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

NCT ID: NCT03568318

Last Updated: July 31, 2020

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.

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 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 Visit Exclusion 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

Collaborators: Not provided

Investigators: AbbVie Inc.

Please refer to this study by its clinicaltrials.gov identifier: NCT03568318
Location

Total Skin and Beauty Derm Ctr /ID# 200548

Birmingham, Alabama, United States

Clinical Research Center AL /ID# 201865

Birmingham, Alabama, United States

Horizon Research Partners, LLC /ID# 213550

Mobile, Alabama, United States

Arizona Research Center, Inc. /ID# 200546

Phoenix, Arizona, United States

Investigate MD /ID# 201257

Scottsdale, Arizona, United States

University of Arizona /ID# 201059

Tucson, Arizona, United States

Bakersfield Derma & Skin Cance /ID# 200892

Bakersfield, California, United States

University of California Irvine /ID# 200902

Irvine, California, United States

Therapeutics Clinical Research /ID# 200593

San Diego, California, United States

Mosaic Dermatology /ID# 200553

Santa Monica, California, United States

Stanford University /ID# 200597

Stanford, California, United States

University of Colorado Anchutz Medical Campus /ID# 202822

Aurora, Colorado, United States

Colorado Dermatology /ID# 203626

Centennial, Colorado, United States

Western States Clinical Research, Inc. /ID# 201702

Wheat Ridge, Colorado, United States

Dermatology Physicians of CT /ID# 201004

Shelton, Connecticut, United States

Clearlyderm Dermatology /ID# 207709

Boca Raton, Florida, United States

Skin Care Research, LLC /ID# 200812

Boca Raton, Florida, United States

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

Clearwater, Florida, United States

Florida Academic Centers Research and Education /ID# 200544

Coral Gables, Florida, United States

ACCEL Research Sites /ID# 213364

DeLand, Florida, United States

Sullivan Dermatology /ID# 201174

North Miami Beach, Florida, United States

Park Avenue Dermatology, PA /ID# 201012

Orange Park, Florida, United States

Precision Clinical Research /ID# 208734

Sunrise, Florida, United States

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

Boise, Idaho, United States

Northwestern University Feinberg School of Medicine /ID# 201646

Chicago, Illinois, United States

Northshore University Health System-Evanston /ID# 200556

Evanston, Illinois, United States

DuPage Medical Group /ID# 202065

Wheaton, Illinois, United States

Deaconess Clinic Downtown /ID# 201001

Evansville, Indiana, United States

Indiana University /ID# 200515

Indianapolis, Indiana, United States

Epiphany Dermatology /ID# 203026

Overland Park, Kansas, United States

ORA Clinical Res & Development /ID# 202824

Andover, Massachusetts, United States

Tufts Medical Center /ID# 200570

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center /ID# 200545

Boston, Massachusetts, United States

Great Lakes Research Group,Inc /ID# 218994

Bay City, Michigan, United States

Clin Res Inst of Michigan, LLC /ID# 208020

Chesterfield, Michigan, United States

Clarkston Skin Research /ID# 200560

Clarkston, Michigan, United States

MediSearch Clinical Trials /ID# 201006

Saint Joseph, Missouri, United States

Skin Specialists, PC /ID# 200573

Omaha, Nebraska, United States

Darmouth-Hitchcock Medical Cen /ID# 200918

Lebanon, New Hampshire, United States

