Actively Recruiting
A Phase 3b/4 Study to Evaluate the Efficacy and Safety of Upadacitinib in Adults With Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab
Led by AbbVie · Updated on 2026-05-22
200
Participants Needed
127
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the efficacy and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. The study targets approximately 200 participants aged 18 to less than 64 years who have chronic AD with symptoms ongoing for at least three years and significant disease activity. The trial is sponsored by AbbVie and conducted worldwide across up to 130 sites. The study is divided into two periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg oral tablets once daily or dupilumab 300mg subcutaneous injections every other week for 8 weeks. Those on upadacitinib 15mg may have their dose increased to 30mg after two weeks based on clinical response. In Period 2, lasting 24 weeks, participants continue or adjust their doses depending on their Eczema Area and Severity Index (EASI) response. Participants originally on dupilumab who show less than EASI 75 response will switch to upadacitinib 15mg. Participants will attend regular visits throughout the 35-day screening period, the 8-week open-label Period 1, and the 24-week open-label Period 2, followed by a 30-day safety follow-up. Assessments include medical exams, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The primary outcome is the proportion of participants achieving at least a 90% reduction in EASI score by Week 8. Secondary outcomes include improvements in itch severity measured by the Worst Pruritus Numerical Rating Scale.
CONDITIONS
Brief Title
A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to less than 64 years with chronic atopic dermatitis lasting at least 3 years
- Eczema Area and Severity Index (EASI) score of 12 or higher at baseline
- Investigator's Global Assessment for AD score of 3 or higher
- Body surface area involvement of 10% or more in most participants
- Baseline weekly average Worst Pruritus-Numerical Rating Scale (WP-NRS) score of 4 or higher
- Inadequate response to dupilumab after at least 4 months of use
- Use of a bland topical emollient moisturizer twice daily for at least 7 days before baseline and during the study
You will not qualify if you...
- Presence of other active skin diseases or infections requiring systemic treatment within 4 weeks before baseline
- History of two or more herpes zoster episodes or disseminated herpes zoster
- History of disseminated herpes simplex infections
- Confirmed HIV infection
- Current or past hepatitis B or C virus infection
- Active tuberculosis or meeting 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 unsuitable for study participation
- Recent serious cardiovascular events within 6 months
- Unstable clinical conditions posing risk for participation
- Diagnosed active parasitic infections or high risk for such infections
- History of organ transplant requiring immunosuppression
- Allergic reaction or sensitivity to study drug components
- History or high risk of gastrointestinal perforation
- Conditions interfering with drug absorption such as short bowel syndrome or gastric bypass surgery
- History of malignancy except treated non-melanoma skin cancer or localized cervical carcinoma in situ
- Recent COVID-19 infection without resolution criteria met
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either oral Upadacitinib or Dupilumab injections to manage moderate to severe atopic dermatitis. Dosage and treatment may be adjusted based on clinical response.
Weekly visits for up to 8 weeks
Duration - Duration varies based on clinical response and continuation in Period 2
Based on Week 8 response, participants continue or adjust their treatment with Upadacitinib or Dupilumab in an open-label period.
