Actively Recruiting

Phase 3
Age: 18Years - 63Years
All Genders
NCT06389136

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Led by AbbVie · Updated on 2026-05-12

200

Participants Needed

126

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide. The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

CONDITIONS

Official Title

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Who Can Participate

Age: 18Years - 63Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to less than 64 years
  • Chronic atopic dermatitis with symptoms starting at least 3 years before the study
  • Eczema Area and Severity Index (EASI) score of 12 or higher at baseline
  • Investigator's Global Assessment for AD (vIGA-AD) score of 3 or higher at baseline
  • Body surface area involvement of 10% or more in most subjects
  • Average daily worst itch score of 4 or more during the week before baseline
  • Inadequate response to dupilumab after at least 4 months of use
  • Use of a bland, additive-free topical moisturizer twice daily for at least 7 days before baseline and during the study
  • Use of prescribed moisturizers started before screening visit allowed
Not Eligible

You will not qualify if you...

  • Active skin diseases or infections needing systemic treatment within 4 weeks before baseline
  • History of two or more herpes zoster episodes or any disseminated herpes zoster
  • History of disseminated herpes simplex infection
  • Confirmed HIV infection
  • Current or past infection with Hepatitis B or C viruses
  • Active tuberculosis or meet tuberculosis exclusion criteria
  • For Japan: Positive or indeterminate beta-D-glucan test for Pneumocystis jirovecii infection
  • Active infection requiring intravenous treatment within 30 days or oral/intramuscular treatment within 14 days before baseline
  • Chronic recurring or active viral infections deemed unsuitable by investigator
  • Recent COVID-19 infection without recovery as defined by study
  • Recent serious cardiovascular events or unstable clinical conditions
  • Active parasitic infection or high risk without ruled out infection
  • History of organ transplant requiring immunosuppression
  • Allergic reaction or sensitivity to study drug or related products
  • History of gastrointestinal perforation or high risk for perforation
  • Conditions interfering with drug absorption such as short bowel syndrome or gastric bypass
  • History of malignancy except treated non-melanoma skin cancer or localized cervical carcinoma in situ

