Status:
COMPLETED
Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Eosinophilic Esophagitis (EoE)
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
Brief Summary
The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeti...
Detailed Description
This is a 3-part study: * Part A: Double-blind 16-week treatment period * Part B: 36-week extended active treatment period * Part C: Up to108 weeks open-label extension period
Eligibility Criteria
Inclusion
- Key
- A documented diagnosis of eosinophilic esophagitis (EoE)
- Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
- Key
Exclusion
- Body weight \<5 kg or ≥60 kg at screening
- Other causes of esophageal eosinophilia
- Active Helicobacter pylori
- History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
- Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
- Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy
- History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopy procedure
- Active parasitic infection or suspected parasitic infection
- Known or suspected immunodeficiency disorder
- Key Exclusion for Patients Re-Entering the Study (for Entry into Part C, as defined in protocol):
- Patients who are ≥12 years old, weigh ≥40 kg (or minimum weight for which dupilumab is approved for EoE), and dupilumab is commercially available for the treatment of EoE in their country
- Patients who, during their previous participation in this clinical trial, developed an SAE and/or AE deemed related to dupilumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient
- Patients who did not undergo endoscopy with biopsies at week 16 and/or week 52 or prior to receiving rescue treatment Note: If the endoscopy with biopsies could not occur due to COVID-19 restrictions and rescue treatment was needed to be initiated without delay, these patients will be eligible to participate in Part C
- Patients who became pregnant during their previous participation in this dupilumab clinical trial
- Patients who, during their previous participation in this trial, were prematurely withdrawn because of a protocol violation, poor compliance, or inability to complete required study assessments
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2024
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04394351
Start Date
September 1 2020
End Date
May 14 2024
Last Update
October 27 2025
Active Locations (27)
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1
Regeneron Study Site
Phoenix, Arizona, United States, 85016
2
Regeneron Study Site
Little Rock, Arkansas, United States, 72202
3
Regeneron Study Site
Los Angeles, California, United States, 90027
4
Regeneron Study Site
San Francisco, California, United States, 94143