Visits scheduled according to clinical response during Period 2
Trial Site Locations
Total: 127 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
Comprehensive Dermatology Center of Pasadena /ID# 281014
Pasadena, California, United States, 91105
Actively Recruiting
10
Stanford University School of Medicine - Redwood City /ID# 263776
Redwood City, California, United States, 94063
Actively Recruiting
11
Integrative Skin Science and Research /ID# 264537
Sacramento, California, United States, 95815
Actively Recruiting
12
West Dermatology La Jolla /ID# 265014
San Diego, California, United States, 92121
Actively Recruiting
13
Clinical Trials Research Institute /ID# 263846
Thousand Oaks, California, United States, 91320
Actively Recruiting
14
Yale University School of Medicine /ID# 263836
New Haven, Connecticut, United States, 06510
Actively Recruiting
15
Clearlyderm Dermatology - West Boca /ID# 264923
Boca Raton, Florida, United States, 33428
Completed
16
Skin Care Research Boca Raton /ID# 263733
Boca Raton, Florida, United States, 33486-2269
Actively Recruiting
17
Apex Clinical Trials /ID# 263747
Brandon, Florida, United States, 33511
Completed
18
TrueBlue Clinical Research - Brandon /ID# 265037
Brandon, Florida, United States, 33511
Actively Recruiting
19
Life Clinical Trials - Coral Springs /ID# 267195
Coral Springs, Florida, United States, 33071
Actively Recruiting
20
Revival Research - Doral /ID# 263541
Doral, Florida, United States, 33122
Completed
21
FXM Clinical Research Ft. Lauderdale /ID# 280911
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
22
Skin Care Research - Hollywood /ID# 263739
Hollywood, Florida, United States, 33021-6748
Actively Recruiting
23
Solutions Through Advanced Research /ID# 263392
Jacksonville, Florida, United States, 32256
Completed
24
GSI Clinical Research, LLC /ID# 263760
Margate, Florida, United States, 33063-7011
Actively Recruiting
25
Research Associates of South Florida /ID# 267291
Miami, Florida, United States, 33134
Actively Recruiting
26
International Dermatology Research /ID# 264961
Miami, Florida, United States, 33144
Actively Recruiting
27
FAX Pharma Clinical Research /ID# 280915
Miami, Florida, United States, 33146
Actively Recruiting
28
Sullivan Dermatology /ID# 263537
Miami, Florida, United States, 33162
Actively Recruiting
29
Lenus Research and Medical Group /ID# 263779
Miami, Florida, United States, 33172
Actively Recruiting
30
Quality Research of South Florida /ID# 266496
Miami Lakes, Florida, United States, 33016
Completed
31
Fxm Clinical Research - Miramar /ID# 280934
Miramar, Florida, United States, 33027
Actively Recruiting
32
Global Clinical Professionals (GCP) /ID# 266474
St. Petersburg, Florida, United States, 33705
Actively Recruiting
33
Skin Care Research - Tampa /ID# 263750
Tampa, Florida, United States, 33607-6438
Actively Recruiting
34
Alliance Clinical Research of Tampa /ID# 264531
Tampa, Florida, United States, 33615
Actively Recruiting
35
Encore Medical Research - Weston /ID# 278491
Weston, Florida, United States, 33331
Actively Recruiting
36
Centricity Research Columbus Dermatology /ID# 266529
Columbus, Georgia, United States, 31904
Actively Recruiting
37
Cleaver Medical Group Dermatology /ID# 263788
Dawsonville, Georgia, United States, 30534
Actively Recruiting
38
Georgia Skin & Cancer Clinic /ID# 267199
Savannah, Georgia, United States, 31419
Completed
39
Treasure Valley Medical Research /ID# 263738
Boise, Idaho, United States, 83706
Actively Recruiting
40
DeNova Research /ID# 264513
Chicago, Illinois, United States, 60610
Actively Recruiting
41
Northwestern University Feinberg School of Medicine /ID# 264983
Chicago, Illinois, United States, 60611-2927
Actively Recruiting
42
Dawes Fretzin /ID# 264534
Indianapolis, Indiana, United States, 46256
Completed
43
Options Research Group /ID# 264564
West Lafayette, Indiana, United States, 47906
Actively Recruiting
44
Dermatology Specialists Research (DS Research) - Kentucky /ID# 263388
Louisville, Kentucky, United States, 40241
Completed
45
Velocity Clinical Research at The Dermatology Clinic - Baton Rouge /ID# 267169
Baton Rouge, Louisiana, United States, 70808-4691
Completed
46
Boston Specialists /ID# 265810
Boston, Massachusetts, United States, 02111-1901
Actively Recruiting
47
Beth Israel Deaconess Medical Center /ID# 263703
