Eosinophilic Esophagitis study: Dupilumab vs Fluticasone
Official title Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
ClinicalTrials.gov ID: NCT06705387
What this study is testing
What is Dupilumab?
An investigational once‑weekly injectable medicine being studied as a potential treatment for eosinophilic esophagitis. Dupilumab is designed to block the IL‑4Rα receptor, reducing signaling of interleukins 4 and 13 that drive inflammation.
Also referred to as Dupixent.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether dupilumab or swallowed fluticasone can make the esophagus wider and reduce inflammation. It also checks if such a comparison study is doable.
- Who it's for
- You may be able to join if you have eosinophilic esophagitis and a narrowed esophagus.
- What's involved
- You will be randomly given either a weekly injection of dupilumab or a twice‑daily swallowed steroid. You will visit the clinic 8 times over a year, fill out questionnaires, and have an endoscopy with tissue samples and special measurements. You will also swallow an esophageal string test.
- Time commitment
- The study lasts one year with eight clinic visits and several tests.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 52 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 25
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility 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)
- 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...
- Patients with a known gelatin allergy will be excluded from EST collection.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.