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Clinical Trial Details for A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis


AbbVie
NCT ID: NCT03568318
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 Combination With Topical Corticosteroids 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 combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe Atopic dermatitis (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 Visit- Active moderate to severe atopic dermatitis 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 atopic dermatitis- Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline VisitExclusion Criteria:- Prior exposure to any Janus kinase (JAK) inhibitor- Unable or unwilling to discontinue current atopic dermatitis (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: NCT03568318

Location

Contacts

Total Skin and Beauty Derm Ctr /ID# 200548

Birmingham, Alabama 35205

United States

Clinical Research Center AL /ID# 201865

Birmingham, Alabama 35209-6802

United States

Horizon Research Partners, LLC /ID# 213550

Mobile, Alabama 36605-3004

United States

Arizona Research Center, Inc. /ID# 200546

Phoenix, Arizona 85053-4061

United States

Investigate MD /ID# 201257

Scottsdale, Arizona 85255-4134

United States

University of Arizona /ID# 201059

Tucson, Arizona 85719

United States

Bakersfield Derma & Skin Cance /ID# 200892

Bakersfield, California 93309

United States

University of California Irvine /ID# 200902

Irvine, California 92697-1385

United States

Therapeutics Clinical Research /ID# 200593

San Diego, California 92123

United States

Mosaic Dermatology /ID# 200553

Santa Monica, California 90404

United States

Stanford University /ID# 200597

Stanford, California 94305

United States

University of Colorado Anchutz Medical Campus /ID# 202822

Aurora, Colorado 80045-2517

United States

Colorado Dermatology /ID# 203626

Centennial, Colorado 80111-1724

United States

Western States Clinical Research, Inc. /ID# 201702

Wheat Ridge, Colorado 80033-2896

United States

Dermatology Physicians of CT /ID# 201004

Shelton, Connecticut 06484-6211

United States

Clearlyderm Dermatology /ID# 207709

Boca Raton, Florida 33433-3424

United States

Skin Care Research, LLC /ID# 200812

Boca Raton, Florida 33486-2269

United States

Clinical Res of West FL, Inc. /ID# 203643

Clearwater, Florida 33765

United States

Florida Academic Centers Research and Education /ID# 200544

Coral Gables, Florida 33134

United States

ACCEL Research Sites /ID# 213364

DeLand, Florida 32720

United States

Sullivan Dermatology /ID# 201174

North Miami Beach, Florida 33162-4708

United States

Park Avenue Dermatology, PA /ID# 201012

Orange Park, Florida 32073

United States

Precision Clinical Research /ID# 208734

Sunrise, Florida 33351-7311

United States

Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628

Boise, Idaho 83713

United States

Northwestern University Feinberg School of Medicine /ID# 201646

Chicago, Illinois 60611-2927

United States

Northshore University Health System-Evanston /ID# 200556

Evanston, Illinois 60201

United States

DuPage Medical Group /ID# 202065

Wheaton, Illinois 60189-3801

United States

Deaconess Clinic Downtown /ID# 201001

Evansville, Indiana 47713-1227

United States

Indiana University /ID# 200515

Indianapolis, Indiana 46202

United States

Kansas City Dermatology PA /ID# 203026

Overland Park, Kansas 66215

United States

ORA Clinical Res & Development /ID# 202824

Andover, Massachusetts 01810

United States

Tufts Medical Center /ID# 200570

Boston, Massachusetts 02111

United States

Beth Israel Deaconess Medical Center /ID# 200545

Boston, Massachusetts 02215-5400

United States

Clin Res Inst of Michigan, LLC /ID# 208020

Chesterfield, Michigan 48047