Boston, Massachusetts, United States, 02215
Completed
48
Beacon Clinical Research /ID# 263843
Quincy, Massachusetts, United States, 02169
Actively Recruiting
49
Great Lakes Research Group - Bay City /ID# 263535
Bay City, Michigan, United States, 48706
Completed
50
Henry Ford Medical Center - New Center One /ID# 263522
Detroit, Michigan, United States, 48202-3046
Actively Recruiting
51
Onyx Clinical Research - Flint - South Linden Road /ID# 267773
Flint, Michigan, United States, 48532
Completed
52
MediSearch Clinical Trials /ID# 263579
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
53
Physician Research Collaboration, LLC /ID# 263583
Lincoln, Nebraska, United States, 68516
Actively Recruiting
54
Skin Specialists /ID# 263345
Omaha, Nebraska, United States, 68144
Actively Recruiting
55
Las Vegas Dermatology /ID# 265801
Las Vegas, Nevada, United States, 89144
Actively Recruiting
56
Skin Cancer and Dermatology Institute - Reno /ID# 263771
Reno, Nevada, United States, 89509
Actively Recruiting
57
Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263840
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
58
Forest Hills Dermatology Group @ Union Turnpike /ID# 263755
Kew Gardens, New York, United States, 11415
Completed
59
Equity Medical, LLC /ID# 265814
New York, New York, United States, 10023-7340
Actively Recruiting
60
Weill Cornell Medicine /ID# 265793
New York, New York, United States, 10065
Actively Recruiting
61
Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 266545
Huntersville, North Carolina, United States, 28078-7961
Actively Recruiting
62
Vital Prospects Clinical Research Institute - Tulsa /ID# 263645
Tulsa, Oklahoma, United States, 74136
Completed
63
Oregon Health and Science University /ID# 263736
Portland, Oregon, United States, 97239
Actively Recruiting
64
Clinical Research of Philadelphia /ID# 264972
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
65
University of Pittsburgh Medical Center /ID# 264526
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
66
Dermatology Associates of Plymouth Meeting /ID# 267286
Plymouth Meeting, Pennsylvania, United States, 19462
Actively Recruiting
67
Medical University of South Carolina /ID# 263655
Charleston, South Carolina, United States, 29425
Actively Recruiting
68
Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267185
Spartanburg, South Carolina, United States, 29307
Actively Recruiting
69
Health Concepts /ID# 263383
Rapid City, South Dakota, United States, 57702
Actively Recruiting
70
Arlington Research Center, Inc /ID# 263665
Arlington, Texas, United States, 76011
Actively Recruiting
71
Orion Clinical Research /ID# 263658
Austin, Texas, United States, 78759
Completed
72
Bellaire Dermatology Associates /ID# 263794
Bellaire, Texas, United States, 77401
Completed
73
Studies in Dermatology LLC /ID# 263335
Cypress, Texas, United States, 77429
Actively Recruiting
74
Dermatology Treatment and Research Center /ID# 265812
Dallas, Texas, United States, 75230
Actively Recruiting
75
Modern Research Associates /ID# 263852
Dallas, Texas, United States, 75231
Actively Recruiting
76
BRCR Global - Katy /ID# 267304
Katy, Texas, United States, 77450
Actively Recruiting
77
The Dermatology Institute of South Texas /ID# 267332
McAllen, Texas, United States, 78501
Completed
78
Sms Clinical Research /ID# 278676
Mesquite, Texas, United States, 75149
Actively Recruiting
79
Texas Dermatology Research Center /ID# 264528
Plano, Texas, United States, 75025
Completed
80
Stride Clinical Research /ID# 267331
Sugar Land, Texas, United States, 77479
Actively Recruiting
81
The Woodlands Dermatology Associates /ID# 266547
The Woodlands, Texas, United States, 77380
Actively Recruiting
82
Dermatology Associates of Tyler /ID# 264980
Tyler, Texas, United States, 75703
Actively Recruiting
83
West Virginia Research Institute - Morgantown /ID# 264930
Morgantown, West Virginia, United States, 26505
Actively Recruiting
84
Dermatology Research Institute - Blackfoot Trail /ID# 270450
Calgary, Alberta, Canada, T2J 7E1
Actively Recruiting
85
Stratica Medical /ID# 270466
Edmonton, Alberta, Canada, T5K 2V4
Actively Recruiting
86
York Dermatology Clinic & Research Centre /ID# 278847
Richmond Hill, Ontario, Canada, L4C 9M7
Actively Recruiting
87
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 277564
