A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis

NCT07588568 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 25-26731R01DK146043-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Eosinophilic Esophagitis; EoE; upadacitinib; rinvoq

Outcome Measures

Primary Outcomes (1)

• Peak eosinophil count (measured in eos/hpf) after 12-weeks of treatment

  Peak eosinophil count (number of eosinophils per high power field (eos/hpf)) will be measured at 12-weeks post-treatment via esophageal biopsy during the study endoscopy. Eosinophil counts will be determined centrally by the study pathologist using a validated protocol.

  At 12-weeks post-treatment

Secondary Outcomes (6)

• Key Secondary Outcome: Post-treatment EoE histologic scoring system (HSS) after 12-weeks of treatment

  At 12-weeks post-treatment

• Post-treatment EoE Endoscopic Reference Score (EREFS) after 12-weeks of treatment

  At 12-weeks post-treatment

• Proportion of participants with histologic response (<15, ≤ 6, and ≤ 1 eos/hpf) after 12-weeks of treatment.

  12-weeks post-treatment

• Mean change in dysphagia as measured by the EoE Symptom Activity Index (EEsAI) from baseline to 12-weeks post-treatment

  From screening/baseline to 12-weeks post-treatment

• Minimum esophageal diameter as measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) after 12-weeks of treatment

  At 12-weeks post-treatment

Study Arms (2)

Upadacitinib 30mg

EXPERIMENTAL

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.

Drug: Upadacitinib 30mg Dose

Placebo, followed by Upadacitinib 30mg

OTHER

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.

Drug: Upadacitinib 30mg Dose; Other: Upadacitinib Matching Placebo

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.

Also known as: RINVOQ, upadacitinib

Placebo, followed by Upadacitinib 30mg; Upadacitinib 30mg

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.

Also known as: Placebo

Placebo, followed by Upadacitinib 30mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have active symptoms of esophageal dysfunction attributed to EoE (such as trouble swallowing, heartburn, reflux, vomiting, chest pain, painful swallowing, abdominal pain, malnutrition, etc.) in the 4 weeks prior to the screening endoscopy.
• Willing to continue all current EoE treatments (including medications such as proton pump inhibitors (PPIs), diet elimination, etc.) throughout participation in the study.
• Able to read, comprehend, and sign consent form.
• Ability to take oral medication (swallow a pill) and be willing to adhere to the study regimen (follow dosing instructions and complete study procedures).

You may not qualify if:

• 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.
• Medical instability making it unsafe to perform an upper endoscopy.
• At the Screening / Baseline or Enrollment Visit, meeting any of the following conditions:
• Two or more prior episodes of herpes zoster (shingles), or one or more episodes of disseminated herpes zoster;
• One or more prior episodes of disseminated herpes simplex (including eczema herpeticum);
• Human immunodeficiency virus (HIV) infection, defined as confirmed positive anti-HIV antibody (HIV Ab) test or a positive HIV Ab/Ag test;
• Active infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the visit;
• Active diverticulitis within the past 3 months;
• Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study;
• COVID-19 infection: In participants who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the visit of asymptomatic participants. Participants with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics (fever reducers such as ibuprofen, aspirin, and paracetamol) for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Participants may be rescreened if deemed appropriate by the investigator based upon the participant's health status.
• Hepatitis B (HBV) and Hepatitis C (HCV) screening values that meet the following criteria at the most recent testing prior to the first dose of study drug:
• HBV: hepatitis B surface antigen (HBs Ag) positive (+) test or detectable HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for participants who are hepatitis B core antibody (HBc Ab) positive (+);

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• AbbVie: collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Evan S Dellon, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Cortright, MA

CONTACT

919-445-4911; lindsay_cortright@med.unc.edu

Susan Moist, MPH

CONTACT

919-918-5900; susan_moist@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina at Chapel Hill (UNC).
• Access Criteria: When data sharing is permitted, a Data Use Agreement (DUA) specifying the uses of such data to be shared must be in place before any data is shared. Requests can be submitted to the UNC Office of Industry Contracting for processing. The Principal Investigator must confirm that the DUA has been fully executed and IRB, IEC, or REB approval has been granted before sharing data. For further information on DUAs, please refer to the Data Use Agreement Guidance: https://osp.unc.edu/contracting/contracting/. Any questions about data sharing may be directed to the sponsor-investigator, Evan Dellon, at evan\ dellon@med.unc.edu.

Locations

US (2)