United States

Clarkston Skin Research /ID# 200560

Clarkston, Michigan 48346

United States

MediSearch Clinical Trials /ID# 201006

Saint Joseph, Missouri 64506-2459

United States

Skin Specialists, PC /ID# 200573

Omaha, Nebraska 68144

United States

Darmouth-Hitchcock Medical Cen /ID# 200918

Lebanon, New Hampshire 03756

United States

Psoriasis Treatment Ctr NJ /ID# 200714

East Windsor, New Jersey 08520

United States

Juva Skin and Laser Center /ID# 200997

New York, New York 10022-3204

United States

Joseph Schwartz MD Medical Cosmetic Derm /ID# 202122

Troy, New York 12180-2323

United States

Bexley Dermatology Research /ID# 200899

Bexley, Ohio 43209-2422

United States

The Ohio State University /ID# 200542

Columbus, Ohio 43210-1257

United States

Vital Prospects Clinical Research Institution /ID# 200901

Tulsa, Oklahoma 74136-7049

United States

Oregon Derm & Res. Ctr /ID# 200601

Portland, Oregon 97210

United States

University of Pittsburgh MC /ID# 206057

Pittsburgh, Pennsylvania 15260

United States

Rhode Island Hospital /ID# 200566

Providence, Rhode Island 02903

United States

Rivergate Dermatology & Skin Care Center /ID# 201698

Goodlettsville, Tennessee 37072-2301

United States

Stones River Dermatology /ID# 204962

Murfreesboro, Tennessee 37129-3194

United States

Arlington Research Center, Inc /ID# 200559

Arlington, Texas 76011

United States

Center for Clinical Studies /ID# 200582

Houston, Texas 77004

United States

Progressive Clinical Research /ID# 201582

San Antonio, Texas 78229

United States

Center for Clinical Studies - Webster TX /ID# 203186

Webster, Texas 77598

United States

Advanced Clinical Research - Woseth Dermatology /ID# 213745

Salt Lake City, Utah 84117-4209

United States

Eastern Virginia Med School /ID# 200994

Norfolk, Virginia 23507-1627

United States

Dermatology Associates /ID# 200717

Seattle, Washington 98101

United States

University of Wisconsin - Madison /ID# 204933

Madison, Wisconsin 53715-1218

United States

St George Dermatology & Skin Cancer Centre /ID# 204788

Kogarah, New South Wales 2217

Australia

Royal North Shore Hospital /ID# 204639

Saint Leonards, New South Wales 2065

Australia

Westmead Hospital /ID# 205682

Westmead, New South Wales 2145

Australia

Veracity Clinical Research /ID# 204793

Woolloongabba, Queensland 4102

Australia

Fremantle Dermatology /ID# 205306

Fremantle, Western Australia 6160

Australia

Kepler Universitätsklinikum /ID# 201075

Linz, Oberoesterreich 4021

Austria

Medizinische Universitat Wien, Universitatsklinik fur Dermatologie /ID# 201080

Vienna, Wien 1090

Austria

Medical University Innsbruck /ID# 210897

Innsbruck, 6020

Austria

Ordensklinikum Linz GmbH, Elisabethinen /ID# 209567

Linz, 4020

Austria

UZ Brussel /ID# 203557

Jette, Bruxelles-Capitale 1090

Belgium

Cliniques Universitaires Saint Luc /ID# 202028

Woluwe-Saint-Lambert, Bruxelles-Capitale 1200

Belgium

UZ Gent /ID# 202030

Gent, Oost-Vlaanderen 9000

Belgium

Grand Hopital de Charleroi /ID# 202029

Loverval, 6280

Belgium

Dermatology Research Institute Inc. /ID# 200341

Calgary, Alberta T1Y 0B4

Canada

Kirk Barber Research, CA /ID# 200329

Calgary, Alberta T2G 1B1

Canada

Alberta DermaSurgery Centre /ID# 205674

Edmonton, Alberta T6G 1C3

Canada

Karma Clinical Trials /ID# 200339

St. John's, Newfoundland and Labrador A1A 4Y3

Canada

Eastern Canada Cutaneous Resea /ID# 200335

Halifax, Nova Scotia B3H 1Z2

Canada

Lynderm Research Inc. /ID# 200338

Markham, Ontario L3P 1X2

Canada

DermEdge Research Inc. /ID# 200337

Mississauga, Ontario L5H 1G9

Canada

The Centre for Clinical Trials /ID# 205404

Oakville, Ontario L6J 7W5

Canada

JRB Research /ID# 212653

Ottawa, Ontario K1H 7X3

Canada

Dr. Melinda Gooderham Medicine /ID# 200331

Peterborough, Ontario K9J 5K2