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 126 locations

1

Cahaba Dermatology & Skin Health Center /ID# 263855

Birmingham, Alabama, United States, 35244

Actively Recruiting

2

One Of A Kind Clinical Research Center - Scottsdale /ID# 278675

Scottsdale, Arizona, United States, 85253

Actively Recruiting

3

Clinical Trials Institute - Northwest Arkansas /ID# 267290

Fayetteville, Arkansas, United States, 72703

Actively Recruiting

4

Private Practice - Dr. Tooraj Raoof /ID# 263849

Encino, California, United States, 91436

Actively Recruiting

5

First OC Dermatology /ID# 263349

Fountain Valley, California, United States, 92708

Actively Recruiting

6

NorCal Medical Research /ID# 278397

Greenbrae, California, United States, 94904

Actively Recruiting

7

Allergy & Asthma Associates of Southern California - Mission Viejo /ID# 266574

Mission Viejo, California, United States, 92691

Actively Recruiting

8

Dermatologist Medical Group of North County- Profound Research /ID# 266512

Oceanside, California, United States, 92056

Actively Recruiting

9

Stanford University School of Medicine - Redwood City /ID# 263776

Redwood City, California, United States, 94063

Actively Recruiting

10

Integrative Skin Science and Research /ID# 264537

Sacramento, California, United States, 95815

Actively Recruiting

11

West Dermatology La Jolla /ID# 265014

San Diego, California, United States, 92121

Actively Recruiting

12

Clinical Trials Research Institute /ID# 263846

Thousand Oaks, California, United States, 91320

Actively Recruiting

13

Yale University School of Medicine /ID# 263836

New Haven, Connecticut, United States, 06510

Actively Recruiting

14

Clearlyderm Dermatology - West Boca /ID# 264923

Boca Raton, Florida, United States, 33428

Completed

15

Skin Care Research Boca Raton /ID# 263733

Boca Raton, Florida, United States, 33486-2269

Actively Recruiting

16

Apex Clinical Trials /ID# 263747

Brandon, Florida, United States, 33511

Completed

17

TrueBlue Clinical Research /ID# 265037

Brandon, Florida, United States, 33511

Actively Recruiting

18

Life Clinical Trials /ID# 267195

Coral Springs, Florida, United States, 33071

Actively Recruiting

19

Revival Research - Doral /ID# 263541

Doral, Florida, United States, 33122

Completed

20

FXM Clinical Research Ft. Lauderdale /ID# 280911

Fort Lauderdale, Florida, United States, 33308

Actively Recruiting

21

Skin Care Research - Hollywood /ID# 263739

Hollywood, Florida, United States, 33021-6748

Actively Recruiting

22

Solutions Through Advanced Research /ID# 263392

Jacksonville, Florida, United States, 32256

Completed

23

GSI Clinical Research, LLC /ID# 263760

Margate, Florida, United States, 33063-7011

Actively Recruiting

24

Research Associates of South Florida /ID# 267291

Miami, Florida, United States, 33134

Actively Recruiting

25

International Dermatology Research /ID# 264961

Miami, Florida, United States, 33144

Actively Recruiting

26

FAX Pharma Clinical Research /ID# 280915

Miami, Florida, United States, 33146

Actively Recruiting

27

Sullivan Dermatology /ID# 263537

Miami, Florida, United States, 33162

Actively Recruiting

28

Lenus Research and Medical Group /ID# 263779

Miami, Florida, United States, 33172

Actively Recruiting

29

Quality Research of South Florida /ID# 266496

Miami Lakes, Florida, United States, 33016

Completed

30

Fxm Clinical Research - Miramar /ID# 280934

Miramar, Florida, United States, 33027

Actively Recruiting

31

Global Clinical Professionals (GCP) /ID# 266474

St. Petersburg, Florida, United States, 33705

Actively Recruiting

32

Skin Care Research - Tampa /ID# 263750

Tampa, Florida, United States, 33607-6438

Actively Recruiting

33

Alliance Clinical Research of Tampa /ID# 264531

Tampa, Florida, United States, 33615

Actively Recruiting

34

Encore Medical Research - Weston /ID# 278491

Weston, Florida, United States, 33331

Actively Recruiting

35

Centricity Research Columbus Dermatology /ID# 266529

Columbus, Georgia, United States, 31904

Actively Recruiting

36

Cleaver Medical Group Dermatology /ID# 263788

Dawsonville, Georgia, United States, 30534

Actively Recruiting

37

Georgia Skin & Cancer Clinic /ID# 267199

Savannah, Georgia, United States, 31419

Completed

38

Treasure Valley Medical Research /ID# 263738

Boise, Idaho, United States, 83706

Actively Recruiting

39

DeNova Research /ID# 264513

Chicago, Illinois, United States, 60610

Actively Recruiting

40

Northwestern University Feinberg School of Medicine /ID# 264983

Chicago, Illinois, United States, 60611-2927

Actively Recruiting

41

Dawes Fretzin, LLC /ID# 264534

Indianapolis, Indiana, United States, 46256

