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: March 31, 2022

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


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: Active, not recruiting

Phase: Phase 3

Gender: All

Age: 12 Years - 75 Years

Condition: Atopic Dermatitis

Study Type: Interventional

Lead Sponsor: AbbVie


Ages Eligible for Study: 12 Years to 75 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

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 Visit and subject meets Hanifin and Rajka criteria. - Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4. - Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit. - 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 identifier: NCT03568318

Total Skin and Beauty Derm Ctr /ID# 200548

Birmingham, Alabama, United States

Clinical Research Center AL /ID# 201865

Birmingham, Alabama, United States

ACCEL Research Sites /ID# 213364

Birmingham, Alabama, United States

Advanced Dermatology and Skin Care Centre /ID# 213550

Mobile, Alabama, United States

Arizona Research Center, Inc. /ID# 200546

Phoenix, Arizona, United States

Clear Dermatology & Aesthetics Center /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

Mosaic Dermatology /ID# 200553

Beverly Hills, California, United States

University of California Irvine /ID# 200902

Irvine, California, United States

Therapeutics Clinical Research /ID# 200593

San Diego, California, United States

Stanford University /ID# 200597

Stanford, California, United States

Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822

Aurora, Colorado, United States

Colorado Center for Dermatology, PLLC /ID# 203626

Centennial, Colorado, United States

Duplicate_Western States Clinical Research, Inc. /ID# 201702

Wheat Ridge, Colorado, United States

Dermatology Physicians of Connecticut /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 Research of West Florida, Inc /ID# 203643

Clearwater, Florida, United States

Florida Academic Centers Research and Education /ID# 200544

Coral Gables, Florida, United States

Tory P Sullivan, MD PA /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 Dermatology Clinical Trials Unit /ID# 200556

Skokie, 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 of Kansas LLC /ID# 203026

Overland Park, Kansas, United States

ORA, Inc. /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

Clin Res Inst of Michigan, LLC /ID# 208020

Chesterfield, Michigan, United States

Michigan Center for Research Company /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

Dartmouth-Hitchcock Medical Center /ID# 200918

Lebanon, New Hampshire, United States

Psoriasis Treatment Center of Central New Jersey /ID# 200714

East Windsor, New Jersey, United States

Juva Skin and Laser Center /ID# 200997

New York, New York, United States

J. Schwartz, MD, PLLC /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 Dermatology and Research Center /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 of Seattle /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

St 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

Ordensklinikum Linz GmbH Elisabethinen /ID# 209567

Linz, Oberoesterreich, Austria

Kepler Universitaetsklinikum GmbH /ID# 201075

Linz, Oberoesterreich, Austria

Medizinische Universitaet Innsbruck /ID# 210897

Innsbruck, Tirol, Austria

Medizinische Universitaet Wien /ID# 201080

Vienna, Wien, Austria

UZ Brussel /ID# 203557

Jette, Bruxelles-Capitale, Belgium

UCL Saint-Luc /ID# 202028

Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium

UZ Gent /ID# 202030

Gent, Oost-Vlaanderen, Belgium

IMTR - Grand Hopital de Charleroi /ID# 202029

Loverval, Belgium

Kirk Barber Research, CA /ID# 200329

Calgary, Alberta, Canada

Dermatology Research Institute Inc. /ID# 200341

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

Angela Montgomery Medicine Professional Corporation /ID# 212653

Ottawa, Ontario, Canada

SKIN Centre for Dermatology /ID# 200331

Peterborough, Ontario, Canada

The Center For Dermatology /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

