Dupilumab treatment for severe Eosinophilic Esophagitis

Dupilumab for Eosinophilic Esophagitis With Severe Strictures (DESTRICT Study)

This study is testing if dupilumab can help people aged 16 and older with severe Eosinophilic Esophagitis feel better by reducing their symptoms over a year of treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (Academic / other)
• Drugs / interventions: dupilumab, mepolizumab, reslizumab, benralizumab, cendakimab, tezepelumab, barzolvolimab
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT06352073 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the effectiveness of dupilumab, an FDA-approved medication, in treating patients with severe strictures caused by Eosinophilic Esophagitis (EoE). Participants aged 16 and older will receive weekly subcutaneous injections of dupilumab for one year, following an initial screening that includes endoscopy and biopsies. The study is open-label, meaning all participants will receive the treatment, and they will attend regular follow-up visits to monitor their health and response to the medication.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 16 and older diagnosed with active EoE and severe strictures who have not responded to or tolerated previous treatments.

Not a fit: Patients who do not have EoE or those who have not experienced severe strictures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from severe EoE by alleviating symptoms and reducing esophageal strictures.

How similar studies have performed: Previous studies have shown positive outcomes with dupilumab in treating EoE, indicating that this approach is supported by existing evidence.

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).

Where this trial is running

Chapel Hill, North Carolina

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Evan S Dellon, MD, MPH — University of North Carolina, Chapel Hill
• Study coordinator: Susan Moist, MPH

Conditions Eosinophilic Esophagitis; EoE; Stricture; dupilumab