A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of North Carolina, Chapel Hill
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 groupsSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
AbbVie
Collaborator
University of California, San Diego
Collaborator
La Jolla Institute for Immunology
Collaborator
Duke University
Collaborator
Source ClinicalTrials.gov