Dupilumab for Eosinophilic Esophagitis With Severe Strictures

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion 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).