A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
NCT ID: NCT06389136
Last Updated: 2026-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2024-06-12
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Period 1: Upadacitinib Open Label Treatment
Participants randomly assigned to receive Upadacitinib 15mg tablet once per day.
Based on clinical response, participants randomized to Upadacitinib 15mg may have their dose increased to Upadacitinib 30mg starting at Week 2.
Upadacitinib 15mg Dose
Oral tablet
Upadacitinib 30mg Dose
Oral tablet
Period 1: Dupilumab Open Label Treatment
Participants randomly assigned to receive Dupilumab 300mg SC injection once every other week for 8 weeks.
Dupilumab 300mg Dose
Subcutaneous (SC) injection
Period 2 Open Label: Upadacitinib < EASI 75 response
Participants that were receiving Upadacitinib 15mg or 30mg and completed Period 1, will be allocated or continue to receive oral doses of Upadacitinib 30mg in Period 2 with a clinical response of \< EASI 75 at Week 8
Upadacitinib 30mg Dose
Oral tablet
Period 2 Open Label: Upadacitinib ≥ EASI 75 Response
Participants that were receiving Upadacitinib 15mg or 30mg and completed Period 1, will continue to receive the same oral doses of Upadacitinib in Period 2 with a clinical response of ≥ EASI 75 at Week 8
Upadacitinib 15mg Dose
Oral tablet
Upadacitinib 30mg Dose
Oral tablet
Period 2 Open Label: Dupilumab ≥ EASI 75 Response
Participants that were receiving Dupilumab 300mg and completed Period 1, will continue to receive Dupilumab 300mg SC injection in Period 2 with a clinical response of ≥ EASI 75 at Week 8
Dupilumab 300mg Dose
Subcutaneous (SC) injection
Period 2 Open Label Period: Dupilumab < EASI 75 Response
Participants that were receiving Dupilumab 300mg SC injections and completed Period 1, will receive oral doses of Upadacitinib 15mg in Period 2 with a clinical response of \< EASI 75 at Week 8
Upadacitinib 15mg Dose
Oral tablet
Interventions
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Upadacitinib 15mg Dose
Oral tablet
Dupilumab 300mg Dose
Subcutaneous (SC) injection
Upadacitinib 30mg Dose
Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant meets all the following disease activity criteria at Baseline Visit:
* Eczema Area and Severity Index (EASI) score \>= 12;
* validated Investigator´s Global Assessment for AD (vIGA-AD) score \>= 3;
* Body surface area (BSA) involvement of \>= 10% in a majority of subjects (\>= 50% of the overall study population)
* Baseline weekly average of daily Worst Pruritus-Numerical Rating Scale (WP-NRS) \>= 4. Note: The Baseline weekly average of daily WP-NRS will be calculated from the 7 consecutive days immediately preceding the Baseline Visit. A minimum of 4 daily scores out of the 7 days is needed.
* Inadequate response to dupilumab treatment after at least 4 months of current use.
* Particpant has applied a topical emollient (an additive-free, bland emollient moisturizer) twice daily for at least 7 days before the Baseline Visit and for the duration of the study. Note: Subject may use prescription moisturizers or moisturizers containing ceramide, urea, filaggrin degradation products or hyaluronic acid if such moisturizers were initiated before the Screening visit.
Exclusion Criteria
* Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or would interfere with assessment of AD lesions;
* Two or more past episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
* One or more past episodes of disseminated herpes simplex (including eczema herpeticum);
* HIV infection defined as confirmed positive anti- HIV Ab test;
* Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV);
* Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual);
* For Japan: Positive result of beta-D-glucan (screening for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period;
* Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;
* Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study;
* COVID-19 infection: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status.
* At Baseline any of the following medical diseases or disorders:
* Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery or venous thromboembolism;
* Any unstable clinical condition which, in the opinion of the investigator would put the subject at risk by participating in the protocol;
* Diagnosed active parasitic infection, suspected or high risk of parasitic infection unless clinical (and if necessary) laboratory assessment have ruled out active infection before randomization;
* History of an organ transplant which requires continued immunosuppression;
* History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;
* History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;
* Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery including sleeve gastrectomy; subjects with a history of gastric banding/segmentation are not excluded;
* History of malignancy except for successfully treated NMSC or localized carcinoma in situ of the cervix.
