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Clinical Trial Details for A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis


AbbVie
NCT ID: NCT03738397
Last Updated: October 22, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 3
  • Gender: All
  • Age: 18 Years - 75 Years
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: AbbVie
  • Location: Not Provided

Official Title

A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis

Purpose

This is a phase 3, randomized, multi-center study that will evaluate upadacitinib versus dupilumab in adults (18-75 years of age) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. The study is comprised of a 35-day screening period, a 24-week blinded treatment period, and a 12-week follow-up period.

Eligibility

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

– Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema
Area and Severity Index (EASI), Investigator’s Global Assessment (IGA), Body Surface
Area (BSA) and pruritus.

– Participant is a candidate for systemic therapy or have recently required systemic
therapy for AD.

Exclusion Criteria:

– Participant has prior exposure to Janus Kinase (JAK) inhibitor.

– Participant has prior exposure to dupilumab.

– Participant is unable or unwilling to discontinue current AD treatments prior to the
study.

– Participant has requirement of prohibited medications during the study.

– Participant has other active skin diseases or skin infections requiring systemic
treatment or would interfere with appropriate assessment of AD lesions.

– Female participant 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: NCT03738397

Location

Contacts

Clinical Research Center AL /ID# 210277

Birmingham, Alabama 35209-6802

United States

University of Arkansas for Medical Sciences /ID# 211688

Little Rock, Arkansas 72205

United States

Wallace Medical Group, Inc. /ID# 208524

Beverly Hills, California 90211

United States

Tien Q Nguyen MD, Inc /ID# 208934

Fountain Valley, California 92708-3701

United States

UCSF Fresno Center for Medical Education and Research /ID# 213253

Fresno, California 93701-2302

United States

Jonathan Corren, MD. INC /ID# 208987

Los Angeles, California 90025-4749

United States

California Allergy and Asthma Medical Group /ID# 213680

Los Angeles, California 90025-7014

United States

Dermatology Res. Assoc., CA /ID# 209097

Los Angeles, California 90045

United States

Dermatology Clinical Trials /ID# 214622

Newport Beach, California 92660-7853

United States

UC Davis, Dermatology /ID# 209285

Sacramento, California 95816

United States

Ucsd /Id# 208990

San Diego, California 92103

United States

Clinical Science Institute /ID# 211022

Santa Monica, California 90404-2102

United States

The Community Research of South Florida /ID# 211145

Hialeah, Florida 33016-1897

United States

Miami Dermatology and Laser Institute /ID# 212938

Miami, Florida 33173-3570

United States

Florida International Rsrch cr /ID# 211562

Miami, Florida 33173

United States

Progressive Medical Research /ID# 211994

Port Orange, Florida 32127

United States

Clinical Research Trials of Florida, Inc. /ID# 210751

Tampa, Florida 33607

United States

Integrated Clinical Research LLC /ID# 208831

West Palm Beach, Florida 33406-6063

United States

Georgia Pollens Clinical Research Centers, Inc /ID# 211092

Albany, Georgia 31707-1282

United States

Meridian Clinical Research Dermatology /ID# 213251

Savannah, Georgia 31406-2632

United States

Northwestern University Feinberg School of Medicine /ID# 208680

