Health Trials

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Upadacitinib 30mg Dose
  • Upadacitinib Matching Placebo

Treatment groups

52 Participants
are divided into 2 treatment groups

Locations

2
University of North Carolina at Chapel Hill27599, Chapel HillNorth Carolina, United States
Duke University27710, DurhamNorth Carolina, United States

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

AbbVie

Collaborator

Source ClinicalTrials.gov