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
Source ClinicalTrials.gov