Comparing dupilumab and topical corticosteroids for treating eosinophilic esophagitis
DeTECTS: Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
This study is testing whether a new weekly injection called dupilumab works better than a daily swallowed medication for treating eosinophilic esophagitis in young people aged 12 to 25.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 12 Years to 25 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | dupilumab |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06705387 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12 to 25 with a confirmed diagnosis of eosinophilic esophagitis and specific symptoms of dysphagia.
Not a fit: Patients who have undergone esophageal dilation or are experiencing acute food impaction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from eosinophilic esophagitis.
How similar studies have performed: Other studies have explored treatments for eosinophilic esophagitis, but this specific comparison of dupilumab and fluticasone is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.