Comparing dupilumab and topical corticosteroids for treating eosinophilic esophagitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of dupilumab, administered weekly, against swallowed topical fluticasone, taken twice daily, in treating eosinophilic esophagitis (EoE) in patients aged 12 to 25. Participants will undergo randomization and complete 8 study visits over 52 weeks, which will include questionnaires, endoscopies with biopsies, and measurements of esophageal distensibility. The primary goals are to determine which treatment better improves esophageal diameter and reduces inflammation, as well as to assess the feasibility of comparative clinical trials in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Seen at CHCO for clinical care.
* Age 12 - 25 years old inclusive
* Weight ≥40 kg at the time of screening visit
* Confirmed EoE as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy
* Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening.
* Evidence of fibrostenotic features at time of screening endoscopy (grade 2 or 3 esophageal rings, stricture, delayed passage of barium tablet on fluoroscopy, and/or distensibility ≤15mm)

Exclusion Criteria:

* Esophageal dilation performed at index endoscopy
* Patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria.
* Patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria.
* Eligible patients on current STCs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment.
* Patients who have received dupilumab in the past 12 months for any indication are excluded.
* Diet restrictions and PPI use must stay unchanged in the 8 weeks prior to index endoscopy and through the study period.
* Patients with a fasting morning cortisol \<5 within 2 months of screening will not be enrolled. If repeat cortisol levels are normal, patients can be reconsented.
* Known other esophageal disease or esophageal injury (e.g. achalasia, tracheoesophageal fistula, congenital stricture, caustic injury, history of esophageal surgery), inflammatory bowel disease, liver disease, connective tissue disorder, or bleeding disorder.
* Patients with a known gelatin allergy will be excluded from EST collection.

Where it's running

• Children's Hospital Colorado/University of Colorado School of Medicine
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Michelle Landis, BS
• Email: michelle.landis@childrenscolorado.org
• Phone: 720-777-8884

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term assessment of dupilumab for eosinophilic esophagitis in Germany

  This study is testing how well dupilumab works and how safe it is for people aged 12 and older with eosinophilic esophagitis in Germany over two years.

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  This study tests whether IBI3027 can help people with moderate to severe atopic dermatitis as effectively as Dupilumab injections.

  Recruiting Phase 3 Innovent Biologics (Suzhou) Co. Ltd. · Guangzhou, Guangdong · NCT07754786

• Dupilumab in COPD: Real-world Registry of Outcomes

  This registry tests how dupilumab works for COPD patients in everyday care and whether it lowers flare-ups and improves lung function and quality of life.

  Recruiting at 7 sites Sanofi · Indianapolis, Indiana and 6 other locations · NCT07612878

• Upadacitinib for Eosinophilic Esophagitis in adults not responding to standard therapy

  This study tests whether upadacitinib, taken with topical corticosteroids, can reduce disease activity in adults with eosinophilic esophagitis who still have symptoms.

  Recruiting Phase 2 University of North Carolina, Chapel Hill · Chapel Hill, North Carolina and 1 other locations · NCT07588568

• Dupilumab added to standard COPD care after a flare-up

  This study tests whether adding dupilumab to usual COPD care after a severe flare requiring hospitalization can reduce the chance of another flare.

  Recruiting Phase 4 Regeneron Pharmaceuticals · Mullica Hill, New Jersey · NCT07587658

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.