Psoriasis Treatment Ctr NJ /ID# 200714

East Windsor, New Jersey, United States

Juva Skin and Laser Center /ID# 200997

New York, New York, United States

Joseph Schwartz MD Medical Cosmetic Derm /ID# 202122

Troy, New York, United States

Bexley Dermatology Research /ID# 200899

Bexley, Ohio, United States

The Ohio State University /ID# 200542

Columbus, Ohio, United States

Vital Prospects Clinical Research Institute, PC /ID# 200901

Tulsa, Oklahoma, United States

Oregon Derm & Res. Ctr /ID# 200601

Portland, Oregon, United States

University of Pittsburgh MC /ID# 206057

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital /ID# 200566

Providence, Rhode Island, United States

AAPRI Clinical Research /ID# 221134

Warwick, Rhode Island, United States

Rivergate Dermatology & Skin Care Center /ID# 201698

Goodlettsville, Tennessee, United States

Stones River Dermatology /ID# 204962

Murfreesboro, Tennessee, United States

Arlington Research Center, Inc /ID# 200559

Arlington, Texas, United States

Center for Clinical Studies /ID# 200582

Houston, Texas, United States

Progressive Clinical Research /ID# 201582

San Antonio, Texas, United States

Center for Clinical Studies - Webster TX /ID# 203186

Webster, Texas, United States

Advanced Clinical Research - Woseth Dermatology /ID# 213745

Salt Lake City, Utah, United States

Eastern Virginia Med School /ID# 200994

Norfolk, Virginia, United States

Dermatology Associates /ID# 200717

Seattle, Washington, United States

University of Wisconsin - Madison /ID# 204933

Madison, Wisconsin, United States

St George Dermatology & Skin Cancer Centre /ID# 204788

Kogarah, New South Wales, Australia

Royal North Shore Hospital /ID# 204639

Saint Leonards, New South Wales, Australia

Westmead Hospital /ID# 205682

Westmead, New South Wales, Australia

Veracity Clinical Research /ID# 204793

Woolloongabba, Queensland, Australia

Fremantle Dermatology /ID# 205306

Fremantle, Western Australia, Australia

Kepler Universitätsklinikum /ID# 201075

Linz, Oberoesterreich, Austria

Medizinische Universitat Wien, Universitatsklinik fur Dermatologie /ID# 201080

Vienna, Wien, Austria

Medizinische Universitat Innsbruck /ID# 210897

Innsbruck, Austria

Ordensklinikum Linz GmbH, Elisabethinen /ID# 209567

Linz, Austria

UZ Brussel /ID# 203557

Jette, Bruxelles-Capitale, Belgium

Cliniques Universitaires Saint Luc /ID# 202028

Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium

UZ Gent /ID# 202030

Gent, Oost-Vlaanderen, Belgium

Grand Hopital de Charleroi /ID# 202029

Loverval, Belgium

Dermatology Research Institute Inc. /ID# 200341

Calgary, Alberta, Canada

Kirk Barber Research, CA /ID# 200329

Calgary, Alberta, Canada

Alberta DermaSurgery Centre /ID# 205674

Edmonton, Alberta, Canada

Karma Clinical Trials /ID# 200339

St. John's, Newfoundland and Labrador, Canada

Eastern Canada Cutaneous Resea /ID# 200335

Halifax, Nova Scotia, Canada

Lynderm Research Inc. /ID# 200338

Markham, Ontario, Canada

DermEdge Research Inc. /ID# 200337

Mississauga, Ontario, Canada

The Centre for Clinical Trials /ID# 205404

Oakville, Ontario, Canada

JRB Research /ID# 212653

Ottawa, Ontario, Canada

Dr. Melinda Gooderham Medicine Professional Corporation /ID# 200331

Peterborough, Ontario, Canada

Ctr for Derma & Cosmetic Surge /ID# 205409

Richmond Hill, Ontario, Canada

Toronto Research Centre /ID# 205411

Toronto, Ontario, Canada

Research Toronto /ID# 205410

Toronto, Ontario, Canada

XLR8 Medical Research /ID# 205405

Windsor, Ontario, Canada

