A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07588568
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib 30mg Dose — DRUG
    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.
  • Upadacitinib Matching Placebo — OTHER
    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.

Study Details

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 Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Feb 28, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib 30mg
    Participants randomly assigned to this arm will receive the active drug for the entire 24 week treatment period. During the first 12 weeks, participants will receive blinded upadacitinib 30mg daily (meaning the participant and study team will not know which medication the participant receives) followed by open-label upadacitinib 30mg daily for 12 weeks.
  • Other: Placebo, followed by Upadacitinib 30mg
    Participants randomly assigned to this arm will receive placebo for 12 weeks, followed by upadacitinib 30mg for 12 weeks. During the first 12 weeks, participants will receive blinded placebo daily (meaning the participant and study team will not know which medication the participant receives) followed by open-label upadacitinib 30mg daily for 12 weeks.

Primary Outcome Measure

Peak eosinophil count (measured in eos/hpf) after 12-weeks of treatment [ Time Frame: At 12-weeks post-treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Hannah Larson
[email protected]
919-966-2996
Julia Phillips
[email protected]
(919) 843-4453
Evan S Dellon, MD, MPH (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Christy Walters
[email protected]
919-668-5499
David Leiman, MD, MSHP (PRINCIPAL_INVESTIGATOR)

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By research site
University of North Carolina at Chapel Hill· Chapel Hill, NCDuke University· Durham, NC

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