Clinical Trial Details for

A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis (Measure Up 2)

NCT ID: NCT03607422

Last Updated: August 27, 2020

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

Purpose

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 AD who are candidates for systemic therapy.

The Study at a Glance

Status: Recruiting

Phase: Phase 3

Gender: All

Age: 12 Years - 75 Years

Condition: Atopic Dermatitis

Study Type: Interventional

Lead Sponsor: AbbVie

Eligibility

Ages Eligible for Study: 12 Years to 75 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria: - Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years of age - Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline - Active moderate to severe AD defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus - 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

Additional Information, Locations & Contacts

Collaborators: Not provided

Investigators: AbbVie Inc.

Please refer to this study by its clinicaltrials.gov identifier: NCT03607422
Location

Total Skin and Beauty Derm Ctr /ID# 205129

Birmingham, Alabama, United States

Medical Dermatology Specialist /ID# 205516

Phoenix, Arizona, United States

Arizona Research Center, Inc. /ID# 205795

Phoenix, Arizona, United States

Dermatology Trial Associate /ID# 218749

Bryant, Arkansas, United States

Arkansas Research Trials /ID# 218469

North Little Rock, Arkansas, United States

Wallace Medical Group, Inc. /ID# 205701

Beverly Hills, California, United States

Encino Research Center / T. Jo /ID# 207472

Encino, California, United States

University of California Irvine /ID# 205136

Irvine, California, United States

Ark Clinical Research /ID# 218193

Long Beach, California, United States

Keck School of Medicine of USC /ID# 206971

Los Angeles, California, United States

Child Hosp of Orange County,CA /ID# 205735

Orange, California, United States

Palmtree Clinical Research Inc. /Id# 206184

Palm Springs, California, United States

UCSD Rady's Children's Hospital /ID# 208244

San Diego, California, United States

Southern California Derma. Inc /ID# 205734

Santa Ana, California, United States

Innovative Clinical Research - Lafayette /ID# 208400

Lafayette, Colorado, United States

New England Research Associates, LLC /ID# 206896

Bridgeport, Connecticut, United States

Ideal Clinical Research Inc. /ID# 209880

Aventura, Florida, United States

Skin Care Research, LLC /ID# 207099

Boca Raton, Florida, United States

Midflorida Clinical Research, Inc. /ID# 213700

Brandon, Florida, United States

Clinical Res of West FL, Inc. /ID# 206146

Clearwater, Florida, United States

Revival Research /ID# 208383

Doral, Florida, United States

Universal Axon Clinical Resear /ID# 213703

Doral, Florida, United States

Floridian Clinical Research /ID# 207433

Hialeah, Florida, United States

Savin Medical Group, LLC /ID# 206902

Miami Lakes, Florida, United States

Lakes Research, LLC /ID# 209156

Miami, Florida, United States

Miami Dade Medical Research In /ID# 209413

Miami, Florida, United States

Advanced Research for Health Improvement /ID# 217987

Naples, Florida, United States

Advanced Research for Health Improvement /ID# 218003

Naples, Florida, United States

Ormond Medical Arts Pharmaceutical Research Center /ID# 213459

Ormond Beach, Florida, United States

Precision Clinical Research /ID# 207364

Sunrise, Florida, United States

Clinical Research Trials of Florida, Inc. /ID# 206840

Tampa, Florida, United States

ForCare Clinical Research /ID# 205120

Tampa, Florida, United States

Georgia Pollens Clinical Research Centers, Inc /ID# 218567

Albany, Georgia, United States

Marietta Dermatology Clinical Research /ID# 210317

Marietta, Georgia, United States

Agile Clinical Research Trials /ID# 218080

