ID# 218003
state: Florida
city: Ormond Beach
country: United States
facility: Complete Health Research /ID# 213459
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research /ID# 207364
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc. /ID# 206840
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research /ID# 205120
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc /ID# 218567
state: Georgia
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research /ID# 210317
state: Georgia
city: Sandy Springs
country: United States
facility: Agile Clinical Research Trials /ID# 218080
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research /ID# 210298
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials /ID# 205830
state: Illinois
city: Gurnee
country: United States
facility: Ashira Dermatology /ID# 205512
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc. /ID# 206898
state: Illinois
city: Skokie
country: United States
facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135
state: Illinois
city: Crown Point
country: United States
facility: Raga Clinical Studies, LLC. /ID# 206749
state: Indiana
city: Hutchinson
country: United States
facility: Hutchinson Clinic /ID# 205970
state: Kansas
city: Towson
country: United States
facility: Continental Clinical Solutions /ID# 210327
state: Maryland
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC /ID# 206894
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson, MD, PLC /ID# 206903
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 206895
state: Michigan
city: Lincoln
country: United States
facility: Allergy, Asthma & Immunology Associates, PC /ID# 218169
state: Nebraska
city: Omaha
country: United States
facility: Skin Specialists, PC /ID# 205515
state: Nebraska
city: Clifton
country: United States
facility: Duplicate_Summit Medical Group /ID# 213863
state: New Jersey
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of NY and NJ /ID# 206754
state: New Jersey
city: Hoboken
country: United States
facility: Care Access Research /ID# 218476
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico School of Medicine /ID# 206756
state: New Mexico
city: Bronx
country: United States
facility: Fordham Dermatology /ID# 218508
state: New York
city: Wilmington
country: United States
facility: PMG Research of Wilmington LLC /ID# 205968
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center /ID# 206639
state: Ohio
city: Marion
country: United States
facility: Awasty Research Network, LLC /ID# 206748
state: Ohio
city: Tulsa
country: United States
facility: Southside Dermatology /ID# 214451
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC /ID# 205824
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research /ID# 218064
state: Oregon
city: Medford
country: United States
facility: Velocity Clinical Research Hallandale Beach /ID# 207544
state: Oregon
city: Jackson
country: United States
facility: Clinical Research Solutions, LLC /ID# 218416
state: Tennessee
city: Murfreesboro
country: United States
facility: Stones River Dermatology /ID# 205178
state: Tennessee
city: Arlington
country: United States
facility: Metroplex Dermatology /ID# 213307
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology /ID# 205470
state: Texas
city: Cypress
country: United States
facility: Center for Clinical Studies /ID# 213186
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center, PA /ID# 205473
state: Texas
city: Fort Worth
country: United States
facility: Epiphany Dermatology - Fort Worth /ID# 210073
state: Texas
city: Lewisville
country: United States
facility: Styde Research, LLC /ID# 213469
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research /ID# 206640
state: Texas
city: San Antonio
country: United States
facility: Derm Clin Res Ctr San Antonio /ID# 205469
state: Texas
city: Murray
country: United States
facility: EPIC Medical Research /ID# 206382
state: Utah
city: Orem
country: United States
facility: Aspen Clinical Research /ID# 208399
state: Utah
city: South Burlington
country: United States
facility: Timber Lane Allergy & Asthma Research, LLC /ID# 206897
state: Vermont
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc. /ID# 206900
state: Virginia
city: Bellingham
country: United States
facility: Bellingham Asthma Allergy and Immunology Clinic /ID# 210357
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialist, Inc - Kenosha /ID# 215933
state: Wisconsin
city: Westmead
country: Australia
facility: The Skin Hospital /ID# 217846
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre /ID# 205922
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital /ID# 206023
state: Victoria
city: Clayton
country: Australia
facility: Monash Children's Hospital /ID# 217917
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology /ID# 217791
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 205919
state: Victoria
city: Parkville
country: Australia
