Dupilumab for Eosinophilic Esophagitis With Severe Strictures (NCT06352073) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Dupilumab for Eosinophilic Esophagitis With Severe Strictures
United States23 participantsStarted 2024-05-16
Plain-language summary
The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab.
Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered in the clinic at the enrollment visit (day 0) and participants (or their caregivers) will receive training on how to self-administer the remaining doses.
Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed.
At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned female at birth (AFAB) may be asked to come to the clinic for a urine pregnancy test.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Requirements to be eligible for the study:
1. Age 16 and older.
2. Diagnosis of EoE (per 2018 AGREE consensus guidelines).
3. Currently active EoE (defined as ≥15 eos/hpf \[eosinophils per high power field\]) based on samples taken from the screening endoscopy.
4. Prior intolerance to or histologic non-response (defined as a peak esophageal eosinophil count of ≥15 eos/hpf) to proton pump inhibitors (PPI) and topical corticosteroids (tCS).
* For PPI, this must be after 8 weeks or more of treatment of at least 40mg daily of any of the approved medications.
* For tCS, this must be after 8 weeks or more of treatment of at least 2mg daily for budesonide or 1760 mcg daily for fluticasone).
5. One of the following specific EoE features:
* A narrow esophagus (previous endoscopy with a severe, \<10mm area of narrowing or where a standard adult endoscope would not fit), OR
* 4 or more prior esophageal dilations (stretching procedures) with at least 2 dilations occurring within one year.
6. Willing to follow certain lifestyle considerations during the study including:
* No diet changes,
* No changes in PPI medication (such as omeprazole \[Prilosec\], esomeprazole \[Nexium\], lansoprazole \[Prevacid\], etc) dose,
* No topical/swallowed (such as flucticasone \[Flovent\], budesonide \[Eohilia\], etc) or systemic steroids (such as prednisone) for add-on EoE therapy,
* Use highly effective birth control methods (for people assigned female at birth who are able to …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.