Upadacitinib for Non-responsive Eosinophilic Esophagitis
This study is testing if a medication called upadacitinib can help people with Eosinophilic Esophagitis (EoE), a condition where a type of white blood cell called eosinophils build up in the esophagus. The main goal is to see if adding upadacitinib to your current topical corticosteroid treatment reduces EoE activity. You would take upadacitinib or a placebo (a pill with no medicine) daily for 12 weeks, followed by 12 weeks where everyone receives upadacitinib. You'll also complete surveys and have regular check-ups and tests at the clinic every four weeks. This study is looking for participants aged 18 to 65 who have been diagnosed with EoE and are currently using topical corticosteroids.
- Study design
- This is an interventional study with a planned enrollment of 52 participants. It involves a 12-week blinded period where you might receive upadacitinib or a placebo, followed by a 12-week open-label period where all participants receive upadacitinib.
- What's involved
- You will take daily medication for 24 weeks, visit the clinic every 4 weeks for checkups and tests, and complete surveys. You will also have an upper endoscopy after each 12-week period.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have a final checkup 30 days after your last endoscopy.
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A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Evan S Dellon, MD, MPH · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Peak eosinophil count (measured in eos/hpf) after 12-weeks of treatmentAt 12-weeks post-treatment
Peak eosinophil count (number of eosinophils per high power field (eos/hpf)) will be measured at 12-weeks post-treatment via esophageal biopsy during the study endoscopy. Eosinophil counts will be determined centrally by the study pathologist using a validated protocol.