Québec, Quebec, Canada, G1V 4X7
Actively Recruiting
88
Centre de Recherche Saint-Louis /ID# 271083
Québec, Quebec, Canada, G1W 4R4
Completed
89
Centro de Inmunología y Genética CIGE SAS /ID# 266200
Medellín, Antioquia, Colombia, 050012
Actively Recruiting
90
Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 265088
Barranquilla, Atlántico, Colombia, 80002
Actively Recruiting
91
Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 265092
Bogotá, Cundinamarca, Colombia, 110221
Actively Recruiting
92
Unidad Integral de Endocrinologia (UNIENDO) /ID# 266970
Bogotá, Cundinamarca, Colombia, 110221
Actively Recruiting
93
ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 278461
L’Aquila, L Aquila, Italy, 67100
Actively Recruiting
94
IRCCS Istituto Clinico Humanitas /ID# 278458
Rozzano, Lombardy, Italy, 20089
Actively Recruiting
95
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 278460
Rome, Roma, Italy, 00168
Actively Recruiting
96
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 278463
Milan, Italy, 20122
Actively Recruiting
97
Ichinomiya Municipal Hospital /ID# 265068
Ichinomiya, Aichi-ken, Japan, 491-8558
Actively Recruiting
98
Takeoka Dermatology Clinic /ID# 264055
Marugame, Kagawa-ken, Japan, 763-0074
Actively Recruiting
99
University Hospital Kyoto Prefectural University of Medicine /ID# 279353
Kyoto, Kyoto, Japan, 602-8566
Actively Recruiting
100
Kawasaki Medical School Hospital /ID# 266164
Kurashiki, Okayama-ken, Japan, 701-0192
Actively Recruiting
101
Dokkyo Medical University Hospital /ID# 265431
Mibu, Tochigi, Japan, 321-0293
Actively Recruiting
102
Ogikubo Hospital /ID# 278350
Suginami-Ku, Tokyo, Japan, 167-0035
Actively Recruiting
103
Tachikawa Dermatology Clinic /ID# 271912
Tachikawa-shi, Tokyo, Japan, 190-0023
Actively Recruiting
104
Yamanashi Prefectural Central Hospital /ID# 278052
Kofu, Yamanashi, Japan, 400-0027
Actively Recruiting
105
Katahira Dermatology Urology Clinic /ID# 264403
Kagoshima, Japan, 890-0063
Actively Recruiting
106
NTT Medical Center Tokyo /ID# 265104
Tokyo, Japan, 141-8625
Actively Recruiting
107
Teikyo University Hospital /ID# 265126
Tokyo, Japan, 173-8605
Actively Recruiting
108
SCB Research Center /ID# 263217
Bayamón, Puerto Rico, 00961
Actively Recruiting
109
Private Practice - Dr. Samuel Sanchez /ID# 263199
Caguas, Puerto Rico, 00727
Actively Recruiting
110
Private Practice - Dr. Alma Cruz /ID# 263216
Carolina, Puerto Rico, 00985
Actively Recruiting
111
Clinical Research Puerto Rico /ID# 263197
San Juan, Puerto Rico, 00909-1711
Actively Recruiting
112
GCM Medical Group, PSC /ID# 263218
San Juan, Puerto Rico, 00917
Actively Recruiting
113
CMRC Headlands LLC /ID# 267163
San Juan, Puerto Rico, 00918-3501
Actively Recruiting
114
Private Practice - Dr. Orasan Remus /ID# 278765
Cluj-Napoca, Cluj, Romania, 400006
Actively Recruiting
115
Dr Tirziu Dermato-Chirurgie SRL /ID# 278661
Timișoara, Timiș County, Romania, 300188
Actively Recruiting
116
FutureMeds S.R.L. /ID# 279203
Galati, Romania, 800183
Actively Recruiting
117
FutureMeds S.R.L. /ID# 279217
Galati, Romania, 800183
Actively Recruiting
118
Korea University Ansan Hospital /ID# 263330
Ansan-si, Gyeonggido, South Korea, 15355
Actively Recruiting
119
Soon Chun Hyang University Hospital Bucheon /ID# 263331
Bucheon-si, Gyeonggido, South Korea, 14584
Actively Recruiting
120
Ajou University Hospital - Suwon-si /ID# 263328
Suwon, Gyeonggido, South Korea, 16499
Actively Recruiting
121
Seoul National University Hospital /ID# 263329
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
122
Konkuk University Medical Center /ID# 263327
Seoul, Seoul Teugbyeolsi, South Korea, 05030
Actively Recruiting
123
Hospital Universitario Virgen de las Nieves /ID# 278316
Granada, Spain, 18014
Actively Recruiting
124
Hospital Universitario de La Princesa /ID# 278319
Madrid, Spain, 28006
Actively Recruiting
125
Hospital Universitario 12 de Octubre /ID# 278315
Madrid, Spain, 28041
Actively Recruiting
126
Consorci Hospital General Universitario de Valencia /ID# 278306
Valencia, Spain, 46014
Actively Recruiting
127
Hospital Universitari i Politecnic La Fe /ID# 278307
Valencia, Spain, 46026
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
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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