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Clinical Trial Details for A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis


AbbVie
NCT ID: NCT03607422
Last Updated: October 29, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 3
  • Gender: All
  • Age: 12 Years - 75 Years
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: AbbVie
  • Location: Not Provided

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.

Eligibility

Ages Eligible for Study

12 Years to 75 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

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 risksExclusion 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

Sponsors & Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc.

AbbVie

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

Location

Contacts

Total Skin and Beauty Derm Ctr /ID# 205129

Birmingham, Alabama 35205

United States

Medical Dermatology Specialist /ID# 205516

Phoenix, Arizona 85006-2722

United States

Arizona Research Center, Inc. /ID# 205795

Phoenix, Arizona 85053-4061

United States

Wallace Medical Group, Inc. /ID# 205701

Beverly Hills, California 90211

United States

Encino Research Center / T. Jo /ID# 207472

Encino, California 91436

United States

University of California Irvine /ID# 205136

Irvine, California 92697-1385

United States

Keck School of Medicine of USC /ID# 206971

Los Angeles, California 90033

United States

Child Hosp of Orange County,CA /ID# 205735

Orange, California 92868

United States

Palmtree Clinical Research Inc. /Id# 206184

Palm Springs, California 92262

United States

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

San Diego, California 92123-4232

United States

Southern California Derma. Inc /ID# 205734

Santa Ana, California 92701

United States

Innovative Clinical Research - Lafayette /ID# 208400

Lafayette, Colorado 80026

United States

New England Research Associates, LLC /ID# 206896

Bridgeport, Connecticut 06606-1827

United States

Ideal Clinical Research Inc. /ID# 209880

Aventura, Florida 33180

United States

Skin Care Research, LLC /ID# 207099

Boca Raton, Florida 33486-2269

United States

Midflorida Clinical Research, Inc. /ID# 213700

Brandon, Florida 33511-5335

United States

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

Clearwater, Florida 33765

United States

Revival Research /ID# 208383

Doral, Florida 33122-1902

United States

Universal Axon Clinical Resear /ID# 213703

Doral, Florida 33166

United States

Floridian Clinical Research /ID# 207433

Hialeah, Florida 33016-1842

United States

Savin Medical Group, LLC /ID# 206902

Miami Lakes, Florida 33014-2490

United States

Lakes Research, LLC /ID# 209156

Miami, Florida 33014

United States

Miami Dade Medical Research In /ID# 209413

Miami, Florida 33176

United States

Ormond Medical Arts Pharmaceutical Research Center /ID# 213459

Ormond Beach, Florida 32174-6302

United States

Precision Clinical Research /ID# 207364

Sunrise, Florida 33351-7311

United States

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

Tampa, Florida 33607

United States

ForCare Clinical Research /ID# 205120

Tampa, Florida 33613-1244

United States

Marietta Dermatology Clinical Research /ID# 210317

Marietta, Georgia 30060-1047

United States

Treasure Valley Medical Research /ID# 210298

Boise, Idaho 83706

United States

Great Lakes Clinical Trials /ID# 205830

Chicago, Illinois 60640

United States

Northshore University Health System-Evanston /ID# 205135

Evanston, Illinois 60201

United States

Ashira Dermatology /ID# 205512

Gurnee, Illinois 60031-3393

United States

Clinical Investigation Specialists, Inc. /ID# 206898