facility: Murdoch Children's Research Institute /ID# 205667
state: Victoria
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 206909
state: Niederoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 206573
state: Oberoesterreich
city: Vienna
country: Austria
facility: Klinik Donaustadt /ID# 206572
state: Wien
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 208281
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 205537
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 205181
state: Oost-Vlaanderen
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938
city: Sofia
country: Bulgaria
facility: Medical center Sveti Panteleimon /ID# 210414
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 205292
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital /ID# 205291
city: Sofia
country: Bulgaria
facility: Medical complex Doverie /ID# 211289
city: Edmonton
country: Canada
facility: Stratica Medical /ID# 205415
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre /ID# 205422
state: Alberta
city: Vancouver
country: Canada
facility: UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 207837
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Derm /ID# 206797
state: British Columbia
city: St. John's
country: Canada
facility: Skin Care Studio /ID# 205420
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center /ID# 206333
state: Ontario
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research /ID# 206005
state: Ontario
city: Guelph
country: Canada
facility: Dr. Dusan Sajic Medicine Professional Corporation /ID# 206890
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre /ID# 206772
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Inc. /ID# 206036
state: Ontario
city: Newmarket
country: Canada
facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138
state: Ontario
city: Niagara Falls
country: Canada
facility: Allergy Research Canada Inc. /ID# 213547
state: Ontario
city: Sudbury
country: Canada
facility: Dr. Lyne Giroux Medicine Professional Corporation /ID# 206771
state: Ontario
city: Toronto
country: Canada
facility: Niakosari Medicine Professional Corporation /ID# 206004
state: Ontario
city: Saskatoon
country: Canada
facility: Skinsense Medical Research /ID# 206873
state: Saskatchewan
city: Zagreb
country: Croatia
facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Djecja bolnica Srebrnjak /ID# 205926
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Poliklinika Vlatka Cavka d.o.o. /ID# 211126
state: Grad Zagreb
city: Ivanic-Grad
country: Croatia
facility: Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448
state: Zagrebacka Zupanija
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen /ID# 205096
city: Praha
country: Czechia
facility: Sanatorium profesora Arenbergera /ID# 205098
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 205201
city: Praha
country: Czechia
facility: Fakultni Nemocnice v Motole /ID# 218192
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital /ID# 205524
state: Midtjylland
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital /ID# 205960
state: Sjælland
city: Antony
country: France
facility: Hopital Prive d'Antony /ID# 206553
state: Ile-de-France
city: Bordeaux
country: France
facility: Hopital Saint-Andre /ID# 206554
city: Brest
country: France
facility: CHRU de Brest - Hopital Morvan /ID# 206555
city: Lorient
country: France
facility: C.H. de Bretagne Sud /ID# 206910
city: Paris
country: France
facility: AP-HP - Hopital Saint-Louis /ID# 206552
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 206658
state: Schleswig-Holstein
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt /ID# 207483
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 205767
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207982
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 205765
city: Simmern
country: Germany
facility: Haut- und Laserzentrum Hunsrück /ID# 205768
city: Witten
country: Germany
facility: Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 205766
city: Wuppertal
country: Germany
facility: CentroDerm GmbH /ID# 206861
city: Athens
country: Greece
facility: 251 Airforce General Hospital /ID# 205841
state: Attiki
city: Athens
country: Greece
facility: 401 GSNA - 401 Army General Hospital /ID# 205352
state: Attiki
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 204527
state: Attiki
city: Stavroupoli (Thessalonikis)
country: Greece
facility: Papageorgiou General Hospital Thessaloniki /ID# 204526
state: Thessaloniki
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 218072
state: Borsod-Abauj-Zemplen
city: Gyöngyös
country: Hungary
facility: Bugat Pal Korhaz /ID# 211247
state: Heves
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 205611
state: Somogy
city: Balatonfured
country: Hungary
facility: Drug Research Center /ID# 217855
state: Veszprem
city: Budapest
country: Hungary
facility: Clinexpert Kft /ID# 211246
