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

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

August 9, 2018

Primary Completion Date

February 16, 2021

Study Completion Date

October 23, 2030

Conditions
Atopic Dermatitis
Interventions
DRUG

Placebo

Tablets taken orally once a day

DRUG

Upadacitinib

Tablets taken orally once a day

DRUG

Topical corticosteroids (TCS)

"Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.~Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid."

Trial Locations (193)

1090

Medizinische Universitaet Wien /ID# 201080, Vienna

UZ Brussel /ID# 203557, Jette

1200

UCL Saint-Luc /ID# 202028, Woluwe-Saint-Lambert

2065

Royal North Shore Hospital /ID# 204639, St Leonards

2145

Westmead Hospital /ID# 205682, Westmead

2217

St George Dermatology & Skin Cancer Centre /ID# 204788, Kogarah

3204

Clinical Trials NZ /ID# 205336, Hamilton

4010

Ordensklinikum Linz GmbH Elisabethinen /ID# 209567, Linz

4021

Kepler Universitaetsklinikum GmbH /ID# 201075, Linz

4031

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

4032

Debreceni Egyetem Klinikai Kozpont /ID# 201765, Debrecen

4102

Veracity Clinical Research /ID# 204793, Woolloongabba

5000

Allergo-Derm Bakos Kft. /ID# 205361, Szolnok

5021

Haukeland University Hospital /ID# 201152, Bergen

5900

Oroshazi Korhaz /ID# 203525, Orosháza

6020

Medizinische Universitaet Innsbruck /ID# 210897, Innsbruck

6160

Fremantle Dermatology /ID# 205306, Fremantle

6280

IMTR - Grand Hopital de Charleroi /ID# 202029, Loverval

6725

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

9000

UZ Gent /ID# 202030, Ghent

9019

Universitetssykehuset N-Norge, Tromso /ID# 201270, Tromsø

9406

Universitetssykehuset N-Norge, Harstad /ID# 201269, Harstad

11510

Hospital Universitario de Puerto Real /ID# 200875, Puerto Real

11525

401 GSNA - 401 Army General Hospital /ID# 211963, Athens

11527

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

12462

University General Hospital Attikon /ID# 201126, Athens

13385

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

15260

University of Pittsburgh MC /ID# 206057, Pittsburgh

16121

General Hospital Andreas Syggros /ID# 201123, Athens

20089

Istituto Clinico Humanitas /ID# 200739, Rozzano

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744, Milan

20537

TFS Trial Form Support GmbH /ID# 202096, Hamburg

24105

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256, Kiel

28006

Hospital Universitario de la Princesa /ID# 201517, Madrid

28041

Hospital Universitario 12 de Octubre /ID# 201135, Madrid

28046

Hospital Universitario La Paz /ID# 205438, Madrid

30625

Medizinische Hochschule Hannover /ID# 202098, Hanover

32073

Park Avenue Dermatology, PA /ID# 201012, Orange Park

33075

Hopital Saint-Andre /ID# 206129, Bordeaux

33134

Florida Academic Centers Research and Education /ID# 200544, Coral Gables

33428

Clearlyderm Dermatology /ID# 207709, Boca Raton

33765

Clinical Research of West Florida, Inc /ID# 203643, Clearwater

35205

Total Skin and Beauty Derm Ctr /ID# 200548, Birmingham

35218

ACCEL Research Sites /ID# 213364, Birmingham

37044

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

46202

Indiana University /ID# 200515, Indianapolis

48047

Clin Res Inst of Michigan, LLC /ID# 208020, Chesterfield

48149

Universitaetsklinikum Muenster /ID# 202094, Münster

48346

Michigan Center for Research Company /ID# 200560, Clarkston

51100

Polyclinique Courlancy /ID# 201537, Reims

53127

Universitaetsklinikum Bonn /ID# 202092, Bonn

54643

Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124, Thessaloniki

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194, Mainz

55536

Papageorgiou General Hospital Thessaloniki /ID# 202392, Stavroupoli (Thessalonikis)

