A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis

Starting soon · Phase 2 · Has a placebo group

Conditions studied: EoE, Eosinophilic Esophagitis, Eosinophilic Esophagitis (EoE)

In brief

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

Key facts

Study ID

NCT07588568

Run by

University of North Carolina, Chapel Hill

People needed

52

Starts

2026-07-01

Expected to finish

2030-06-01

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65 years.
• Diagnosis of EoE per 2018 AGREE consensus guidelines.
• 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.
• Have active esophageal eosinophilia (peak eosinophil count ≥15 eos/hpf [eosinophils per high power field]) as measured during the screening endoscopy despite ongoing therapy with TCS.
• Have active symptoms of esophageal dysfunction attributed to EoE (such as trouble swallowing, heartburn, reflux, vomiting, chest pain, painful swallowing, abdominal pain, malnutrition, etc.) in the 4 weeks prior to the screening endoscopy.
• Willing to continue all current EoE treatments (including medications such as proton pump inhibitors (PPIs), diet elimination, etc.) throughout participation in the study.
• Able to read, comprehend, and sign consent form.
• Ability to take oral medication (swallow a pill) and be willing to adhere to the study regimen (follow dosing instructions and complete study procedures).

You may not qualify if…

• Use of systemic corticosteroids (such as prednisone or methylprednisolone) within 4 weeks of the screening endoscopy.
• Use of dupilumab (dupixent) within 3 months of the screening endoscopy.
• Use of estrogen (including estrogen-containing contraceptives and other hormonal treatments) within 30 days of screening.
• Previous esophageal resection.
• Medical instability making it unsafe to perform an upper endoscopy.
• At the Screening / Baseline or Enrollment Visit, meeting any of the following conditions:
• 1. Two or more prior episodes of herpes zoster (shingles), or one or more episodes of disseminated herpes zoster;
• 2. One or more prior episodes of disseminated herpes simplex (including eczema herpeticum);
• 3. Human immunodeficiency virus (HIV) infection, defined as confirmed positive anti-HIV antibody (HIV Ab) test or a positive HIV Ab/Ag test;
• 4. Active tuberculosis (TB) or latent TB, or meet TB exclusionary parameters;
• 5. Active infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the visit;
• 6. Active diverticulitis within the past 3 months;
• 7. Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study;
• 8. COVID-19 infection: In participants who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the visit of asymptomatic participants. Participants with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics (fever reducers such as ibuprofen, aspirin, and paracetamol) for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Participants may be rescreened if deemed appropriate by the investigator based upon the participant's health status.
• 9. Hepatitis B (HBV) and Hepatitis C (HCV) screening values that meet the following criteria at the most recent testing prior to the first dose of study drug:
• 9.1. HBV: hepatitis B surface antigen (HBs Ag) positive (+) test or detectable HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for participants who are hepatitis B core antibody (HBc Ab) positive (+);
• 9.2. HCV: detectable HCV ribonucleic acid (RNA) in any participant with anti-HCV antibody (HCV Ab).
• At the Screening / Baseline or Enrollment visit, any of the following medical diseases or disorders:
• 1. Prior history of
• cerebrovascular accident (stroke),
• myocardial infarction (heart attack),
• coronary stenting,
• coronary bypass surgery (heart bypass surgery),
• or thrombotic events including deep venous thrombosis (DVT) and pulmonary embolism (PE);
• 2. History of an organ transplant which requires continued immunosuppression;

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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