Chicago, Illinois 60611-2927

United States

Medical Dermatology Associates of Chicago /ID# 210265

Chicago, Illinois 60654-6903

United States

Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058

Normal, Illinois 61761

United States

Dawes Fretzin, LLC /ID# 209187

Indianapolis, Indiana 46256

United States

Beth Israel Deaconess Medical Center /ID# 209093

Boston, Massachusetts 02215-5400

United States

Beacon Clinical Research, LLC /ID# 209280

Quincy, Massachusetts 02169

United States

Clarkston Skin Research /ID# 208739

Clarkston, Michigan 48346

United States

Henry Ford Health System /ID# 208741

Detroit, Michigan 48202

United States

Clinical Research Institute, Inc /ID# 210852

Minneapolis, Minnesota 55402-2606

United States

Allergy, Asthma & Immunology Associates, PC /ID# 213481

Lincoln, Nebraska 68505-2343

United States

Skin Specialists, PC /ID# 208843

Omaha, Nebraska 68144

United States

Dartmouth-Hitchcock Med Ctr /ID# 213727

Lebanon, New Hampshire 03756

United States

Montefiore Medical Center - Moses Campus /ID# 209647

Bronx, New York 10467-2401

United States

Forest Hills Dermatology Group /ID# 209249

Forest Hills, New York 11375

United States

Wake Forest Univ HS /ID# 208892

Winston-Salem, North Carolina 27157

United States

Univ Hosp Cleveland /ID# 208852

Cleveland, Ohio 44106

United States

The Ohio State University /ID# 209254

Columbus, Ohio 43210-1257

United States

Southside Dermatology /ID# 212004

Tulsa, Oklahoma 74135-5618

United States

Oregon Medical Res Center PC /ID# 208807

Portland, Oregon 97223

United States

Oregon Health and Science University /ID# 208809

Portland, Oregon 97239

United States

Medical University of South Carolina /ID# 211054

Charleston, South Carolina 29425

United States

Clinical Research Solutions, LLC /ID# 212542

Jackson, Tennessee 38305-2163

United States

Orion Clinical Research /ID# 208765

Austin, Texas 78759-4100

United States

DiscoveResearch, Inc. /ID# 213171

Bryan, Texas 77802

United States

Epiphany Dermatology /ID# 211187

Fort Worth, Texas 76244-6548

United States

Sante Clinical Research /ID# 212970

Kerrville, Texas 78028-9640

United States

Stephen Miller, MD PA /ID# 210071

San Antonio, Texas 78249

United States

Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153

Sugar Land, Texas 77479-3153

United States

University of Utah /ID# 209001

Salt Lake City, Utah 84112-5500

United States

Clinical Research Partners, LLC /ID# 212262

Richmond, Virginia 23220-4459

United States

Premier Clinical Research /ID# 212142

Spokane, Washington 99202

United States

West Virginia Research Inst /ID# 212730

South Charleston, West Virginia 25309

United States

The Skin Hospital /ID# 214401

Darlinghurst, New South Wales 2010

Australia

Holdsworth House Medical Practice /ID# 214565

Sydney, New South Wales 2010

Australia

Veracity Clinical Research /ID# 211134

Woolloongabba, Queensland 4102

Australia

Sinclair Dermatology /ID# 209395

East Melbourne, Victoria 3002

Australia

Burswood Dermatology /ID# 214875

Victoria Park, Western Australia 6100

Australia

Dermatology Research Institute Inc. /ID# 210942

Calgary, Alberta T1Y 0B4

Canada

Kirk Barber Research, CA /ID# 209504

Calgary, Alberta T2G 1B1

Canada

Dr. Chih-ho Hong Medical Inc. /ID# 211032

Surrey, British Columbia V3R 6A7

Canada

Enverus Medical Research /ID# 209503

Surrey, British Columbia V3V 0C6

Canada

Dr. Wei Jing Loo Medicine Prof /ID# 211400

London, Ontario N6H 5L5

Canada

Lynderm Research Inc. /ID# 209505

Markham, Ontario L3P 1X2

Canada

DermEdge Research Inc. /ID# 211122