56242

CMS3 Company for Medical Study /ID# 205195, Selters

60077

Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556, Skokie

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690, Ancona

60590

Universitaetsklinikum Frankfurt /ID# 202095, Frankfurt am Main

64506

MediSearch Clinical Trials /ID# 201006, Saint Joseph

66210

Epiphany Dermatology of Kansas LLC /ID# 203026, Overland Park

68144

Skin Specialists, PC /ID# 200573, Omaha

69120

Universitaetsklinik Heidelberg /ID# 202097, Heidelberg

76011

Arlington Research Center, Inc /ID# 200559, Arlington

77004

Center for Clinical Studies /ID# 200582, Houston

77598

Center for Clinical Studies - Webster TX /ID# 203186, Webster

78229

Progressive Clinical Research /ID# 201582, San Antonio

80131

Azienda Ospedaliera Universitaria Federico II /ID# 200751, Napoli

81675

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

83713

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

85032

Alliance Dermatology and MOHs Center, PC /ID#200540, Phoenix

85719

University of Arizona /ID# 201059, Tucson

90211

Mosaic Dermatology /ID# 200553, Beverly Hills

92123

Therapeutics Clinical Research /ID# 200593, San Diego

93309

Bakersfield Derma & Skin Cance /ID# 200892, Bakersfield

94305

Stanford University /ID# 200597, Stanford

95123

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

97210

Oregon Dermatology and Research Center /ID# 200601, Portland

98101

Dermatology Associates of Seattle /ID# 200717, Seattle

100032

Beijing Friendship Hospital /ID# 207434, Beijing

100853

Chinese PLA General Hospital /ID# 206786, Beijing

110001

The First Hospital of China Medical University /ID# 209840, Shenyang

200040

Huashan Hospital of Fudan University /ID# 207437, Shanghai

310006

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

310009

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

410008

Xiangya Hospital Central South University /ID# 207510, Changsha

430022

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

510120

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

999077

Prince of Wales Hospital /ID# 205152, Hong Kong

Queen Mary Hospital /ID# 205146, Hong Kong

1690075

Yamate Dermatological Clinic /ID# 202130, Shinjuku-ku

1834111

HaEmek Medical Center /ID# 201958, Afula

4941492

Rabin Medical Center /ID# 201959, Petah Tikva

5265601

The Chaim Sheba Medical Center /ID# 201611, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center /ID# 201608, Tel Aviv

