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Compares treatment options for Eosinophilic Esophagitis
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?
Dupilumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for eosinophilic esophagitis.
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
- The goal of this clinical trial is to [primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.] in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question(s) it aims to answer [is/are]: Does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more?
- 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's taking place
- 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 - 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?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.