Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
- Conditions
- Eosinophilic Esophagitis (EoE)
- Registration Number
- NCT04394351
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 102
Key Inclusion Criteria:<br><br> 1. A documented diagnosis of eosinophilic esophagitis (EoE)<br><br> 2. Baseline endoscopic biopsies with a demonstration on central reading of<br> intraepithelial eosinophilic infiltration<br><br>Key Exclusion Criteria:<br><br> 1. Body weight <5 kg or =60 kg at screening<br><br> 2. Other causes of esophageal eosinophilia<br><br> 3. Active Helicobacter pylori<br><br> 4. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal<br> surgery<br><br> 5. Any esophageal stricture unable to be passed with a standard, diagnostic, upper<br> endoscope or any critical esophageal stricture that requires dilation at screening<br><br> 6. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline<br> standard of care endoscopy<br><br> 7. History of bleeding disorders or esophageal varices that, in the opinion of the<br> investigator, would put the patient at undue risk for significant complications from<br> an endoscopy procedure<br><br> 8. Active parasitic infection or suspected parasitic infection<br><br> 9. Known or suspected immunodeficiency disorder<br><br>Key Exclusion for Patients Re-Entering the Study (for Entry into Part C, as defined in<br>protocol):<br><br> 1. Patients who are =12 years old, weigh =40 kg (or minimum weight for which dupilumab<br> is approved for EoE), and dupilumab is commercially available for the treatment of<br> EoE in their country<br><br> 2. Patients who, during their previous participation in this clinical trial, developed<br> an SAE and/or AE deemed related to dupilumab, which in the opinion of the<br> investigator or of the medical monitor could indicate that continued treatment with<br> dupilumab may present an unreasonable risk for the patient<br><br> 3. Patients who did not undergo endoscopy with biopsies at week 16 and/or week 52 or<br> prior to receiving rescue treatment Note: If the endoscopy with biopsies could not<br> occur due to COVID-19 restrictions and rescue treatment was needed to be initiated<br> without delay, these patients will be eligible to participate in Part C<br><br> 4. Patients who became pregnant during their previous participation in this dupilumab<br> clinical trial<br><br> 5. Patients who, during their previous participation in this trial, were prematurely<br> withdrawn because of a protocol violation, poor compliance, or inability to complete<br> required study assessments<br><br>NOTE: Other protocol defined inclusion/exclusion criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of Less Than or Equal to (=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16
- Secondary Outcome Measures
Name Time Method