Gurnee, Illinois 60031

United States

Raga Clinical Studies, LLC. /ID# 206749

Crown Point, Indiana 46307

United States

Hutchinson Clinic /ID# 205970

Hutchinson, Kansas 67502-1131

United States

Continental Clinical Solutions /ID# 210327

Towson, Maryland 21204

United States

Beacon Clinical Research, LLC /ID# 206894

Quincy, Massachusetts 02169

United States

David Fivenson, MD, PLC /ID# 206903

Ann Arbor, Michigan 48103

United States

University of Michigan Hospitals /ID# 206895

Ann Arbor, Michigan 48109

United States

Skin Specialists, PC /ID# 205515

Omaha, Nebraska 68144

United States

Summit Medical Group /ID# 213863

Clifton, New Jersey 07012-1647

United States

Skin Laser and Surgery Specialists /ID# 206754

Hackensack, New Jersey 07601-1997

United States

University of New Mexico School of Medicine /ID# 206756

Albuquerque, New Mexico 87131-0001

United States

PMG Research of Wilmington LLC /ID# 205968

Wilmington, North Carolina 28401

United States

University Hospitals Case Medical Center /ID# 206639

Cleveland, Ohio 44106

United States

Awasty Research Network, LLC /ID# 206748

Marion, Ohio 43302-6225

United States

Southside Dermatology /ID# 214451

Tulsa, Oklahoma 74135-5618

United States

Vital Prospects Clinical Research Institution /ID# 205824

Tulsa, Oklahoma 74136-7049

United States

Clinical Research Institute of Southern Oregon /ID# 207544

Medford, Oregon 97504-9741

United States

Stones River Dermatology /ID# 205178

Murfreesboro, Tennessee 37129-3194

United States

Metroplex Dermatology /ID# 213307

Arlington, Texas 76014

United States

Bellaire Dermatology /ID# 205470

Bellaire, Texas 77401

United States

Center for Clinical Studies /ID# 213186

Cypress, Texas 77433

United States

Derm Treatment and Res Ctr /ID# 205473

Dallas, Texas 75230

United States

Epiphany Dermatology /ID# 210073

Fort Worth, Texas 76244-6548

United States

Styde Research, LLC /ID# 213469

Lewisville, Texas 75067

United States

Austin Center for Clinical Research /ID# 206640

Pflugerville, Texas 78660

United States

Derm Clin Res Ctr San Antonio /ID# 205469

San Antonio, Texas 78229

United States

EPIC Medical Research /ID# 206382

Murray, Utah 84123-5632

United States

Aspen Clinical Research /ID# 208399

Orem, Utah 84058

United States

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

South Burlington, Vermont 05403-7204

United States

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

Lynchburg, Virginia 24501-1403

United States

Bellingham Asthma Allergy and Immunology Clinic /ID# 210357

Bellingham, Washington 98225-1945

United States

Clinical Investigation Specialist, Inc - Kenosha /ID# 215933

Kenosha, Wisconsin 53144-1782

United States

The Skin Centre /ID# 205922

Benowa, Queensland 4217

Australia

Box Hill Hospital /ID# 206023

Melbourne, Victoria 3128

Australia

Royal Melbourne Hospital /ID# 205919

Parkville, Victoria 3050

Australia

Murdoch Children's Research Institute /ID# 205667

Parkville, Victoria 3052

Australia

University Hospital St. Polten /ID# 206909

St. Pölten, Niederoesterreich 3100

Austria

Ordensklinikum Linz GmbH, Elisabethinen /ID# 206573

Linz, 4020

Austria

Salzburger Landeskliniken (SALK) /ID# 208281

Salzburg, 5020

Austria

Sozialmedizinisches Zentrum Ost - Donauspital /ID# 206572

Vienna, 1220

Austria

Cliniques Universitaires Saint Luc /ID# 205537

Woluwe-Saint-Lambert, Bruxelles-Capitale 1200

Belgium

UZ Gent /ID# 205181

Gent, Oost-Vlaanderen 9000

Belgium

Centre Hospitalier Universitaire du Sart Tilman (CHU de Liège) /ID# 204938

Liège, 4000

Belgium

Medical Center "Sv. Panteleimon" /ID# 210414

Sofia, 1000