Québec, Quebec, Canada

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

Saint-Jerome, Quebec, Canada

Chinese PLA General Hospital /ID# 206786

Beijing, Beijing, China

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

Guangzhou, Guangdong, China

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

Wuhan, Hubei, China

The First Hospital of China Medical University /ID# 209840

Shenyang, Liaoning, China

The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132

Hangzhou, Zhejiang, China

The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442

Hangzhou, Zhejiang, China

Beijing Friendship Hospital /ID# 207434

Beijing, China

Xiangya Hospital Central South University /ID# 207510

Changsha, China

Huashan Hospital of Fudan University /ID# 207437

Shanghai, China

Fakultni nemocnice Plzen /ID# 202044

Plzen, Czechia

Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248

Prague, Czechia

Sanatorium profesora Arenbergera /ID# 202082

Praha, Czechia

Vseobecna fakultni nemocnice v Praze /ID# 202045

Praha, Czechia

Chu de Nice-Hopital L'Archet Ii /Id# 205780

Nice, Alpes-Maritimes, France

AP-HM - Hopital de la Timone /ID# 206128

Marseille CEDEX 05, Bouches-du-Rhone, France

CHRU Tours - Hopital Gatien de Clocheville /ID# 218209

Tours, Centre-Val De Loire, France

Hopital Saint-Andre /ID# 206129

Bordeaux, France

Polyclinique Courlancy /ID# 201537

Reims, France

Universitaetsklinik Heidelberg /ID# 202097

Heidelberg, Baden-Wuerttemberg, Germany

Universitaetsklinikum Frankfurt /ID# 202095

Frankfurt am Main, Hessen, Germany

Universitaetsklinikum Muenster /ID# 202094

Muenster, Nordrhein-Westfalen, Germany

CMS3 Company for Medical Study /ID# 205195

Selters, Rheinland-Pfalz, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256

Kiel, Schleswig-Holstein, Germany

Universitaetsklinikum Bonn /ID# 202092

Bonn, Germany

TFS Trial Form Support GmbH /ID# 202096

Hamburg, Germany

Medizinische Hochschule Hannover /ID# 202098

Hannover, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194

Mainz, Germany

Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093

Munich, Germany

401 GSNA - 401 Army General Hospital /ID# 211963

Athens, Attiki, Greece

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

Athens, Attiki, Greece

University General Hospital Attikon /ID# 201126

Athens, Attiki, Greece

General Hospital Andreas Syggros /ID# 201123

Athens, Attiki, Greece

Papageorgiou General Hospital Thessaloniki /ID# 202392

Stavroupoli (Thessalonikis), Thessaloniki, Greece

Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124

Thessaloniki, Greece

Prince of Wales Hospital /ID# 205152

Hong Kong, Hong Kong

Queen Mary Hospital /ID# 205146

Hong Kong, Hong Kong

Oroshazi Korhaz /ID# 203525

Oroshaza, Bekes, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144

Szeged, Csongrad, Hungary

Debreceni Egyetem Klinikai Kozpont /ID# 201765

Debrecen, Hajdu-Bihar, Hungary

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

Debrecen, Hungary

Allergo-Derm Bakos Kft. /ID# 205361

Szolnok, Hungary

St James Hospital /ID# 201118

Dublin 8, Dublin, Ireland

South Infirmary Victoria University Hospital /ID# 201079

Cork, Ireland

University Hospital Waterford /ID# 201253

Waterford, Ireland

Soroka University Medical Center /ID# 206652

Be'er Sheva, HaDarom, Israel

The Chaim Sheba Medical Center /ID# 201611

Ramat Gan, Tel-Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 201608

Tel Aviv-Yafo, Tel-Aviv, Israel

HaEmek Medical Center /ID# 201958

Afula, Israel

Rabin Medical Center /ID# 201959

Petakh Tikva, Israel

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014

Rome, Lazio, Italy

Istituto Clinico Humanitas /ID# 200739

Rozzano, Milano, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690

Ancona, Italy

A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742

Catania, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744

Milan, Italy

Azienda Ospedaliera Universitaria Federico II /ID# 200751

Napoli, 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

Queens Square Medical Center dermatology allergology /ID# 203850

Yokohama-shi, Kanagawa, Japan

Kyoto University Hospital /ID# 201654

Kyoto-shi, Kyoto, 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

Erasmus Medisch Centrum /ID# 202196

Rotterdam, Zuid-Holland, Netherlands

Academisch Medisch Centrum /ID# 202193

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen /ID# 202195

Groningen, 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 - Hato Rey /ID# 202003

San Juan, Puerto Rico

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372

Banska Bystrica, Slovakia

Univerzitna nemocnica Martin /ID# 203851

Martin, Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240

Nove Zamky, Slovakia

Fakultna nemocnica s poliklinikou J.A. Reimana Presov /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

Sahlgrenska University Hospital /ID# 201274

Gothenburg, Vastra Gotalands Lan, Sweden

Sodersjukhuset /ID# 201242

Stockholm, Sweden

Karolinska University Hospital /ID# 201243

Stockholm, Sweden

Barts Health NHS Trust /ID# 201044

London, London, City Of, United Kingdom

Guy's and St Thomas' NHS Foundation Trust /ID# 201193

London, London, City Of, United Kingdom

Guy's and St Thomas' NHS Foundation Trust /ID# 204642

London, London, City Of, United Kingdom

Oxford University Hospitals NHS Foundation Trust /ID# 202052

Oxford, Oxfordshire, United Kingdom

NHS Tayside /ID# 202081

Dundee, Scotland, United Kingdom

NHS Greater Glasgow and Clyde /ID# 201374

Glasgow, Scotland, United Kingdom

Leeds Teaching Hospitals NHS Trust /ID# 201106

Leeds, United Kingdom

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