Canada

Ctr for Derma & Cosmetic Surge /ID# 205409

Richmond Hill, Ontario L4B 1A5

Canada

Toronto Research Centre /ID# 205411

Toronto, Ontario M3H 5Y8

Canada

Research Toronto /ID# 205410

Toronto, Ontario M4W 2N2

Canada

XLR8 Medical Research /ID# 205405

Windsor, Ontario N8W 1E6

Canada

CHU Sainte-Justine /ID# 206013

Montreal, Quebec H3T 1C5

Canada

Ctr Derma du QC Metropolitain /ID# 205403

Quebec City, Quebec G1V 4X7

Canada

Dre. Angelique Gagne-Henley /ID# 200330

St-Jerome, Quebec J7Z 7E2

Canada

Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728

Guangzhou, Guangdong 510120

China

Xiangya Hospital Central South University /ID# 207510

Changsha, Hunan 410008

China

First Hospital of China Medical University /ID# 209840

Shenyang, Liaoning 110001

China

Huashan Hospital of Fudan University /ID# 207437

Shanghai, Shanghai 200040

China

1st Hosp College Med Zhejian /ID# 207132

Hangzhou, Zhejiang 310003

China

The Second Affiliated Hospital /ID# 207442

Hangzhou, Zhejiang 310009

China

Beijing Friendship Hospital /ID# 207434

Beijing, 100050

China

The General hospital of people's Liberation Amy(301 hospital) /ID# 206786

Beijing, 100853

China

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669

Wuhan, 430022

China

Fakultni nemocnice Plzen /ID# 202044

Plzeň 1, Plzen-jih 301 00

Czechia

Sanatorium prof. Arenbergera /ID# 202082

Prague 1, Praha 1 110 00

Czechia

Vseobecna fakultni nemoc Praze /ID# 202045

Prague 2, 128 08

Czechia

Vseobecna Fakultni Nemocnice /ID# 205248

Prague, 128 08

Czechia

Hopital Saint-Andre /ID# 206129

Bordeaux, 33075

France

Hopital de la Timone /ID# 206128

Marseille, 13385

France

Hopital de L'archet 2 /ID# 205780

Nice, 06202

France

Polyclinique Courlancy /ID# 201537

Reims, 51100

France

Universitaetsklinik Heidelberg /ID# 202097

Heidelberg, Baden-Wuerttemberg 69120

Germany

CMS3 Company for Medical Study /ID# 205195

Selters, Rheinland-Pfalz 56242

Germany

Universitaets-Hautklinik Kiel /ID# 202256

Kiel, Schleswig-Holstein 24105

Germany

Universitaetsklinikum Bonn /ID# 202092

Bonn, 53113

Germany

Universitaetsklinikum Frankfurt /ID# 202095

Frankfurt, 60590

Germany

TFS Trial Form Support GmbH /ID# 202096

Hamburg, 20354

Germany

Med Hochschule Hanover /ID# 202098

Hannover, 30625

Germany

Univ Johannes Gutenberg /ID# 205194

Mainz, 55131

Germany

Universitatsklinikum Munster /ID# 202094

Muenster, 48149

Germany

TU Uniklinik Munchen /ID# 202093

Munich, 80802

Germany

General Univ Hosp "Attikon" /ID# 201126

Athens, Attiki 12562

Greece

Papageorgiou General Hospital Thessaloniki /ID# 202392

Thessaloniki, Nea Efkarpia 54603

Greece

401 GSNA - 401 Army Gen Hosp /ID# 211963

Athens, 11525

Greece

Genl Hospital Andreas Syggros /ID# 201123

Athens, 16121

Greece

Hosp Skin and Venereal Dis /ID# 201124

Thessaloniki, 54643

Greece

Queen Mary Hospital /ID# 205146

Hong Kong, 999077

Hong Kong

Prince of Wales Hospital /ID# 205152

Sha Tin,

Hong Kong

Oroshazi Korhaz /ID# 203525

Orosháza, Bekes 5900

Hungary

Debreceni Egyetem Klinikai Központ /ID# 201765

Debrecen, 4032

Hungary

Szegedi Tudomanyegyetem /ID# 204144

Szeged, 6720

Hungary

Allergo-Derm Bakos /ID# 205361

Szolnok, 5000

Hungary

St. James's Hospital /ID# 201118

Dublin 8, Dublin D08 E9P6

Ireland

South Infirmary Victoria Univ /ID# 201079

Cork,

Ireland

University Hospital Waterford /ID# 201253

Waterford, X91 ER8E

Ireland

Soroka Medical Center /ID# 206652

Be'er Sheva, HaDarom 84101

Israel

Rabin Medical Center /ID# 201959

Petach Tikva, Tel-Aviv 4941492

Israel

HaEmek Medical Center /ID# 201958

Afula, 1834111

Israel

Sheba Medical Center /ID# 201611

Ramat Gan, 5262100

Israel

Ichilov Medical Center /ID# 201608

Tel Aviv, 64239

Israel

AOU Federico II /ID# 200751