Bulgaria

Acibadem City Clinic Tokuda /ID# 205292

Sofia, 1407

Bulgaria

Military Medical Academy Multiprofile Hospital /ID# 205291

Sofia, 1606

Bulgaria

Medical Center Doverie /ID# 211289

Sofia, 1632

Bulgaria

Stratica Medical /ID# 205415

Edmonton, Alberta T5K 2V4

Canada

Alberta DermaSurgery Centre /ID# 205422

Edmonton, Alberta T6G 1C3

Canada

Univ British Columbia /ID# 207837

Vancouver, British Columbia V5Z 4E8

Canada

Pacific Derm /ID# 206797

Vancouver, British Columbia V6H 4E1

Canada

Dr. Brown-Maher PMC INC. /ID# 205420

St. John's, Newfoundland and Labrador A1E 1V4

Canada

SimcoMed Health Ltd /ID# 206333

Barrie, Ontario L4M 7G1

Canada

Kingsway Clinical Research /ID# 206005

Etobicoke, Ontario M8X 1Y9

Canada

Guenther Derma Res Ctr, CA /ID# 206772

London, Ontario N6A 3H7

Canada

DermEdge Research Inc. /ID# 206036

Mississauga, Ontario L5H 1G9

Canada

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

Newmarket, Ontario L3Y 5G8

Canada

Allergy Research Canada Inc. /ID# 213547

Niagara Falls, Ontario L2H 1H5

Canada

Sudbury Skin Clinique /ID# 206771

Sudbury, Ontario P3E 5M4

Canada

Niakosari Medicine Professional Corporation /ID# 206004

Toronto, Ontario M2M 4J5

Canada

Skinsense Medical Research /ID# 206873

Saskatoon, Saskatchewan S7K 0H6

Canada

Guelph Dermatology Research /ID# 206890

Guelph, N1L 0B7

Canada

DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429

Zagreb, Grad Zagreb 10000

Croatia

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

Zagreb, Grad Zagreb 10000

Croatia

Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448

Ivanić-Grad, Zagrebacka Zupanija 10310

Croatia

Djecja bolnica Srebrnjak /ID# 205926

Zagreb, 10000

Croatia

Fakultni nemocnice Plzen /ID# 205096

Plzeň 1, Plzen-jih 301 00

Czechia

Sanatorium prof. Arenbergera /ID# 205098

Prague 1, Praha 1 110 00

Czechia

Vseobecna Fakultni Nemocnice /ID# 205201

Prague, 128 08

Czechia

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

Usti nad Labem, 40113

Czechia

Aarhus University Hospital /ID# 205524

Aarhus N, Midtjylland 8200

Denmark

Sjaellands Universitets Hospit /ID# 205960

Roskilde, Sjælland 4000

Denmark

Hopital Prive d'Antony /ID# 206553

Antony, Ile-de-France 92160

France

Hopital Saint-Andre /ID# 206554

Bordeaux, 33075

France

CHRU de Brest - Hopital Morvan /ID# 206555

Brest, 29200

France

C.H. de Bretagne Sud /ID# 206910

Lorient, 56322

France

Hopital Saint Louis /ID# 206552

Paris, 75475

France

Klinikum Darmstadt GmbH /ID# 207483

Darmstadt, 64297

Germany

Universitaetklinikum Dresden /ID# 205767

Dresden, 01307

Germany

Univ Klinik Eppendorf Hamburg /ID# 207982

Hamburg, 20246

Germany

Univ Hosp Schleswig-Holstein /ID# 206658

Kiel, 24105

Germany

Gemeinschaftspraxis /ID# 205765

Mahlow, 15831

Germany

Asefi, Simmern, DE /ID# 205768

Simmern, 55469

Germany

Hoffmann, Witten, DE /ID# 205766

Witten, 58453

Germany

Centroderm Wuppertal /ID# 206861

Wuppertal, 42287

Germany

Papageorgiou General Hospital Thessaloniki /ID# 204526

Thessaloniki, Nea Efkarpia 54603

Greece

251 Airforce General Hospital /ID# 205841

Athens, 11525

Greece

401 GSNA - 401 Army Gen Hosp /ID# 205352

Athens, 11525

Greece

Genl Hospital Andreas Syggros /ID# 204527

Athens, 16121

Greece

Bugat Pal Korhaz /ID# 211247

Gyöngyös, Heves 3200

Hungary

Pecsi Tudomanyegyetem /ID# 205085

Pécs, Pecs 7624

Hungary

Clinexpert Kft. /ID# 211246

Budapest, 1033

Hungary

Synexus Magyarorszag Kft. /ID# 206008

Budapest, 1036

Hungary

Somogy Megyei Kaposi Mor Oktat /ID# 205611

Kaposvár, 7400

Hungary

St. James's Hospital /ID# 204264

Dublin 8, Dublin D08 E9P6

Ireland

