Phase
Condition
Esophageal Disorders
Heartburn (Pediatric)
Heartburn
Treatment
Dupilumab
Clinical Study ID
Ages > 16 All Genders
Study Summary
Eligibility Criteria
Inclusion
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).
Study Design
Study Description
Connect with a study center
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
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