Naples, Campania 80131

Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 200744

Milan, Lombardia 20122

Italy

Istituto Clinico Humanitas /ID# 200739

Rozzano, Milano 20089

Italy

Università Cattolica Sacro Cuore /ID# 203014

Rome, Roma 00168

Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690

Ancona, 60126

Italy

Universita di Catania /ID# 200742

Catania, 95123

Italy

Chukyo Hospital /ID# 202311

Nagoya-shi, Aichi 457-8510

Japan

Medical Corporation Matsuo Clinic /ID# 202312

Fukuoka-shi, Fukuoka 8190373

Japan

HIRAMOTO skin clinic /ID# 204048

Amagasaki-shi, Hyogo 6610953

Japan

National Hospital Organization Sagamihara National Hospital /ID# 201658

Sagamihara-shi, Kanagawa 252-0315

Japan

Queen's Square Medical Center dermatology, allergology /ID# 203850

Yokohama City, Kanagawa 2206208

Japan

Tohoku University Hospital /ID# 206322

Sendai-shi, Miyagi 980-8574

Japan

Osaka Habikino Medical Center /ID# 204243

Habikino-shi, Osaka 5838588

Japan

Kyoto University Hospital /ID# 201654

Kyoto, Sakyo-ku 606-8507

Japan

Jichi Medical University Hospital /ID# 201913

Shimotsuke-shi, Tochigi 329-0498

Japan

Juntendo University Hospital /ID# 202888

Bunkyo-ku, Tokyo 113-8431

Japan

Tokai University Hachioji Hospital /ID# 201711

Hachioji, Tokyo 192-0032

Japan

Maruyama Dermatology Clinic /ID# 202350

Koto-ku, Tokyo 1360074

Japan

Yamate Dermatological Clinic /ID# 202130

Shinjuku-ku, Tokyo 1690075

Japan

Hiroshima University Hospital /ID# 201914

Hiroshima, 734-8551

Japan

Academisch Medisch Centrum /ID# 202193

Amsterdam, 1105 AZ

Netherlands

Universitair Medisch Centrum Groningen /ID# 202195

Groningen, 9713 GZ

Netherlands

Erasmus Medisch Centrum /ID# 202196

Rotterdam, 3015 CE

Netherlands

Universitair Medisch Centrum Utrecht /ID# 202194

Utrecht, 3584 CX

Netherlands

Clinical Trials NZ /ID# 205336

Hamilton, 3206

New Zealand

Haukeland University Hospital /ID# 201152

Bergen, Hordaland 5021

Norway

Universitetssykehuset N-Norge, Harstad /ID# 201269

Harstad, Troms 9406

Norway

Universitetssykehuset N-Norge, Tromsø /ID# 201270

Tromsø, Troms 9019

Norway

Rikshospitalet OUS HF /ID# 201271

Oslo, 0450

Norway

Dr. Samuel Sanchez, PSC /ID# 202002

Caguas, 00727

Puerto Rico

GCM Medical Group /ID# 202003

San Juan, 00909

Puerto Rico

Clinical Research Puerto Rico /ID# 203644

San Juan, 0090

Puerto Rico

FNsP F.D.Roosevelta Banska Bys /ID# 204372

Banska Bystrica, Banskobystricky Kraj 975 17

Slovakia

FNsP Nove Zamky /ID# 204240

Nové Zámky, Nitriansky Kraj 940 02

Slovakia

Univerzitna nemocnica Martin /ID# 203851

Martin, Zilinsky Kraj 036 01

Slovakia

FNsP J.A. Reimana /ID# 204373

Presov, 081 01

Slovakia

Hospital General Univ Alicante /ID# 200873

Alicante, 03550

Spain

Hospital Santa Creu i Sant Pau /ID# 201325

Barcelona, 08026

Spain

Hospital Univ de la Princesa /ID# 201517

Madrid, 28006

Spain

Hosp Univ 12 de Octubre /ID# 201135

Madrid, 28041

Spain

Hospital Universitario La Paz /ID# 205438

Madrid, 28046

Spain

Hospital Univ de Puerto Real /ID# 200875

Puerto Real, 11510

Spain

Skane University Hospital Lund /ID# 201244

Lund, Skane Lan SE 221 41

Sweden

Hudkliniken SU/Sahlgrenska /ID# 201274

Goteborg, 41345

Sweden

Sodersjukhuset /ID# 201242

Stockholm, 11883

Sweden

Karolinska University Hospital /ID# 201243

Stockholm, SE-17176

Sweden

St. Thomas Hospital /ID# 204642

London, England SE1 7EH

United Kingdom

Whipps Cross Univ Hospital /ID# 201044

London, London, City Of E11 1NR

United Kingdom

Guy's and St Thomas' NHS Found /ID# 201193

London, London, City Of SE1 9RT

United Kingdom

Ninewells Hospital /ID# 202081

Dundee, DD1 9SY

United Kingdom

Chapel Allerton Hospital /ID# 201106

Leeds, LS7 4SA

United Kingdom

Churchill Hospital /ID# 202052

Oxford, OX3 7LE

United Kingdom