18 Years
63 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Clinical Trials Institute - Northwest Arkansas /ID# 267290
Fayetteville, Arkansas, United States
Private Practice - Dr. Tooraj Raoof /ID# 263849
Encino, California, United States
First OC Dermatology /ID# 263349
Fountain Valley, California, United States
NorCal Medical Research /ID# 278397
Greenbrae, California, United States
Allergy & Asthma Associates of Southern California - Mission Viejo /ID# 266574
Mission Viejo, California, United States
Dermatologist Medical Group of North County- Profound Research /ID# 266512
Oceanside, California, United States
Stanford University School of Medicine - Redwood City /ID# 263776
Redwood City, California, United States
Integrative Skin Science and Research /ID# 264537
Sacramento, California, United States
West Dermatology La Jolla /ID# 265014
San Diego, California, United States
Clinical Trials Research Institute /ID# 263846
Thousand Oaks, California, United States
Yale University School of Medicine /ID# 263836
New Haven, Connecticut, United States
Clearlyderm Dermatology - West Boca /ID# 264923
Boca Raton, Florida, United States
Skin Care Research Boca Raton /ID# 263733
Boca Raton, Florida, United States
Apex Clinical Trials /ID# 263747
Brandon, Florida, United States
TrueBlue Clinical Research /ID# 265037
Brandon, Florida, United States
Life Clinical Trials /ID# 267195
Coral Springs, Florida, United States
Revival Research - Doral /ID# 263541
Doral, Florida, United States
Skin Care Research - Hollywood /ID# 263739
Hollywood, Florida, United States
Solutions Through Advanced Research /ID# 263392
Jacksonville, Florida, United States
GSI Clinical Research, LLC /ID# 263760
Margate, Florida, United States
Research Associates of South Florida /ID# 267291
Miami, Florida, United States
International Dermatology Research /ID# 264961
Miami, Florida, United States
Sullivan Dermatology /ID# 263537
Miami, Florida, United States
Lenus Research and Medical Group /ID# 263779
Miami, Florida, United States
Quality Research of South Florida /ID# 266496
Miami Lakes, Florida, United States
Global Clinical Professionals (GCP) /ID# 266474
St. Petersburg, Florida, United States
Skin Care Research - Tampa /ID# 263750
Tampa, Florida, United States
Alliance Clinical Research of Tampa /ID# 264531
Tampa, Florida, United States
Encore Medical Research - Weston /ID# 278491
Weston, Florida, United States
Centricity Research Columbus Dermatology /ID# 266529
Columbus, Georgia, United States
Cleaver Medical Group Dermatology /ID# 263788
Dawsonville, Georgia, United States
Georgia Skin & Cancer Clinic /ID# 267199
Savannah, Georgia, United States
Treasure Valley Medical Research /ID# 263738
Boise, Idaho, United States
DeNova Research /ID# 264513
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine /ID# 264983
Chicago, Illinois, United States
Dawes Fretzin, LLC /ID# 264534
Indianapolis, Indiana, United States
Options Research Group /ID# 264564
West Lafayette, Indiana, United States
Dermatology Specialists Research (DS Research) - Kentucky /ID# 263388
Louisville, Kentucky, United States
Velocity Clinical Research at The Dermatology Clinic - Baton Rouge /ID# 267169
Baton Rouge, Louisiana, United States
Boston Specialists /ID# 265810
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 263703
Boston, Massachusetts, United States
Beacon Clinical Research /ID# 263843
Quincy, Massachusetts, United States
Great Lakes Research Group - Bay City /ID# 263535
Bay City, Michigan, United States
Henry Ford Medical Center - New Center One /ID# 263522
Detroit, Michigan, United States
Onyx Clinical Research - Flint - South Linden Road /ID# 267773
Flint, Michigan, United States
MediSearch Clinical Trials /ID# 263579
Saint Joseph, Missouri, United States
Physician Research Collaboration, LLC /ID# 263583
Lincoln, Nebraska, United States
Skin Specialists /ID# 263345
Omaha, Nebraska, United States
Skin Cancer and Dermatology Institute - Reno /ID# 263771
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263840
Lebanon, New Hampshire, United States
Forest Hills Dermatology Group @ Union Turnpike /ID# 263755
Kew Gardens, New York, United States
Equity Medical, LLC /ID# 265814
New York, New York, United States
