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Dupilumab in pediatric eosinophilic esophagitis
NCT04394351Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2020
- Primary completion
- Jun 2022
- Countries
- 2
- Sponsor
- Regeneron Pharmaceuticals
- Modality
- Monoclonal Antibodies
- Drugs
- dupilumab
- Conditions
- eosinophilic esophagitis (EoE)
01
Overview
Phase 3, randomised, double-blind trial of dupilumab in eosinophilic esophagitis (EoE) (5 arms), sponsored by Regeneron Pharmaceuticals. Primary endpoint: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils/High Power Field at 16 weeks. Started Sep 2020; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Part A - High Dose
16-week double-blind treatment with high dose dupilumab or placebo
Part A - Low Dose
16-week double-blind treatment with low dose dupilumab or placebo
Part B - High Dose
36-week extended active treatment with high dose dupilumab
Part B - Low Dose
36-week extended active treatment with low dose dupilumab
Part C - High Dose
Up to 108-week open-label extension with high dose dupilumab
03
Who it enrols
Pediatric patients aged 1-11 years with documented eosinophilic esophagitis, body weight 5-60 kg, with baseline endoscopic biopsies showing intraepithelial eosinophilic infiltration, excluding other causes of esophageal eosinophilia, active infections, immunodeficiency, and recent topical corticosteroid use
04
Endpoints
Primary
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils/High Power Field
Secondary
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/High Power Field
Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count
Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System Grade Score
Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System Stage Score
Normalized Enrichment Score for the Relative Change From Baseline in the Type 2 Inflammation Signature
Normalized Enrichment Score for the Relative Change From Baseline in the Eosinophilic Esophagitis Diagnostic Panel
Absolute Change From Baseline in Eosinophilic Esophagitis Endoscopic Reference Total Score
Change From Baseline in the Proportion of Days With 1 or More EoE Signs as Measured by Pediatric EoE Sign/Symptom Questionnaire - Caregiver Version
05
Results
Primary endpoints met
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