South Infirmary Victoria Univ /ID# 204265

Cork,

Ireland

Galway University Hospital /ID# 209965

Galway, H91 YR71

Ireland

University Hospital Waterford /ID# 204266

Waterford, X91 ER8E

Ireland

Istituto Dermatologico San Gallicano /ID# 205986

Rome, Lazio 00144

Italy

Università Cattolica Sacro Cuore /ID# 205987

Rome, Roma 00168

Italy

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

Brescia, 25123

Italy

Ospedale San Giovanni di Dio /ID# 205168

Cagliari, 9124

Italy

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

L'Aquila, 67100

Italy

AO Univ di Modena /ID# 205169

Modena, 41100

Italy

Soon Chun Hyang University Hospital Bucheon /ID# 206391

Bucheon, Gyeonggido 14584

Korea, Republic of

Ajou University Hospital /ID# 206341

Suwon-si, Gyeonggido 16499

Korea, Republic of

Korea University Ansan Hosp /ID# 206342

Gyeonggi-do, 152-703

Korea, Republic of

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

Incheon, 21431

Korea, Republic of

Seoul National University Hospital /ID# 206396

Seoul, 03080

Korea, Republic of

Chung-Ang University Hostipal /ID# 206397

Seoul, 06973

Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital /ID# 206343

Seoul, 07441

Korea, Republic of

Bravis Ziekenhuis /ID# 206676

Bergen op Zoom, Noord-Brabant 4624 VT

Netherlands

Centrum Oosterwal /ID# 209640

Alkmaar, 1817 MS

Netherlands

Reinier de Graaf /ID# 205811

Delft, 2625 AD

Netherlands

Universitair Medisch Centrum Groningen /ID# 205162

Groningen, 9713 GZ

Netherlands

Greenlane Clinical Centre /ID# 205664

Auckland, 1051

New Zealand

CCA Braga - Hospital de Braga /ID# 205854

Braga, 4710-243

Portugal

Centro Hospitalar de Leiria, EPE /ID# 209906

Leiria, 2410-197

Portugal

Centro Hospitalar Lisboa Norte, EPE /ID# 205839

Lisboa, 1649-035

Portugal

Hospital CUF Descobertas /ID# 205431

Lisbon, 1998-018

Portugal

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

Porto, 4050

Portugal

Centro Hospitalar de Sao Joao, EPE /ID# 205679

Porto, 4200-319

Portugal

National Skin Centre /ID# 205222

Singapore, Central Singapore 308205

Singapore

National University Hospital /ID# 205224

Singapore, 119074

Singapore

Singapore General Hospital /ID# 205225

Singapore, 169608

Singapore

KK Women's & Children Hospital /ID# 206693

Singapore, 229899

Singapore

Changi General Hospital /ID# 205223

Singapore, 529889

Singapore

Hospital Vital Alvarez Buylla /ID# 205770

Mieres, Asturias 33611

Spain

H. Del Mar, Barcelona /ID# 204709

Barcelona, 08003

Spain

Hospital Clinic de Barcelona /ID# 210564

Barcelona, 08036

Spain

Hospital Reina Sofia de Cordob /ID# 204712

Cordoba, 14004

Spain

Hospital Campus de la Salud /ID# 205544

Granada, 18016

Spain

Hosp Infantil Univ Nino Jesus /ID# 210437

Madrid, 28009

Spain

Hosp. Gral. Univ. Gregorio Mar /ID# 204380

Madrid, 28009

Spain

Hospital Infanta Leonor /ID# 204710

Madrid, 28031

Spain

Hospital General U de Valencia /ID# 210565

Valencia, 46014

Spain

National Taiwan University Hospital /ID# 204803

Taipei City, Taipei 100

Taiwan

Chung Shan Medical University /ID# 205092

Taichung City, 40201

Taiwan

Taipei Medical University Hospital /ID# 204804

Taipei City, 11031

Taiwan

Linkou Chang Gung Memorial Ho /ID# 204783

Taoyuan City, 33305

Taiwan

The Royal London Hospital /ID# 206491

London, London, City Of E1 1BB

United Kingdom

Northwick Park Hospital /ID# 205250

Harrow, HA1 3UJ

United Kingdom

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

Newcastle Upon Tyne, NE1 4LP

United Kingdom

Plymouth Hospitals NHS Trust /ID# 204649

Plymouth, PL6 8DH

United Kingdom

Southampton General Hospital /ID# 205711

Southampton, SO16 6YD

United Kingdom