EoE study: Upadacitinib
Official title A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis
ClinicalTrials.gov ID: NCT07588568
What this study is testing
What is Upadacitinib 30mg?
This is an investigational daily pill being studied to see if it helps treat Eosinophilic Esophagitis (EoE). It is designed to block specific proteins in the body that cause inflammation.
Also referred to as RINVOQ.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding upadacitinib to topical steroids reduces EoE symptoms.
- Who it's for
- You may be able to join if you have Eosinophilic Esophagitis that does not respond well to usual treatments.
- What's involved
- You would take a pill every day for 12 weeks, then keep taking it for another 12 weeks. You will fill out surveys and answer health questions. You will visit the clinic every 4 weeks for check‑ups and tests.
- Time commitment
- The study lasts 24 weeks, with clinic visits every 4 weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- Have active esophageal eosinophilia (peak eosinophil count ≥15 eos/hpf [eosinophils per high power field]) as measured during the screening endoscopy...
- Have active symptoms of esophageal dysfunction attributed to EoE (such as trouble swallowing, heartburn, reflux, vomiting, chest pain, painful...
You likely can't join 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: 6.1.
See the full eligibility criteria
- 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...
- 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...
- 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).
- 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: 6.1. Two or more prior episodes of herpes zoster (shingles), or one or more episodes of disseminated herpes zoster; 6.2.
- 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),
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- Inability to read or understand English.
The study team makes the final eligibility decision.
Where it is enrolling
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chapel Hill, North Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.