Dupilumab for Eosinophilic Esophagitis With Severe Strictures

NCT06352073 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: 23-2625R668-EE-2380
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eosinophilic Esophagitis; EoE

Keywords

EoE; Stricture; dupilumab; Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• Histologic Response to Dupilumab

  Proportion (percentage) of patients with histologic response, defined as \<15 eosinophils per high-power field (eos/hpf), after 24 weeks of dupilumab 300mg weekly.

  24 weeks

Secondary Outcomes (4)

• Change in Minimum Esophageal Caliber

  24 weeks

• Decrease in Number of Dilations

  52 weeks

• Change in Endoscopic Severity

  24 weeks

• Change in Histologic Severity

  24 weeks

Study Arms (1)

Open Label dupilumab

OTHER

Open label dupilumab 300mg injection given subcutaneously weekly, for 52 weeks.

Drug: Dupilumab

Interventions

Dupilumab DRUG

300mg weekly subcutaneous injection

Also known as: Dupilumab Pre-filled Syringe, Dupixent

Open Label dupilumab

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 get pregnant). 7. Weigh at least 40kg (about 89 pounds or more). Reasons a participant could be excluded: 1. Other eosinophilic gastrointestinal (GI) disease including: * Eosinophilic gastritis, * Eosinophilic enteritis, * Eosinophilic colitis, * Hypereosinophilic syndrome. 2. Recent steroid use (systemic or swallowed/topical corticosteroid within 4 weeks prior to the screening endoscopy). 3. Recent use of dupilumab (Dupixent) (within about 5 months of screening) or prior allergic reaction to dupilumab or its components, or dupilumab intolerance. 4. Recent use of other biologic medications (within either 5 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. 5. Prior esophageal resection (surgery to remove the esophagus). 6. 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). 7. 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. 8. Study doctor's determination that it would not be medically safe to complete an EGD. 9. Inability to read or understand English. 10. Currently pregnant or breastfeeding. 11. Currently in screening or eligible for another study of dupilumab (Dupixent).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Regeneron Pharmaceuticals: collaborator
• Sanofi: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Constriction, Pathologic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Evan S Dellon, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 8, 2024
• Study Start: May 16, 2024
• Primary Completion: April 16, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)