Completed

42

Options Research Group /ID# 264564

West Lafayette, Indiana, United States, 47906

Actively Recruiting

43

Dermatology Specialists Research (DS Research) - Kentucky /ID# 263388

Louisville, Kentucky, United States, 40241

Completed

44

Velocity Clinical Research at The Dermatology Clinic - Baton Rouge /ID# 267169

Baton Rouge, Louisiana, United States, 70808-4691

Completed

45

Boston Specialists /ID# 265810

Boston, Massachusetts, United States, 02111-1901

Actively Recruiting

46

Beth Israel Deaconess Medical Center /ID# 263703

Boston, Massachusetts, United States, 02215

Completed

47

Beacon Clinical Research /ID# 263843

Quincy, Massachusetts, United States, 02169

Actively Recruiting

48

Great Lakes Research Group - Bay City /ID# 263535

Bay City, Michigan, United States, 48706

Completed

49

Henry Ford Medical Center - New Center One /ID# 263522

Detroit, Michigan, United States, 48202-3046

Actively Recruiting

50

Onyx Clinical Research - Flint - South Linden Road /ID# 267773

Flint, Michigan, United States, 48532

Completed

51

MediSearch Clinical Trials /ID# 263579

Saint Joseph, Missouri, United States, 64506

Actively Recruiting

52

Physician Research Collaboration, LLC /ID# 263583

Lincoln, Nebraska, United States, 68516

Actively Recruiting

53

Skin Specialists /ID# 263345

Omaha, Nebraska, United States, 68144

Actively Recruiting

54

Las Vegas Dermatology /ID# 265801

Las Vegas, Nevada, United States, 89144

Actively Recruiting

55

Skin Cancer and Dermatology Institute - Reno /ID# 263771

Reno, Nevada, United States, 89509

Actively Recruiting

56

Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263840

Lebanon, New Hampshire, United States, 03766

Actively Recruiting

57

Forest Hills Dermatology Group @ Union Turnpike /ID# 263755

Kew Gardens, New York, United States, 11415

Completed

58

Equity Medical, LLC /ID# 265814

New York, New York, United States, 10023-7340

Actively Recruiting

59

Weill Cornell Medicine /ID# 265793

New York, New York, United States, 10065

Actively Recruiting

60

Piedmont Plastic Surgery and Dermatology /ID# 266545

Huntersville, North Carolina, United States, 28078-7961

Actively Recruiting

61

Vital Prospects Clinical Research Institute - Tulsa /ID# 263645

Tulsa, Oklahoma, United States, 74136

Completed

62

Oregon Health and Science University /ID# 263736

Portland, Oregon, United States, 97239

Actively Recruiting

63

Clinical Research of Philadelphia /ID# 264972

Philadelphia, Pennsylvania, United States, 19114

Actively Recruiting

64

University of Pittsburgh Medical Center /ID# 264526

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

65

Dermatology Associates of Plymouth Meeting /ID# 267286

Plymouth Meeting, Pennsylvania, United States, 19462

Actively Recruiting

66

Medical University of South Carolina /ID# 263655

Charleston, South Carolina, United States, 29425

Actively Recruiting

67

Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267185

Spartanburg, South Carolina, United States, 29307

Actively Recruiting

68

Health Concepts /ID# 263383

Rapid City, South Dakota, United States, 57702

Actively Recruiting

69

Arlington Research Center, Inc /ID# 263665

Arlington, Texas, United States, 76011

Actively Recruiting

70

Orion Clinical Research /ID# 263658

Austin, Texas, United States, 78759

Completed

71

Bellaire Dermatology Associates /ID# 263794

Bellaire, Texas, United States, 77401

Completed

72

Studies in Dermatology LLC /ID# 263335

Cypress, Texas, United States, 77429

Actively Recruiting

73

Dermatology Treatment and Research Center /ID# 265812

Dallas, Texas, United States, 75230

Actively Recruiting

74

Modern Research Associates /ID# 263852

Dallas, Texas, United States, 75231

Actively Recruiting

75

BRCR Global /ID# 267304

Katy, Texas, United States, 77450

Actively Recruiting

76

The Dermatology Institute of South Texas /ID# 267332

McAllen, Texas, United States, 78501

Completed

77

Sms Clinical Research /ID# 278676

Mesquite, Texas, United States, 75149

Actively Recruiting

78

Texas Dermatology Research Center /ID# 264528

Plano, Texas, United States, 75025

Completed

79

Stride Clinical Research /ID# 267331

Sugar Land, Texas, United States, 77479

Actively Recruiting

80

The Woodlands Dermatology Associates /ID# 266547

The Woodlands, Texas, United States, 77380

Actively Recruiting

81

Dermatology Associates of Tyler /ID# 264980

Tyler, Texas, United States, 75703

Actively Recruiting

82

West Virginia Research Institute - Morgantown /ID# 264930

Morgantown, West Virginia, United States, 26505

Actively Recruiting

83

Dermatology Research Institute - Blackfoot Trail /ID# 270450

