Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease (U-EMPOWER)
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Description
The purpose of this study is to assess the efficacy, safety, and how the body interacts with an investigational drug in pediatric patients with Crohn's disease who have not had success with other medications. After study participants are screened, if eligible, they will receive the study drug. The study drug in this study is called Upadacitinib. While Upadacitinib is FDA-approved for use in adults with Crohn's Disease, it is investigational for children with Crohn's Disease.
Eligibility and criteria
What to expect
Study visits will occur at CHOP Philadelphia Main Campus. This study is made up of a main study period (divided into two parts) and what is called a continued access phase. The main study period lasts for about 4.5 years and involves about 28 study visits. Participants may also be eligible for a continued access phase, which allows the participant to continue to use the study drug once the trial is completed. Study procedures include medical record reviews, physical examination, stool sample collection, urine sample collection, potentially having to stop taking some clinically prescribed medications, fasting, pregnancy testing, blood tests, ECG (electrocardiogram), x-rays, and endoscopies, which requires administration of general anesthesia.
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