Sandy Springs, Georgia, United States

Treasure Valley Medical Research /ID# 210298

Boise, Idaho, United States

Great Lakes Clinical Trials /ID# 205830

Chicago, Illinois, United States

Northshore University Health System-Evanston /ID# 205135

Evanston, Illinois, United States

Ashira Dermatology /ID# 205512

Gurnee, Illinois, United States

Clinical Investigation Specialists, Inc. /ID# 206898

Gurnee, Illinois, United States

Raga Clinical Studies, LLC. /ID# 206749

Crown Point, Indiana, United States

Hutchinson Clinic /ID# 205970

Hutchinson, Kansas, United States

Continental Clinical Solutions /ID# 210327

Towson, Maryland, United States

Beacon Clinical Research, LLC /ID# 206894

Quincy, Massachusetts, United States

David Fivenson, MD, PLC /ID# 206903

Ann Arbor, Michigan, United States

University of Michigan Health Systems /ID# 206895

Ann Arbor, Michigan, United States

Allergy, Asthma & Immunology Associates, PC /ID# 218169

Lincoln, Nebraska, United States

Skin Specialists, PC /ID# 205515

Omaha, Nebraska, United States

Summit Medical Group /ID# 213863

Clifton, New Jersey, United States

Skin Laser and Surgery Specialists of NY and NJ /ID# 206754

Hackensack, New Jersey, United States

Care Access Research, Hoboken /ID# 218476

Hoboken, New Jersey, United States

University of New Mexico School of Medicine /ID# 206756

Albuquerque, New Mexico, United States

Fordham Dermatology /ID# 218508

Bronx, New York, United States

PMG Research of Wilmington LLC /ID# 205968

Wilmington, North Carolina, United States

University Hospitals Case Medical Center /ID# 206639

Cleveland, Ohio, United States

Awasty Research Network, LLC /ID# 206748

Marion, Ohio, United States

Southside Dermatology /ID# 214451

Tulsa, Oklahoma, United States

Vital Prospects Clinical Research Institute, PC /ID# 205824

Tulsa, Oklahoma, United States

Cyn3rgy Research /ID# 218064

Gresham, Oregon, United States

Clinical Research Institute of Southern Oregon /ID# 207544

Medford, Oregon, United States

Clinical Research Solutions, LLC /ID# 218416

Jackson, Tennessee, United States

Stones River Dermatology /ID# 205178

Murfreesboro, Tennessee, United States

Metroplex Dermatology /ID# 213307

Arlington, Texas, United States

Bellaire Dermatology /ID# 205470

Bellaire, Texas, United States

Center for Clinical Studies /ID# 213186

Cypress, Texas, United States

Dermatology Treatment and Research Center, PA /ID# 205473

Dallas, Texas, United States

Epiphany Dermatology - Fort Worth /ID# 210073

Fort Worth, Texas, United States

Styde Research, LLC /ID# 213469

Lewisville, Texas, United States

Austin Institute for Clinical Research /ID# 206640

Pflugerville, Texas, United States

Derm Clin Res Ctr San Antonio /ID# 205469

San Antonio, Texas, United States

EPIC Medical Research /ID# 206382

Murray, Utah, United States

Aspen Clinical Research /ID# 208399

Orem, Utah, United States

Timber Lane Allergy & Asthma Research, LLC /ID# 206897

South Burlington, Vermont, United States

The Education & Research Foundation, Inc. /ID# 206900

Lynchburg, Virginia, United States

Bellingham Asthma Allergy and Immunology Clinic /ID# 210357

Bellingham, Washington, United States

Clinical Investigation Specialist, Inc - Kenosha /ID# 215933

Kenosha, Wisconsin, United States

The Skin Hospital - Westmead /ID# 217846

Westmead, New South Wales, Australia

The Skin Centre /ID# 205922

Benowa, Queensland, Australia

Monash Health/Monash Children's Hospital /ID# 217917

Clayton, Victoria, Australia

Sinclair Dermatology /ID# 217791

East Melbourne, Victoria, Australia

Box Hill Hospital /ID# 206023

Melbourne, Victoria, Australia

Royal Melbourne Hospital /ID# 205919

Parkville, Victoria, Australia

Murdoch Children's Research Institute /ID# 205667

Parkville, Victoria, Australia