8443901

Soroka University Medical Center /ID# 206652, Beersheba

9808574

Tohoku University Hospital /ID# 206322, Sendai

35209-6802

Clinical Research Center AL /ID# 201865, Birmingham

36605-3004

Advanced Dermatology and Skin Care Centre /ID# 213550, Mobile

85053-4061

Arizona Research Center, Inc. /ID# 200546, Phoenix

85255-4134

Clear Dermatology & Aesthetics Center /ID# 201257, Scottsdale

92697-1385

University of California Irvine /ID# 200902, Irvine

80045-2517

Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822, Aurora

80111-1724

Colorado Center for Dermatology, PLLC /ID# 203626, Centennial

80033-2896

Duplicate_Western States Clinical Research, Inc. /ID# 201702, Wheat Ridge

06484-6211

Dermatology Physicians of Connecticut /ID# 201004, Shelton

33486-2269

Skin Care Research, LLC /ID# 200812, Boca Raton

33162-4708

Tory P Sullivan, MD PA /ID# 201174, North Miami Beach

33351-7311

Precision Clinical Research /ID# 208734, Sunrise

60611-2927

Northwestern University Feinberg School of Medicine /ID# 201646, Chicago

60189-3801

DuPage Medical Group /ID# 202065, Wheaton

47713-1227

Deaconess Clinic Downtown /ID# 201001, Evansville

01810

ORA, Inc. /ID# 202824, Andover

02111-1552

Tufts Medical Center /ID# 200570, Boston

02215-5400

Beth Israel Deaconess Medical Center /ID# 200545, Boston

03756

Dartmouth-Hitchcock Medical Center /ID# 200918, Lebanon

08520

Psoriasis Treatment Center of Central New Jersey /ID# 200714, East Windsor

10022-3204

Juva Skin and Laser Center /ID# 200997, New York

12180-2323

J. Schwartz, MD, PLLC /ID# 202122, Troy

43209-2422

Bexley Dermatology Research /ID# 200899, Bexley

43210-1257

The Ohio State University /ID# 200542, Columbus

74136-7049

Vital Prospects Clinical Research Institute, PC /ID# 200901, Tulsa

02903

Rhode Island Hospital /ID# 200566, Providence

02886-2876

AAPRI Clinical Research /ID# 221134, Warwick

37072-2301

Rivergate Dermatology & Skin Care Center /ID# 201698, Goodlettsville

37129-3194

Stones River Dermatology /ID# 204962, Murfreesboro

84117-4209

Advanced Clinical Research - Woseth Dermatology /ID# 213745, Salt Lake City

23507-1627

Eastern Virginia Med School /ID# 200994, Norfolk

53715-1218

University of Wisconsin - Madison /ID# 204933, Madison

T2G 1B1

Kirk Barber Research, CA /ID# 200329, Calgary

T2J 7E1

Dermatology Research Institute Inc. /ID# 200341, Calgary

T6G 1C3

Alberta DermaSurgery Centre /ID# 205674, Edmonton

A1A 4Y3

Karma Clinical Trials /ID# 200339, St. John's

B3H 1Z2

Eastern Canada Cutaneous Resea /ID# 200335, Halifax

L3P 1X2

Lynderm Research Inc. /ID# 200338, Markham

L5H 1G9

DermEdge Research Inc. /ID# 200337, Mississauga

L6J 7W5

The Centre for Clinical Trials /ID# 205404, Oakville

K1H 7X3

Angela Montgomery Medicine Professional Corporation /ID# 212653, Ottawa

K9J 5K2

SKIN Centre for Dermatology /ID# 200331, Peterborough

L4B 1A5

The Center For Dermatology /ID# 205409, Richmond Hill

M3H 5Y8

Toronto Research Centre /ID# 205411, Toronto

M4W 2N4

Research Toronto /ID# 205410, Toronto

N8W 1E6

XLR8 Medical Research /ID# 205405, Windsor

H3T 1C5

CHU Sainte-Justine /ID# 206013, Montreal

G1V 4X7

Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403, Québec

J7Z 7E2

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

305 99

Fakultni nemocnice Plzen /ID# 202044, Pilsen

110 00

Sanatorium profesora Arenbergera /ID# 202082, Prague

128 08

Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248, Prague

Vseobecna fakultni nemocnice v Praze /ID# 202045, Prague

06200

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

D08 NHY1

St James Hospital /ID# 201118, Dublin

T12 X23H

South Infirmary Victoria University Hospital /ID# 201079, Cork

X91 ER8E

University Hospital Waterford /ID# 201253, Waterford

00168

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

457-8510

Chukyo Hospital /ID# 202311, Nagoya

819-0373

Medical Corporation Matsuo Clinic /ID# 202312, Fukuoka

734-8551

Hiroshima University Hospital /ID# 201914, Hiroshima

060-0063

Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665, Sapporo

661-0953

Hiramoto skin clinic /ID# 204048, Amagasaki-shi

252-0392

National Hospital Organization Sagamihara National Hospital /ID# 201658, Sagamihara-shi

220-6208

Queens Square Medical Center dermatology allergology /ID# 203850, Yokohama

602-8566

University Hospital Kyoto Prefectural University of Medicine /ID#258604, Kyoto

606-8507

Kyoto University Hospital /ID# 201654, Kyoto

583-8588

Osaka Habikino Medical Center /ID# 204243, Habikino-shi

329-0498

Jichi Medical University Hospital /ID# 201913, Shimotsuke-shi

113-8431

Juntendo University Hospital /ID# 202888, Bunkyo-ku

192-0032

Tokai University Hachioji Hospital /ID# 201711, Hachioji-shi

136-0074

Maruyama Dermatology Clinic /ID# 202350, Koto-ku

3015 GD

Erasmus Medisch Centrum /ID# 202196, Rotterdam

1105 AZ

Academisch Medisch Centrum /ID# 202193, Amsterdam

9713 GZ

Universitair Medisch Centrum Groningen /ID# 202195, Groningen

3584 CX

Universitair Medisch Centrum Utrecht /ID# 202194, Utrecht

0450

Rikshospitalet OUS HF /ID# 201271, Oslo

00727

Dr. Samuel Sanchez PSC /ID# 202002, Caguas

00909

Clinical Research Puerto Rico /ID# 203644, San Juan

00917-3104

GCM Medical Group PSC - Hato Rey /ID# 202003, San Juan

975 17

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

036 01

Univerzitna nemocnica Martin /ID# 203851, Martin

940 34

Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240, Nové Zámky

081 01

Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373, Prešov

03010

Hospital General Universitario Alicante /ID# 200873, Alicante

08041

Hospital Santa Creu i Sant Pau /ID# 201325, Barcelona

SE 221 41

Skane University Hospital Lund /ID# 201244, Lund

413 46

Sahlgrenska University Hospital /ID# 201274, Gothenburg

118 83

Sodersjukhuset /ID# 201242, Stockholm

171 76

Karolinska University Hospital /ID# 201243, Stockholm

E1 2ES

Barts Health NHS Trust /ID# 201044, London

SE1 9RT

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

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

OX3 9DU

Oxford University Hospitals NHS Foundation Trust /ID# 202052, Oxford

DD2 1UB

NHS Tayside /ID# 202081, Dundee

G12 0XH

NHS Greater Glasgow and Clyde /ID# 201374, Glasgow

LS9 7TF

Leeds Teaching Hospitals NHS Trust /ID# 201106, Leeds

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY