Condition: Atopic Dermatitis · Sponsor: AbbVie
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement. Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab. There may be higher treatment burden for participants in this tri…
This description comes directly from the study's public registry record.
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| Applied Research Center Of Arkansas /ID# 268547 | Little Rock, Arkansas, United States | Recruiting |
| Stanford University School of Medicine - Palo Alto /ID# 269622 | Palo Alto, California, United States | Recruiting |
| Integrative Skin Science and Research /ID# 265108 | Sacramento, California, United States | Recruiting |
| Clearlyderm Dermatology - West Boca /ID# 266323 | Boca Raton, Florida, United States | Completed |
| Pediatric Skin Research /ID# 266308 | Coral Gables, Florida, United States | Recruiting |
| Neoclinical Research - Hialeah /ID# 269694 | Hialeah, Florida, United States | Completed |
| Cleaver Medical Group Dermatology /ID# 265099 | Dawsonville, Georgia, United States | Completed |
| Aeroallergy Research Laboratory /ID# 267247 | Savannah, Georgia, United States | Recruiting |
| Treasure Valley Medical Research /ID# 266838 | Boise, Idaho, United States | Recruiting |
| Northwestern University Feinberg School of Medicine /ID# 265117 | Chicago, Illinois, United States | Recruiting |
| Sneeze Wheeze & Itch Associates /ID# 267238 | Normal, Illinois, United States | Recruiting |
| Dawes Fretzin, LLC /ID# 265097 | Indianapolis, Indiana, United States | Recruiting |
+ 136 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06461897