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft. /ID# 206008
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 205085
city: Dublin 8
country: Ireland
facility: St James Hospital /ID# 204264
state: Dublin
city: Cork
country: Ireland
facility: South Infirmary Victoria University Hospital /ID# 204265
city: Galway
country: Ireland
facility: University Hospital Galway /ID# 209965
city: Waterford
country: Ireland
facility: University Hospital Waterford /ID# 204266
city: Rome
country: Italy
facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 205986
state: Lazio
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 205987
state: Lazio
city: Brescia
country: Italy
facility: ASST Spedali civili di Brescia /ID# 205927
city: Cagliari
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 205168
city: L'Aquila
country: Italy
facility: Presidio Ospedaliero San Salvatore /ID# 205167
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 205169
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital /ID# 206342
state: Gyeonggido
city: Buncheon
country: Korea, Republic of
facility: SoonChunHyang University Buchon Hospital /ID# 206391
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital /ID# 206341
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 206396
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hostipal /ID# 206397
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital /ID# 206343
city: Bergen op Zoom
country: Netherlands
facility: Bravis Ziekenhuis /ID# 206676
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: Centrum Oosterwal /ID# 209640
city: Delft
country: Netherlands
facility: Reinier de Graaf /ID# 205811
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 205162
city: Epsom
country: New Zealand
facility: Greenlane Clinical Centre /ID# 205664
state: Auckland
city: Braga
country: Portugal
facility: CCA Braga - Hospital de Braga /ID# 205854
city: Leiria
country: Portugal
facility: Centro Hospitalar de Leiria, EPE /ID# 209906
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 205839
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas /ID# 205431
city: Porto
country: Portugal
facility: CHP, EPE- Hospital Geral de Sa /ID# 205187
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 205679
city: Singapore
country: Singapore
facility: National Skin Centre /ID# 205222
state: Central Singapore
city: Singapore
country: Singapore
facility: National University Hospital /ID# 205224
city: Singapore
country: Singapore
facility: Singapore General Hospital /ID# 205225
city: Singapore
country: Singapore
facility: KK Women's & Children Hospital /ID# 206693
city: Singapore
country: Singapore
facility: Changi General Hospital /ID# 205223
city: Mieres
country: Spain
facility: Hospital Vital Alvarez Buylla /ID# 205770
state: Asturias
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu /ID# 218047
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 204709
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 210564
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 204712
city: Granada
country: Spain
facility: Hospital Campus de la Salud /ID# 205544
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 204380
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus /ID# 210437
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor /ID# 204710
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia /ID# 210565
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital /ID# 204804
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital /ID# 205092
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 204803
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Ho /ID# 204783
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust /ID# 205711
state: Hampshire
city: Middlesex
country: United Kingdom
facility: Northwick Park Hospital /ID# 205250
state: Harrow
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 206491
state: London, City Of
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993
city: Plymouth
country: United Kingdom
facility: University Hospital Plymouth NHS Trust /ID# 204649
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.
citation: Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Katoh N, Calimlim BM, Thyssen JP, Chiou AS, Bissonnette R, Stein Gold LF, Wegzyn C, Hu X, Liu M, Liu J, Tenorio AR, Chu AD, Guttman-Yassky E. Efficacy and Safety of Upadacitinib in Patients With Moderate to Severe Atopic Dermatitis: Analysis of Follow-up Data From the Measure Up 1 and Measure Up 2 Randomized Clinical Trials. JAMA Dermatol. 2022 Apr 1;158(4):404-413. doi: 10.1001/jamadermatol.2022.0029.
citation: Guttman-Yassky E, Teixeira HD, Simpson EL, Papp KA, Pangan AL, Blauvelt A, Thaci D, Chu CY, Hong HC, Katoh N, Paller AS, Calimlim B, Gu Y, Hu X, Liu M, Yang Y, Liu J, Tenorio AR, Chu AD, Irvine AD. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168. doi: 10.1016/S0140-6736(21)00588-2. Epub 2021 May 21.