CHU Sainte-Justine /ID# 206013

Montreal, Quebec, Canada

Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403

Quebec City, Quebec, Canada

Dre Angelique Gagne-Henley M.D. inc. /ID# 200330

St-Jerome, Quebec, Canada

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

Guangzhou, Guangdong, China

Xiangya Hospital Central South University /ID# 207510

Changsha, Hunan, China

First Hospital of China Medical University /ID# 209840

Shenyang, Liaoning, China

Huashan Hospital of Fudan University /ID# 207437

Shanghai, Shanghai, China

1st Hosp College Med Zhejian /ID# 207132

Hangzhou, Zhejiang, China

The Second Affiliated Hospital /ID# 207442

Hangzhou, Zhejiang, China

Beijing Friendship Hospital /ID# 207434

Beijing, China

Chinese PLA General Hospital /ID# 206786

Beijing, China

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

Wuhan, China

Fakultni nemocnice Plzen /ID# 202044

Plzeň 1, Plzen-jih, Czechia

Sanatorium prof. Arenbergera /ID# 202082

Prague 1, Praha 1, Czechia

Vseobecna fakultni nemoc Praze /ID# 202045

Prague 2, Czechia

Vseobecna Fakultni Nemocnice /ID# 205248

Prague, Czechia

CH Pellegrin - Hopital des Enfants /ID# 218276

Bordeaux, Gironde, France

Hopital Saint-Andre /ID# 206129

Bordeaux, France

Hopital de la Timone /ID# 206128

Marseille, France

Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 205780

Nice, France

Polyclinique Courlancy /ID# 201537

Reims, France

CHRU Hopital de Tours - Gatien de Clocheville /ID# 218209

Tours, France

Universitaetsklinik Heidelberg /ID# 202097

Heidelberg, Baden-Wuerttemberg, Germany

CMS3 Company for Medical Study /ID# 205195

Selters (Westerwald), Rheinland-Pfalz, Germany

Universitaets-Hautklinik Kiel /ID# 202256

Kiel, Schleswig-Holstein, Germany

Universitaetsklinikum Bonn /ID# 202092

Bonn, Germany

Universitaetsklinikum Frankfurt /ID# 202095

Frankfurt, Germany

TFS Trial Form Support GmbH /ID# 202096

Hamburg, Germany

Med Hochschule Hanover /ID# 202098

Hannover, Germany

Univ Johannes Gutenberg /ID# 205194

Mainz, Germany

Universitatsklinikum Munster /ID# 202094

Muenster, Germany

TU Uniklinik Munchen /ID# 202093

Munich, Germany

Children's Hosp P. A. Kyriakou /ID# 217573

Athens, Attiki, Greece

Genl Hospital Andreas Syggros /ID# 201123

Athens, Attiki, Greece

General Univ Hosp Attikon /ID# 201126

Haidari, Attiki, Greece

Papageorgiou General Hospital Thessaloniki /ID# 202392

Nea Efkarpia, Thessaloniki, Greece

Hosp Skin and Venereal Dis /ID# 201124

Thessaloniki, Greece

401 GSNA - 401 Army Gen Hosp /ID# 211963

Αthens, Greece

Queen Mary Hospital /ID# 205146

Hong Kong, Hong Kong

Prince of Wales Hospital /ID# 205152

Sha Tin, Hong Kong

Oroshazi Korhaz /ID# 203525

Oroshaza, Bekes, Hungary

Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866

Debrecen, Hungary

Debreceni Egyetem Klinikai Központ /ID# 201765

Debrecen, Hungary

Szegedi Tudomanyegyetem /ID# 204144

Szeged, Hungary

Allergo-Derm Bakos /ID# 205361

Szolnok, Hungary

St. James's Hospital /ID# 201118

Dublin 8, Dublin, Ireland

South Infirmary Victoria Univ /ID# 201079

Cork, Ireland

University Hospital Waterford /ID# 201253

Waterford, Ireland

Soroka Medical Center /ID# 206652

Be'er Sheva, HaDarom, Israel

Rabin Medical Center /ID# 201959

Petakh Tikva, Tel-Aviv, Israel

HaEmek Medical Center /ID# 201958

Afula, Israel

Sheba Medical Center /ID# 201611

Ramat Gan, Israel

Ichilov Medical Center /ID# 201608

Tel Aviv, Israel

AOU Federico II /ID# 200751

Naples, Campania, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744

