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EoEPhase 2ATUNENCT07588568

A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis

A Phase 2 study testing Upadacitinib 30mg Dose in people with EoE and Eosinophilic Esophagitis, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Upadacitinib 30mg Dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
2 sitesUnited States
Study dates
30 Sep 2026to Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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:
Show all 52Show fewer
  • 6.1. Two or more prior episodes of herpes zoster (shingles), or one or more episodes of disseminated herpes zoster;
  • 6.2. One or more prior episodes of disseminated herpes simplex (including eczema herpeticum);
  • 6.3. Human immunodeficiency virus (HIV) infection, defined as confirmed positive anti-HIV antibody (HIV Ab) test or a positive HIV Ab/Ag test;
  • 6.4. Active tuberculosis (TB) or latent TB, or meet TB exclusionary parameters;
  • 6.5. 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;
  • 6.6. Active diverticulitis within the past 3 months;
  • 6.7. 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;
  • 6.8. 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.
  • 6.9. 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:
  • 6.9.1. 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 (+);
  • 6.9.2. HCV: detectable HCV ribonucleic acid (RNA) in any participant with anti-HCV antibody (HCV Ab).
  • At the Screening / Baseline or Enrollment visit, any of the following medical diseases or disorders:
  • 7.1. Prior history of
  • cerebrovascular accident (stroke),
  • myocardial infarction (heart attack),
  • coronary stenting,
  • coronary bypass surgery (heart bypass surgery),
  • or thrombotic events including deep venous thrombosis (DVT) and pulmonary embolism (PE);
  • 7.2. History of an organ transplant which requires continued immunosuppression;
  • 7.3. History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;
  • 7.4. History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;
  • 7.5. Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; participants with a history of gastric banding/segmentation (such as Lap Band or Realize Band) are not excluded;
  • 7.6. History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;
  • 7.7. Current uncontrolled hypertension defined as a confirmed systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg;
  • 7.8. Known inherited or acquired conditions that predispose to hypercoagulability;
  • 7.9. Current or past smokers;
  • 7.10. In patients 50 years of age and older:
  • High-density lipoprotein (HDL) cholesterol level of <40mg per deciliter,
  • Diabetes mellitus,
  • Family history of premature coronary heart disease,
  • Extraarticular rheumatoid arthritis.
  • 7.11. Severe hepatic impairment (i.e., Child Pugh C cirrhosis).
  • Participants of child-bearing potential who do not meet the following:
  • 8.1. Participants must not have a positive serum pregnancy test (blood test) at the Screening Visit and must have a negative urine pregnancy test at the Enrollment visit prior to the first dose of study drug.
  • 8.2. Participants with an abnormal or inconclusive serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result.
  • 8.3. Participants with a urine pregnancy test at the Enrollment visit that is borderline or ambiguous must have a serum pregnancy test performed. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • 8.4. Participants of childbearing potential who are not able and/or willing to practice at least 1 protocol-specified method of birth control that is highly effective throughout participation in the study (from Screening through at least 30 days after the last dose of study drug. Use of estrogen-containing contraception is not allowable. Participants of non-childbearing potential do not need to use birth control.
  • Participants who are pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.
  • Participants who received treatment with any investigational drug of chemical or biologic nature within 30 days or five half-lives (whichever is longer) prior to the screening endoscopy or who are currently enrolled in another interventional clinical study.
  • Participants with systemic use of known strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers within 30 days or five half-lives (whichever is longer) of the screening endoscopy through the end of study participation: Herbal therapies and other traditional medicines with unknown effect on CYP3A taken systemically are prohibited within 30 days prior to the screening endoscopy and throughout the study. Herbal therapies and other traditional medicines are defined as any herbal formulation intended to treat or prevent health problems and may include supplements based on which herbs the participant is taking.
  • Participants who have received any live vaccine with replicating potential within 30 days prior to the first dose of study drug or have expected need of vaccination with any live vaccine with replicating potential during study participation including at least 30 days after the last dose of study drug. Live vaccines that are incapable of replicating are permitted.
  • Screening laboratory values that meet the following criteria at the most recent testing prior to the first dose of study drug:
  • 13.1. Serum aspartate transaminase (AST) > 2 × upper limit of normal (ULN); 13.2. Serum alanine transaminase (ALT) > 2 × ULN; 13.3. Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 30 mL/min/1.73 m2; 13.4. Total white blood cell (WBC) count < 2,500/µL; 13.5. Absolute neutrophil count (ANC) < 1,200/µL; 13.6. Platelet count < 100,000/µL; 13.7. Absolute lymphocyte count < 750/µL; 13.8. Hemoglobin < 9 g/dL.
  • Known allergic reaction, significant sensitivity, or intolerance to Janus kinase (JAK) inhibitors or their components
  • History of or current clinically significant medical or psychiatric conditions or any other reason that in the opinion of the Investigator would interfere with the participant's participation in this study, would place the participant at risk by participating in the study or would make the participant an unsuitable candidate to receive study drug.
  • Inability to read or understand English.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lindsay Cortright, MA contact