Mississauga, Ontario L5H 1G9

Canada

Allergy Research Canada Inc. /ID# 216436

Niagara Falls, Ontario L2H 1H5

Canada

Niakosari Medicine Professional Corporation /ID# 211401

Toronto, Ontario M2M 4J5

Canada

K. Papp Clinical Research /ID# 209509

Waterloo, Ontario N2J 1C4

Canada

Dre. Angelique Gagne-Henley /ID# 209498

St-Jerome, Quebec J7Z 7E2

Canada

DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 209935

Zagreb, Grad Zagreb 10000

Croatia

Klinicki bolnicki centar Zagreb /ID# 209976

Zagreb, Grad Zagreb 10000

Croatia

Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 209937

Ivanić-Grad, Zagrebacka Zupanija 10310

Croatia

Djecja bolnica Srebrnjak /ID# 209939

Zagreb, 10000

Croatia

Fakultni nemocnice Ostrava /ID# 209117

Ostrava, Praha 5 708 52

Czechia

Fakultni Nemocnice v Motole /ID# 209209

Prague 5, Praha 5 150 06

Czechia

Fakultni Nemocnice Brno /ID# 212968

Brno, 625 00

Czechia

FN Hradec Kralove /ID# 209116

Hradec Kralove, 500 05

Czechia

Nemocnice Jihlava /ID# 209131

Jihlava, 586 33

Czechia

Keski-pohjanmaa Central Hospital /ID# 209534

Kokkola, Keski-Pohjanmaa 67200

Finland

Oulu University Hospital /ID# 208961

Oulu, Pohjois-Pohjanmaa 90220

Finland

Mikkeli Central Hospital /ID# 210125

Mikkeli, 50100

Finland

Pihlajalinna Turku /ID# 209599

Turku, 20100

Finland

CHRU Lille - Hôpital Claude Huriez /ID# 209317

Lille CEDEX, Hauts-de-France 59045

France

CHU Hotel Dieu /ID# 208974

Nantes CEDEX 1, Pays-de-la-Loire 44093

France

Charles Nicolle CHU Rouen /ID# 208973

Rouen CEDEX, Seine-Maritime 76031

France

Hopital de la Timone /ID# 211245

Marseille, 13385

France

Hopital de L'archet 2 /ID# 213374

Nice, 06202

France

Polyclinique Courlancy /ID# 208975

Reims, 51100

France

Hopital Larrey - CHU de Toulouse /ID# 208976

Toulouse, 31059

France

Universitatsklinikum Munster /ID# 210935

Munster, Niedersachsen 48149

Germany

Gemeinschaftspraxis /ID# 211174

Blankenfeld-mahlow, 15831

Germany

Hautklinik Klinikum Darmstadt /ID# 210938

Darmstadt, 64297

Germany

Universitaetsklinikum Frankfurt /ID# 210934

Frankfurt, 60590

Germany

Med Hochschule Hanover /ID# 210939

Hannover, 30625

Germany

TU Uniklinik Munchen /ID# 210937

Munich, 80802

Germany

Oroshazi Korhaz /ID# 210150

Orosháza, Bekes 5900

Hungary

Pecsi Tudomanyegyetem /ID# 210892

Pécs, Pecs 7624

Hungary

Uno Medical Trials Kft /ID# 211177

Budapest XIII, 1135

Hungary

Debreceni Egyetem Klinikai Központ /ID# 210893

Debrecen, 4032

Hungary

Somogy Megyei Kaposi Mor Oktat /ID# 210149

Kaposvár, 7400

Hungary

St Vincent's University Hosp /ID# 208441

Dublin, D04 T6F4

Ireland

University Hospital Waterford /ID# 208442

Waterford, X91 ER8E

Ireland

Rabin Medical Center /ID# 210012

Petakh Tikva, Tel-Aviv 4941492

Israel

HaEmek Medical Center /ID# 210153

Afula, 1834111

Israel

Sheba Medical Center /ID# 210013

Ramat Gan, 5262100

Israel

Ichilov Medical Center /ID# 210014

Tel Aviv, 64239

Israel

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 210632

Milan, Lombardia 20122

Italy

A.O. Policlinico Sant'Orsola Malpighi /ID# 209111

Bologna, 40138

Italy

A.O.U. di Brescia /ID# 209115

Brescia, 25123

Italy

Ospedale San Giovanni di Dio /ID# 209109

Cagliari, 9124

Italy

AO Univ di Modena /ID# 209110

Modena, 41100

Italy

Policlinico Univ Tor Vergata /ID# 209112

Rome, 00133

Italy

Hospital Sultan Ismail /ID# 211037

Johor Bahru, Johor 81100

Malaysia

Hospital Pakar Sultanah Fatimah /ID# 210185

Muar, Johor 84000

Malaysia

UKM Medical Centre /ID# 209178

Kuala Lumpur, Selangor 56000

Malaysia