Milan, Lombardia, Italy

IBD Center - IRCCS Istituto Clinico Humanitas /ID# 200739

Rozzano, Milano, Italy

Università Cattolica Sacro Cuore /ID# 203014

Rome, Roma, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690

Ancona, Italy

Universita di Catania /ID# 200742

Catania, Italy

Chukyo Hospital /ID# 202311

Nagoya-shi, Aichi, Japan

Medical Corporation Matsuo Clinic /ID# 202312

Fukuoka-shi, Fukuoka, Japan

Hiroshima University Hospital /ID# 201914

Hiroshima-shi, Hiroshima, Japan

HIRAMOTO skin clinic /ID# 204048

Amagasaki-shi, Hyogo, Japan

National Hospital Organization Sagamihara National Hospital /ID# 201658

Sagamihara-shi, Kanagawa, Japan

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

Yokohama City, Kanagawa, Japan

Tohoku University Hospital /ID# 206322

Sendai-shi, Miyagi, Japan

Osaka Habikino Medical Center /ID# 204243

Habikino-shi, Osaka, Japan

Jichi Medical University Hospital /ID# 201913

Shimotsuke-shi, Tochigi, Japan

Juntendo University Hospital /ID# 202888

Bunkyo-ku, Tokyo, Japan

Tokai University Hachioji Hospital /ID# 201711

Hachioji-shi, Tokyo, Japan

Maruyama Dermatology Clinic /ID# 202350

Koto-ku, Tokyo, Japan

Yamate Dermatological Clinic /ID# 202130

Shinjuku-ku, Tokyo, Japan

Kyoto University Hospital /ID# 201654

Sakyo-ku, Japan

Academisch Medisch Centrum /ID# 202193

Amsterdam, Noord-Holland, Netherlands

Universitair Medisch Centrum Groningen /ID# 202195

Groningen, Netherlands

Erasmus Medisch Centrum /ID# 202196

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht /ID# 202194

Utrecht, Netherlands

Clinical Trials NZ /ID# 205336

Hamilton, New Zealand

Haukeland University Hospital /ID# 201152

Bergen, Hordaland, Norway

Universitetssykehuset N-Norge, Harstad /ID# 201269

Harstad, Troms, Norway

Universitetssykehuset N-Norge, Tromso /ID# 201270

Tromso, Troms, Norway

Rikshospitalet OUS HF /ID# 201271

Oslo, Norway

Dr. Samuel Sanchez, PSC /ID# 202002

Caguas, Puerto Rico

Clinical Research Puerto Rico /ID# 203644

San Juan, Puerto Rico

GCM Medical Group, PSC /ID# 202003

San Juan, Puerto Rico

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

Banska Bystrica, Banskobystricky Kraj, Slovakia

FNsP Nove Zamky /ID# 204240

Nove Zamky, Nitriansky Kraj, Slovakia

Univerzitna nemocnica Martin /ID# 203851

Martin, Zilinsky Kraj, Slovakia

FNsP J.A. Reimana /ID# 204373

Presov, Slovakia

Hospital Universitario de Puerto Real /ID# 200875

Puerto Real, Cadiz, Spain

Hospital General Universitario Alicante /ID# 200873

Alicante, Spain

Hospital Santa Creu i Sant Pau /ID# 201325

Barcelona, Spain

Hospital Universitario de la Princesa /ID# 201517

Madrid, Spain

Hospital Universitario 12 de Octubre /ID# 201135

Madrid, Spain

Hospital Universitario La Paz /ID# 205438

Madrid, Spain

Skane University Hospital Lund /ID# 201244

Lund, Skane Lan, Sweden

Hudkliniken SU/Sahlgrenska /ID# 201274

Goteborg, Sweden

Sodersjukhuset /ID# 201242

Stockholm, Sweden

Karolinska University Hospital /ID# 201243

Stockholm, Sweden

St. Thomas Hospital /ID# 204642

London, England, United Kingdom

Royal Hospital for Children /ID# 201374

Glasgow, Glasgow City, United Kingdom

Whipps Cross Univ Hospital /ID# 201044

London, London, City Of, United Kingdom

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

London, London, City Of, United Kingdom

Ninewells Hospital /ID# 202081

Dundee, United Kingdom

Chapel Allerton Hospital /ID# 201106

Leeds, United Kingdom

Churchill Hospital /ID# 202052

Oxford, United Kingdom