A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis (ATUNE)
University of North Carolina, Chapel Hill
Summary
The goal of this study is to find out if a medication called upadacitinib can help treat a condition called Eosinophilic Esophagitis (EoE). The main question it aims to answer are: \- Does upadacitinib in addition to topical corticosteroids help reduce EoE disease activity? Participants will: * Take upadacitinib or placebo every day for 12 weeks, followed by 12 weeks of upadacitinib * Fill out surveys and answer health questions * Visit the clinic every 4 weeks for checkups and tests
Description
The goal of this study is to find out if a medication called upadacitinib can help treat a condition called Eosinophilic Esophagitis (EoE). This study has different parts. In the first part of the study, some people get the real medicine and some people get a "placebo," which is a pill with no medicine in it. These groups are decided by chance. In the second part of the study, everyone gets the real medication. After screening, qualified participants will be randomly assigned to receive either the medicine or placebo and start taking the medicine. Participants will come to the clinic for a vi…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18-65 years. 2. Diagnosis of EoE per 2018 AGREE consensus guidelines. 3. Currently using topical corticosteroids (TCS) for EoE treatment (either swallowed budesonide, ≥2mg total daily dose or swallowed fluticasone, ≥1760 mcg total daily dose) for at least 8 weeks (prior to the screening endoscopy) and willing to remain on the same TCS treatment with no changes to regimen throughout the study. 4. Have active esophageal eosinophilia (peak eosinophil count ≥15 eos/hpf \[eosinophils per high power field\]) as measured during the screening endoscopy despite ongoing thera…
Interventions
- DrugUpadacitinib 30mg Dose
Upadacitinib 30mg oral tablet. Participants randomly assigned to receive upadacitinib will take upadacitinib 30mg daily throughout the study. Participants randomly assigned to receive placebo will receive upadacitinib for 12 weeks after completing the 12 week blinded treatment period.
- OtherUpadacitinib Matching Placebo
Oral tablet matching in size, shape, color, and taste to the study intervention (upadacitinib). Participants randomly assigned to receive placebo will receive upadacitinib matching placebo for 12 weeks, followed by a 12 week open label treatment period where all participants will receive upadacitinib 30mg.
Locations (2)
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- Duke UniversityDurham, North Carolina