University Malaya Med Ctr /ID# 208861

Kuala Lumpur, 59100

Malaysia

Hospital Pulau Pinang /ID# 210212

Penang, 10450

Malaysia

Hospital Putrajaya /ID# 209177

Putrajaya, 62250

Malaysia

Bravis Ziekenhuis /ID# 208584

Bergen op Zoom, Noord-Brabant 4624 VT

Netherlands

Centrum Oosterwal /ID# 209641

Alkmaar, 1817 MS

Netherlands

Academisch Medisch Centrum /ID# 208578

Amsterdam, 1105 AZ

Netherlands

Universitair Medisch Centrum Groningen /ID# 208583

Groningen, 9713 GZ

Netherlands

Erasmus Medisch Centrum /ID# 208582

Rotterdam, 3015 CE

Netherlands

Universitair Medisch Centrum Utrecht /ID# 208579

Utrecht, 3584 CX

Netherlands

Optimal Clinical Trials Ltd /ID# 209475

Auckland, 1010

New Zealand

Clinical Trials NZ /ID# 215590

Hamilton, 3206

New Zealand

Wellington Hospital (Capital and Coast District Health Board) /ID# 215001

Wellington, 6021

New Zealand

St. Olavs Hospital HF /ID# 209137

Trondheim, Sor-Trondelag 7006

Norway

Universitetssykehuset N-Norge, Harstad /ID# 209105

Harstad, Troms 9406

Norway

Universitetssykehuset N-Norge, Tromsø /ID# 209103

Tromsø, Troms 9019

Norway

Pratia MCM Krakow /ID# 207444

Krakow, Malopolskie 30-510

Poland

Klinika Ambroziak Sp. z o.o. /ID# 207443

Warsaw, Mazowieckie 02-758

Poland

ClinicMed Daniluk, Nowak Sp.j. /ID# 211112

Białystok, Podlaskie 15-879

Poland

Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy /ID# 211103

Bydgoszcz, 85-094

Poland

Dermoklinika Medical Center /ID# 211026

Lodz, 90-436

Poland

Royalderm Agnieszka Nawrocka /ID# 211015

Warsaw, 02-962

Poland

National Skin Centre /ID# 208775

Singapore, Central Singapore 308205

Singapore

National University Hospital /ID# 208774

Singapore, 119074

Singapore

Singapore General Hospital /ID# 208776

Singapore, 169608

Singapore

KK Women's & Children Hospital /ID# 208777

Singapore, 229899

Singapore

Hospital Bellvitge /ID# 207063

Barcelona, 08907

Spain

Hospital Univ Dr. Negrin /ID# 208969

Las Palmas de Gran Canaria, 35010

Spain

Hospital de Manises /ID# 207062

Manises, 46940

Spain

Complejo Hosp Pontevedra /ID# 207139

Pontevedra, 36071

Spain

Hospital Univ Arnau Vilanova /ID# 207065

Valencia, 46015

Spain

Hosp Univ Politecnico la Fe /ID# 207064

Valencia, 46026

Spain

Skanes Universitetssjukhus /ID# 206783

Malmö, Skane Lan 214 28

Sweden

Karolinska University Hospital /ID# 207909

Stockholm, SE-17176

Sweden

China Medical University Hosp /ID# 209770

Taichung City, Taichung 40447

Taiwan

National Taiwan University Hospital /ID# 208309

Taipei City, Taipei 100

Taiwan

Chung Shan Medical University /ID# 208311

Taichung City, 40201

Taiwan

Taipei Municipal Wan Fang Hospital /ID# 209987

Taipei, 116

Taiwan

CI Zaporizhzhya Regional Skin and Venereal Clinical Dispensary /ID# 210435

Zaporizhzhya, Zaporizka Oblast 69063

Ukraine

Medical Center of private enterprise Dzerkalo /ID# 210353

Dnipro, 49000

Ukraine

Kyiv City Clinical Skin and Venereal Hospital /ID# 210755

Kyiv, 04209

Ukraine

ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210434

Rivne, 33028

Ukraine

Royal Alex Childrens County Hospital /ID# 209709

Brighton, Brighton And Hove BN2 5BE

United Kingdom

Victoria Hospital /ID# 209853

Kirkcaldy, Fife KY2 5AH

United Kingdom

Royal Hospital for Children /ID# 210451

Glasgow, Glasgow City G51 4TF

United Kingdom

The Royal Free Hospital /ID# 208659

London, London, City Of NW3 2QG

United Kingdom

Guy's and St Thomas' NHS Found /ID# 208881

London, London, City Of SE1 9RT

United Kingdom

Cardiff & Vale University Health Board /ID# 209745

Cardiff, Wales CF14 4XN

United Kingdom