University Hospital St. Polten /ID# 206909

St. Pölten, Niederoesterreich, Austria

Ordensklinikum Linz GmbH, Elisabethinen /ID# 206573

Linz, Austria

Salzburger Landeskliniken (SALK) /ID# 208281

Salzburg, Austria

Sozialmedizinisches Zentrum Ost - Donauspital /ID# 206572

Vienna, Austria

Cliniques Universitaires Saint Luc /ID# 205537

Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium

UZ Gent /ID# 205181

Gent, Oost-Vlaanderen, Belgium

Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938

Liege, Belgium

Medical Center Sv. Panteleimon /ID# 210414

Sofia, Bulgaria

Acibadem City Clinic Tokuda /ID# 205292

Sofia, Bulgaria

Military Medical Academy Multiprofile Hospital /ID# 205291

Sofia, Bulgaria

Medical Center Doverie /ID# 211289

Sofia, Bulgaria

Stratica Medical /ID# 205415

Edmonton, Alberta, Canada

Alberta DermaSurgery Centre /ID# 205422

Edmonton, Alberta, Canada

Univ British Columbia /ID# 207837

Vancouver, British Columbia, Canada

Pacific Derm /ID# 206797

Vancouver, British Columbia, Canada

Skin Care Studio /ID# 205420

St. John's, Newfoundland and Labrador, Canada

SimcoMed Health Ltd /ID# 206333

Barrie, Ontario, Canada

Kingsway Clinical Research /ID# 206005

Etobicoke, Ontario, Canada

Guenther Derma Res Ctr, CA /ID# 206772

London, Ontario, Canada

DermEdge Research Inc. /ID# 206036

Mississauga, Ontario, Canada

Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138

Newmarket, Ontario, Canada

Allergy Research Canada Inc. /ID# 213547

Niagara Falls, Ontario, Canada

Sudbury Skin Clinique /ID# 206771

Sudbury, Ontario, Canada

Niakosari Medicine Professional Corporation /ID# 206004

Toronto, Ontario, Canada

Skinsense Medical Research /ID# 206873

Saskatoon, Saskatchewan, Canada

Guelph Dermatology Research /ID# 206890

Guelph, Canada

DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429

Zagreb, Grad Zagreb, Croatia

Djecja bolnica Srebrnjak /ID# 205926

Zagreb, Grad Zagreb, Croatia

Poliklinika Vlatka Cavka d.o.o. /ID# 211126

Zagreb, Grad Zagreb, Croatia

Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448

Ivanic-Grad, Zagrebacka Zupanija, Croatia

Fakultni nemocnice Plzen /ID# 205096

Plzeň 1, Plzen-jih, Czechia

Sanatorium prof. Arenbergera /ID# 205098

Prague 1, Praha 1, Czechia

Fakultni Nemocnice v Motole /ID# 218192

Prague 5, Praha 5, Czechia

Vseobecna Fakultni Nemocnice /ID# 205201

Prague, Czechia

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097

Usti nad Labem, Czechia

Aarhus University Hospital /ID# 205524

Aarhus N, Midtjylland, Denmark

Sjaellands Universitets Hospit /ID# 205960

Roskilde, Sjælland, Denmark

Hopital Prive d'Antony /ID# 206553

Antony, Ile-de-France, France

Hopital Saint-Andre /ID# 206554

Bordeaux, France

CHRU de Brest - Hopital Morvan /ID# 206555

Brest, France

C.H. de Bretagne Sud /ID# 206910

Lorient, France

Hopital Saint Louis /ID# 206552

Paris, France

Gemeinschaftspraxis /ID# 205765

Blankenfeld-mahlow, Germany

Klinikum Darmstadt GmbH /ID# 207483

Darmstadt, Germany

Universitaetsklinikum Dresden /ID# 205767

Dresden, Germany

Univ Klinik Eppendorf Hamburg /ID# 207982

Hamburg, Germany

Univ Hosp Schleswig-Holstein /ID# 206658

Kiel, Germany

Asefi, Simmern, DE /ID# 205768

Simmern, Germany

Hoffmann, Witten, DE /ID# 205766

Witten, Germany

Centroderm Wuppertal /ID# 206861

Wuppertal, Germany

251 Airforce General Hospital /ID# 205841

Athens, Attiki, Greece

Genl Hospital Andreas Syggros /ID# 204527

Athens, Attiki, Greece

Papageorgiou General Hospital Thessaloniki /ID# 204526

Nea Efkarpia, Thessaloniki, Greece

401 GSNA - 401 Army Gen Hosp /ID# 205352

Αthens, Greece

Bugat Pal Korhaz /ID# 211247

Gyöngyös, Heves, Hungary

DRC Gyogyszervizsgalo Kozpont Kft. /ID# 217855

Balatonfüred, Veszprem, Hungary

Clinexpert Kft. /ID# 211246

Budapest, Hungary