Calgary, Alberta, Canada, T2J 7E1

Actively Recruiting

84

Stratica Medical /ID# 270466

Edmonton, Alberta, Canada, T5K 2V4

Actively Recruiting

85

York Dermatology Clinic & Research Centre /ID# 278847

Richmond Hill, Ontario, Canada, L4C 9M7

Actively Recruiting

86

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 277564

Québec, Quebec, Canada, G1V 4X7

Actively Recruiting

87

Centre de Recherche Saint-Louis /ID# 271083

Québec, Quebec, Canada, G1W 4R4

Actively Recruiting

88

Centro de Inmunología y Genética CIGE SAS /ID# 266200

Medellín, Antioquia, Colombia, 050012

Actively Recruiting

89

Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 265088

Barranquilla, Atlántico, Colombia, 80002

Actively Recruiting

90

Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 265092

Bogotá, Cundinamarca, Colombia, 110221

Actively Recruiting

91

Unidad Integral de Endocrinologia (UNIENDO) /ID# 266970

Bogotá, Cundinamarca, Colombia, 110221

Actively Recruiting

92

ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 278461

L’Aquila, L Aquila, Italy, 67100

Actively Recruiting

93

IRCCS Istituto Clinico Humanitas /ID# 278458

Rozzano, Lombardy, Italy, 20089

Actively Recruiting

94

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 278460

Rome, Roma, Italy, 00168

Actively Recruiting

95

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 278463

Milan, Italy, 20122

Actively Recruiting

96

Ichinomiya Municipal Hospital /ID# 265068

Ichinomiya, Aichi-ken, Japan, 491-8558

Actively Recruiting

97

Takeoka Dermatology Clinic /ID# 264055

Marugame, Kagawa-ken, Japan, 763-0074

Actively Recruiting

98

University Hospital Kyoto Prefectural University of Medicine /ID# 279353

Kyoto, Kyoto, Japan, 602-8566

Actively Recruiting

99

Kawasaki Medical School Hospital /ID# 266164

Kurashiki, Okayama-ken, Japan, 701-0192

Actively Recruiting

100

Dokkyo Medical University Hospital /ID# 265431

Mibu, Tochigi, Japan, 321-0293

Actively Recruiting

101

Ogikubo Hospital /ID# 278350

Suginami-Ku, Tokyo, Japan, 167-0035

Actively Recruiting

102

Tachikawa Dermatology Clinic /ID# 271912

Tachikawa-shi, Tokyo, Japan, 190-0023

Actively Recruiting

103

Yamanashi Prefectural Central Hospital /ID# 278052

Kofu, Yamanashi, Japan, 400-0027

Actively Recruiting

104

Katahira Dermatology Urology Clinic /ID# 264403

Kagoshima, Japan, 890-0063

Actively Recruiting

105

NTT Medical Center Tokyo /ID# 265104

Tokyo, Japan, 141-8625

Actively Recruiting

106

Teikyo University Hospital /ID# 265126

Tokyo, Japan, 173-8605

Actively Recruiting

107

SCB Research Center /ID# 263217

Bayamón, Puerto Rico, 00961

Actively Recruiting

108

Private Practice - Dr. Samuel Sanchez /ID# 263199

Caguas, Puerto Rico, 00727

Actively Recruiting

109

Private Practice - Dr. Alma Cruz /ID# 263216

Carolina, Puerto Rico, 00985

Actively Recruiting

110

Clinical Research Puerto Rico /ID# 263197

San Juan, Puerto Rico, 00909-1711

Actively Recruiting

111

GCM Medical Group, PSC /ID# 263218

San Juan, Puerto Rico, 00917

Actively Recruiting

112

CMRC Headlands LLC /ID# 267163

San Juan, Puerto Rico, 00918-3501

Actively Recruiting

113

Private Practice - Dr. Orasan Remus /ID# 278765

Cluj-Napoca, Cluj, Romania, 400006

Actively Recruiting

114

Dr Tirziu Dermato-Chirurgie SRL /ID# 278661

Timișoara, Timiș County, Romania, 300188

Actively Recruiting

115

FutureMeds S.R.L. /ID# 279203

Galati, Romania, 800183

Actively Recruiting

116

FutureMeds S.R.L. /ID# 279217

Galati, Romania, 800183

Actively Recruiting

117

Korea University Ansan Hospital /ID# 263330

Ansan-si, Gyeonggido, South Korea, 15355

Actively Recruiting

118

Soon Chun Hyang University Hospital Bucheon /ID# 263331

Bucheon-si, Gyeonggido, South Korea, 14584

Actively Recruiting

119

Ajou University Hospital /ID# 263328

Suwon, Gyeonggido, South Korea, 16499

Actively Recruiting

120

Seoul National University Hospital /ID# 263329

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

121

Konkuk University Medical Center /ID# 263327

Seoul, Seoul Teugbyeolsi, South Korea, 05030

Actively Recruiting

122

Hospital Universitario Virgen de las Nieves /ID# 278316

Granada, Spain, 18014

Actively Recruiting

123

Hospital Universitario de La Princesa /ID# 278319

Madrid, Spain, 28006

Actively Recruiting

124

Hospital Universitario 12 de Octubre /ID# 278315

Madrid, Spain, 28041

Actively Recruiting

125

Consorci Hospital General Universitario de Valencia /ID# 278306

Valencia, Spain, 46014

Actively Recruiting

126

Hospital Universitari i Politècnic La Fe /ID# 278307

Valencia, Spain, 46026

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab | DecenTrialz