Dupilumab for Eosinophilic Esophagitis With Severe Strictures

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Apr 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called dupilumab in treating patients with a condition known as eosinophilic esophagitis (EoE), particularly those with severe strictures, or narrowings, in the esophagus. EoE is an allergic condition that affects the esophagus, leading to difficulty swallowing and other symptoms. In this study, all participants will receive dupilumab through injections under the skin once a week for a year. Before starting the treatment, participants will have a screening visit that includes surveys and an endoscopy, which is a procedure to look inside the esophagus.

To be eligible for this trial, participants must be at least 16 years old, have a confirmed diagnosis of EoE, and have had active symptoms despite trying other treatments. Some other key requirements include having a history of severe esophagus narrowing or needing multiple dilations to treat the condition. Throughout the study, participants will have regular check-ins to monitor their health and response to the medication. It's important to note that participants will need to avoid certain medications and lifestyle changes during the study. This trial is currently recruiting participants, and it's a great opportunity for those looking for new treatment options for EoE.

Gender

ALL

Eligibility criteria

• Requirements to be eligible for the study:
• • Age 16 and older.
• • Diagnosis of EoE (per 2018 AGREE consensus guidelines)
• • Currently active EoE (defined as ≥15 eos/hpf \[eosinophils per high power field\]) based on samples taken from the screening endoscopy.
• • 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).
• • One of the following specific EoE features: 1) a narrow esophagus where a standard adult endoscope would not fit or 2) 4 or more prior esophageal dilations (stretching procedures), with at least 2 dilations reported within one year.
• * Willing to follow certain lifestyle considerations during the study including:
• • No diet changes,
• • No changes in PPI medication dose,
• • No topical/swallowed (tCS) or systemic steroids for add-on EoE therapy,
• • Use highly effective birth control methods.
• • Weigh at least 40kg (about 89 pounds or more).
• Reasons a participant could be excluded:
• * Other eosinophilic gastrointestinal (GI) disease including:
• • Eosinophilic gastritis,
• • Eosinophilic enteritis,
• • Eosinophilic colitis,
• • Hypereosinophilic syndrome.
• • Recent steroid use (systemic or swallowed/topical corticosteroid within 4 weeks prior to the screening endoscopy).
• • Recent use of dupilumab (Dupixent) (within 6 months of screening).
• • Prior allergic reaction to dupilumab or its components, or dupilumab intolerance.
• * Recent use of other biologic medications (within either 6 months or 5 half-lives, whichever is longer). Examples of biologic medications include:
• • mepolizumab (Nucala),
• • reslizumab (Cinqair, Cinqaero),
• • benralizumab (Fasenra),
• • cendakimab,
• • tezepelumab (Tezspire),
• • barzolvolimab, etc.
• • Prior esophageal resection (surgery to remove the esophagus).
• • Participants taking blood thinners (such as coumadin, warfarin, heparin, etc.) who are unable to stop taking them for a brief period prior to EGD (as required by normal clinical practice).
• * Recent vaccination with a live (attenuated) vaccine (within 4 weeks of screening). Live vaccines include:
• • Chickenpox (varicella),
• • FluMist and Intranasal influenza,
• • Measles (rubeola),
• • Mumps,
• • Rubella,
• • Oral polio,
• • Oral typhoid,
• • Smallpox (vaccinia),
• • Yellow fever,
• • Bacille Calmette-Guerin
• • Rotavirus
• • Combination vaccines of any of the above.
• • Study doctor's determination that it would not be medically safe to complete an EGD.
• • Inability to read or understand English.
• • Currently pregnant or breastfeeding.
• • Currently in screening or eligible for another study of dupilumab (Dupixent).