Synexus Magyarorszag Kft. /ID# 206008

Budapest, Hungary

Somogy Megyei Kaposi Mor Oktat /ID# 205611

Kaposvar, Hungary

Borsod - Abauj - Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 218072

Miskolc, Hungary

Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 205085

Pecs, Hungary

St. James's Hospital /ID# 204264

Dublin 8, Dublin, Ireland

South Infirmary Victoria Univ /ID# 204265

Cork, Ireland

Galway University Hospital /ID# 209965

Galway, Ireland

University Hospital Waterford /ID# 204266

Waterford, Ireland

Istituto Dermatologico San Gallicano /ID# 205986

Rome, Lazio, Italy

Università Cattolica Sacro Cuore /ID# 205987

Rome, Roma, Italy

A.O.U. di Brescia /ID# 205927

Brescia, Italy

Ospedale San Giovanni di Dio /ID# 205168

Cagliari, Italy

Ospedale San Salvatore - ASL 01 Avezzano - Sulmona - L'Aquila /ID# 205167

L'Aquila, Italy

AO Univ di Modena /ID# 205169

Modena, Italy

Korea University Ansan Hospital /ID# 206342

Ansan-si, Gyeonggido, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon /ID# 206391

Buncheon, Gyeonggido, Korea, Republic of

Ajou University Hospital /ID# 206341

Suwon-si, Gyeonggido, Korea, Republic of

The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529

Incheon, Korea, Republic of

Seoul National University Hospital /ID# 206396

Seoul, Korea, Republic of

Chung-Ang University Hostipal /ID# 206397

Seoul, Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital /ID# 206343

Seoul, Korea, Republic of

Bravis Ziekenhuis /ID# 206676

Bergen op Zoom, Noord-Brabant, Netherlands

Centrum Oosterwal /ID# 209640

Alkmaar, Netherlands

Reinier de Graaf /ID# 205811

Delft, Netherlands

Universitair Medisch Centrum Groningen /ID# 205162

Groningen, Netherlands

Greenlane Clinical Centre /ID# 205664

Auckland, New Zealand

CCA Braga - Hospital de Braga /ID# 205854

Braga, Portugal

Centro Hospitalar de Leiria, EPE /ID# 209906

Leiria, Portugal

Centro Hospitalar Lisboa Norte, EPE /ID# 205839

Lisboa, Portugal

Hospital CUF Descobertas /ID# 205431

Lisbon, Portugal

CHP, EPE- Hospital Geral de Sa /ID# 205187

Porto, Portugal

Centro Hospitalar de Sao Joao, EPE /ID# 205679

Porto, Portugal

National Skin Centre /ID# 205222

Singapore, Central Singapore, Singapore

National University Hospital /ID# 205224

Singapore, Singapore

Singapore General Hospital /ID# 205225

Singapore, Singapore

KK Women's & Children Hospital /ID# 206693

Singapore, Singapore

Changi General Hospital /ID# 205223

Singapore, Singapore

Hospital Vital Alvarez Buylla /ID# 205770

Mieres, Asturias, Spain

Hospital Sant Joan de Deu /ID# 218047

Esplugues de Llobregat, Barcelona, Spain

Hospital Parc de Salut del Mar /ID# 204709

Barcelona, Spain

Hospital Clinic /ID# 210564

Barcelona, Spain

Hospital Universitario Reina Sofia /ID# 204712

Cordoba, Spain

Hospital Campus de la Salud /ID# 205544

Granada, Spain

Hospital General Universitario Gregorio Maranon /ID# 204380

Madrid, Spain

Hospital Infantil Universitario Niño Jesus /ID# 210437

Madrid, Spain

Hospital Universitario Infanta Leonor /ID# 204710

Madrid, Spain

Hospital General Universitario de Valencia /ID# 210565

Valencia, Spain

National Taiwan University Hospital /ID# 204803

Taipei City, Taipei, Taiwan

Taipei Med Univ Shuang Ho Hosp /ID# 204804

New Taipei City, Taiwan

Chung Shan Medical University /ID# 205092

Taichung City, Taiwan

Linkou Chang Gung Memorial Ho /ID# 204783

Taoyuan City, Taiwan

The Royal London Hospital /ID# 206491

London, London, City Of, United Kingdom

St. Mark's Hospital /ID# 205250

Harrow, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993

Newcastle Upon Tyne, United Kingdom

Plymouth Hospitals NHS Trust /ID# 204649

Plymouth, United Kingdom

University Hospital Southampton NHS Fundation Trust /ID# 205711

Southampton, United Kingdom