919-445-4911

lindsay_cortright@med.unc.edu

Susan Moist, MPH contact

919-918-5900

susan_moist@med.unc.edu

United States2 sites, 2 recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Hannah Larson, MPH, 919-966-2996, hannah_larson@med.unc.edu

    Julia Mason, (919) 843-4453, julia_mason@med.unc.edu

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Christy Walters, 919-668-5499, Christy.walters@duke.edu

    David Leiman, MD, MSHP

    Not yet recruiting

Other trials in United States

About this study

Official title: A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis (ATUNE)

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
Read the detailed description

The goal of this study is to find out if a medication called upadacitinib can help treat a condition called Eosinophilic Esophagitis (EoE). This study has different parts. In the first part of the study, some people get the real medicine and some people get a "placebo," which is a pill with no medicine in it. These groups are decided by chance. In the second part of the study, everyone gets the real medication.

After screening, qualified participants will be randomly assigned to receive either the medicine or placebo and start taking the medicine. Participants will come to the clinic for a visit every 4 weeks and have a physical exam, blood tests, answer health questions, and complete surveys.

The first 12-weeks of the study treatment are "blinded," meaning participants and the study team won't know who gets the real medicine and who gets the placebo. The next 12 weeks are "open-label," meaning everyone gets upadacitinib. After each 12-week part, participants will have an upper endoscopy (esophagogastroduodenoscopy; EGD) to check on EoE disease activity.

30 days after the final EGD, participants will have a final checkup.

Being tested
Upadacitinib 30mg Dose, Upadacitinib Matching Placebo
Keywords
Eosinophilic Esophagitis, EoE, upadacitinib, rinvoq
Medical subject headings
Eosinophilic Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upadacitinib 30mg DoseDrug

    Also called RINVOQ, upadacitinib

    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 PlaceboOther

    Also called 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.

Study groups in NCT07588568
Study groupRoleWhat they receive
Upadacitinib 30mgExperimentalParticipants 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.
Receives: Drug: Upadacitinib 30mg Dose
Placebo, followed by Upadacitinib 30mgOtherParticipants 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.
Receives: Drug: Upadacitinib 30mg Dose; Other: Upadacitinib Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 12-weeks post-treatment

Secondary outcomes (6)

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

    The EoE Histologic Scoring System (EoEHSS) score ranges from 0-1, with higher scores indicating greater histologic severity. This study will compare both grade (most severe area) and stage (extent of involvement) parameters of the HSS. EoEHSS will be assessed centrally by the study pathologist.

    Measured: At 12-weeks post-treatment

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

    EREFS ranges from 0-9, with higher scores indicating greater endoscopic severity. EREFS will be assessed during endoscopy by the endoscopist.

    Measured: At 12-weeks post-treatment

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

    Proportion (percentage) of participants who achieve histologic response at each threshold (<15 eosinophils per high power field (eos/hpf), ≤ 6 eos/hpf, and ≤ 1 eos/hpf) after 12-weeks of treatment. All eosinophil counts will be performed centrally by the study pathologist.

    Measured: 12-weeks post-treatment

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

    EEsAI is a validated patient-reported outcome instrument which measures symptoms of dysphagia over a 7-day recall period. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms.

    Measured: From screening/baseline to 12-weeks post-treatment

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

    EndoFLIP measures esophageal compliance and distensibility, and yields a measurement of the minimum esophageal diameter (in mm). This will be performed during endoscopy by the endoscopist.

    Measured: At 12-weeks post-treatment

  6. Esophageal distensibility plateau as measured on EndoFLIP after 12-weeks of treatment

    EndoFLIP measures esophageal compliance and distensibility, and yields a measurement of the minimum esophageal diameter (in mm). This will be performed during endoscopy by the endoscopist.

    Measured: At 12-weeks post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start30 Sep 2026
  3. Primary completionFeb 2030 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07588568
Sponsor's protocol ID
25-2376
Other IDs
1R01DK146043-01
Acronym
ATUNE
Status last verified
Sep 2026
First submitted
6 May 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: This study will adhere to the NIH Grant Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources Principles and Guidelines for Recipients of NIH Grants and Contracts.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Upadacitinib 30mg Dose in people with EoE and Eosinophilic Esophagitis, run by University of North Carolina, Chapel Hill at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lindsay Cortright, MA (919-445-4911, lindsay_cortright@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak eosinophil count (measured in eos/hpf) after 12-weeks of treatment (time frame: At 12-weeks post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07588568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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