Upadacitinib 15mg Dose: Oral tablet
Dupilumab 300mg Dose: Subcutaneous (SC) injection
Upadacitinib 30mg Dose: Oral tablet
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Cahaba Dermatology & Skin Health Center /ID# 263855 | Birmingham | Alabama | Recruiting |
| One Of A Kind Clinical Research Center - Scottsdale /ID# 278675 | Scottsdale | Arizona | Recruiting |
| Clinical Trials Institute - Northwest Arkansas /ID# 267290 | Fayetteville | Arkansas | Recruiting |
| Exalt Clinical Research /ID# 281611 | Chula Vista | California | Recruiting |
| Private Practice - Dr. Tooraj Raoof /ID# 263849 | Encino | California | Recruiting |
| First OC Dermatology /ID# 263349 | Fountain Valley | California | Recruiting |
| NorCal Medical Research /ID# 278397 | Greenbrae | California | Recruiting |
| Allergy & Asthma Associates of Southern California - Mission Viejo /ID# 266574 | Mission Viejo | California | Recruiting |
| Dermatologist Medical Group of North County- Profound Research /ID# 266512 | Oceanside | California | Recruiting |
| Comprehensive Dermatology Center of Pasadena /ID# 281014 | Pasadena | California | Recruiting |
| Stanford University School of Medicine - Redwood City /ID# 263776 | Redwood City | California | Recruiting |
| Integrative Skin Science and Research /ID# 264537 | Sacramento | California | Recruiting |
| West Dermatology La Jolla /ID# 265014 | San Diego | California | Recruiting |
| Clinical Trials Research Institute /ID# 263846 | Thousand Oaks | California | Recruiting |
| Yale University School of Medicine /ID# 263836 | New Haven | Connecticut | Recruiting |
| Clearlyderm Dermatology - West Boca /ID# 264923 | Boca Raton | Florida | Completed |
| Skin Care Research Boca Raton /ID# 263733 | Boca Raton | Florida | Recruiting |
| Apex Clinical Trials /ID# 263747 | Brandon | Florida | Completed |
| TrueBlue Clinical Research - Brandon /ID# 265037 | Brandon | Florida | Recruiting |
| Life Clinical Trials - Coral Springs /ID# 267195 | Coral Springs | Florida | Recruiting |
| Revival Research - Doral /ID# 263541 | Doral | Florida | Completed |
| FXM Clinical Research Ft. Lauderdale /ID# 280911 | Fort Lauderdale | Florida | Recruiting |
| Skin Care Research - Hollywood /ID# 263739 | Hollywood | Florida | Recruiting |
| Solutions Through Advanced Research /ID# 263392 | Jacksonville | Florida | Completed |
| GSI Clinical Research, LLC /ID# 263760 | Margate | Florida | Recruiting |
| Research Associates of South Florida /ID# 267291 | Miami | Florida | Recruiting |
| International Dermatology Research /ID# 264961 | Miami | Florida | Recruiting |
| FAX Pharma Clinical Research /ID# 280915 | Miami | Florida | Recruiting |
| Sullivan Dermatology /ID# 263537 | Miami | Florida | Recruiting |
| Lenus Research and Medical Group /ID# 263779 | Miami | Florida | Recruiting |
| Quality Research of South Florida /ID# 266496 | Miami Lakes | Florida | Completed |
| Fxm Clinical Research - Miramar /ID# 280934 | Miramar | Florida | Recruiting |
| Global Clinical Professionals (GCP) /ID# 266474 | St. Petersburg | Florida | Recruiting |
| Skin Care Research - Tampa /ID# 263750 | Tampa | Florida | Recruiting |
| Alliance Clinical Research of Tampa /ID# 264531 | Tampa | Florida | Recruiting |
| Encore Medical Research - Weston /ID# 278491 | Weston | Florida | Recruiting |
| Centricity Research Columbus Dermatology /ID# 266529 | Columbus | Georgia | Recruiting |
| Cleaver Medical Group Dermatology /ID# 263788 | Dawsonville | Georgia | Recruiting |
| Georgia Skin & Cancer Clinic /ID# 267199 | Savannah | Georgia | Completed |
| Treasure Valley Medical Research /ID# 263738 | Boise | Idaho | Recruiting |
+ 88 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06389136 on ClinicalTrials.gov ↗ ← All trials in Italy