Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE

Launched by UNIVERSITY OF COLORADO, DENVER · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two treatments for a condition called Eosinophilic Esophagitis (EoE), which causes inflammation and narrowing of the esophagus, making it hard to swallow. The researchers want to find out if a medication called dupilumab, given as an injection once a week, is more effective than a swallowed medication called fluticasone, which is taken twice daily. They will compare how well each treatment improves the size of the esophagus and reduces inflammation over the course of a year.

To participate, individuals must be between 12 and 25 years old, weigh at least 40 kg, and have a confirmed diagnosis of EoE with certain symptoms, such as having trouble swallowing at least twice a week. Participants will be randomly assigned to receive either dupilumab or fluticasone and will attend eight study visits over 52 weeks, complete questionnaires, and undergo procedures like an endoscopy to check their esophagus. This trial is currently recruiting participants, and those interested should discuss eligibility with their healthcare provider.

Gender

ALL

Eligibility 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.