Weill Cornell Medicine /ID# 265793
New York, New York, United States
Piedmont Plastic Surgery and Dermatology /ID# 266545
Huntersville, North Carolina, United States
Vital Prospects Clinical Research Institute - Tulsa /ID# 263645
Tulsa, Oklahoma, United States
Oregon Health and Science University /ID# 263736
Portland, Oregon, United States
Dermatology Partners /ID# 264972
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center /ID# 264526
Pittsburgh, Pennsylvania, United States
Dermatology Associates of Plymouth Meeting /ID# 267286
Plymouth Meeting, Pennsylvania, United States
Medical University of South Carolina /ID# 263655
Charleston, South Carolina, United States
ADCS - Spartanburg /ID# 267185
Spartanburg, South Carolina, United States
Health Concepts /ID# 263383
Rapid City, South Dakota, United States
Arlington Research Center, Inc /ID# 263665
Arlington, Texas, United States
Orion Clinical Research /ID# 263658
Austin, Texas, United States
Bellaire Dermatology Associates /ID# 263794
Bellaire, Texas, United States
Studies in Dermatology LLC /ID# 263335
Cypress, Texas, United States
Dermatology Treatment and Research Center /ID# 265812
Dallas, Texas, United States
Modern Research Associates /ID# 263852
Dallas, Texas, United States
The Dermatology Institute of South Texas /ID# 267332
McAllen, Texas, United States
Sms Clinical Research /ID# 278676
Mesquite, Texas, United States
Texas Dermatology Research Center /ID# 264528
Plano, Texas, United States
Stride Clinical Research /ID# 267331
Sugar Land, Texas, United States
The Woodlands Dermatology Associates /ID# 266547
The Woodlands, Texas, United States
Dermatology Associates of Tyler /ID# 264980
Tyler, Texas, United States
West Virginia Research Institute - Morgantown /ID# 264930
Morgantown, West Virginia, United States
Dermatology Research Institute - Blackfoot Trail /ID# 270450
Calgary, Alberta, Canada
Stratica Medical /ID# 270466
Edmonton, Alberta, Canada
York Dermatology Clinic & Research Centre /ID# 278847
Richmond Hill, Ontario, Canada
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 277564
Québec, Quebec, Canada
Centre de Recherche Saint-Louis /ID# 271083
Québec, Quebec, Canada
Centro de Inmunología y Genética CIGE SAS /ID# 266200
Medellín, Antioquia, Colombia
Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 265088
Barranquilla, Atlántico, Colombia
Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 265092
Bogotá, Cundinamarca, Colombia
Unidad Integral de Endocrinologia (UNIENDO) /ID# 266970
Bogotá, Cundinamarca, Colombia
Ichinomiya Municipal Hospital /ID# 265068
Ichinomiya, Aichi-ken, Japan
Takeoka Dermatology Clinic /ID# 264055
Marugame, Kagawa-ken, Japan
Kawasaki Medical School Hospital /ID# 266164
Kurashiki, Okayama-ken, Japan
Dokkyo Medical University Hospital /ID# 265431
Mibu, Tochigi, Japan
Ogikubo Hospital /ID# 278350
Suginami-Ku, Tokyo, Japan
Tachikawa Dermatology Clinic /ID# 271912
Tachikawa-shi, Tokyo, Japan
Yamanashi Prefectural Central Hospital /ID# 278052
Kofu, Yamanashi, Japan
Katahira Dermatology Urology Clinic /ID# 264403
Kagoshima, , Japan
NTT Medical Center Tokyo /ID# 265104
Tokyo, , Japan
Teikyo University Hospital /ID# 265126
Tokyo, , Japan
SCB Research Center /ID# 263217
Bayamón, , Puerto Rico
Private Practice - Dr. Samuel Sanchez /ID# 263199
Caguas, , Puerto Rico
Private Practice - Dr. Alma Cruz /ID# 263216
Carolina, , Puerto Rico
Clinical Research Puerto Rico /ID# 263197
San Juan, , Puerto Rico
GCM Medical Group, PSC /ID# 263218
San Juan, , Puerto Rico
CMRC Headlands LLC /ID# 267163
San Juan, , Puerto Rico
Korea University Ansan Hospital /ID# 263330
Ansan-si, Gyeonggido, South Korea
Soon Chun Hyang University Hospital Bucheon /ID# 263331
Bucheon-si, Gyeonggido, South Korea
Ajou University Hospital /ID# 263328
Suwon, Gyeonggido, South Korea
Seoul National University Hospital /ID# 263329
Seoul, Seoul Teugbyeolsi, South Korea
Konkuk University Medical Center /ID# 263327
Seoul, Seoul Teugbyeolsi, South Korea
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2025-523347-35
Identifier Type: OTHER
Identifier Source: secondary_id
M24-601
Identifier Type: -
Identifier Source: org_study_id
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