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A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis

NCT07588568 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-05-15

No results posted yet for this study

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

Conditions

  • EoE
  • Eosinophilic Esophagitis
  • Eosinophilic Esophagitis (EoE)

Interventions

DRUG

Upadacitinib 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.

OTHER

Upadacitinib 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.

Sponsors & Collaborators

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

    collaborator NIH

  • AbbVie

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Evan S Dellon, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-02-28
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07588568 on ClinicalTrials.gov