Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) (EoE KIDS)
Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) (EoE KIDS)
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 meeting validated histologic criteria.
The Secondary objectives are:
- To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS)
- To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE
- To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation
- To study the effects of dupilumab on the type 2 inflammation gene expression signature
- To evaluate the concentration-time profile of functional dupilumab in serum in this population
- To assess efficacy of long-term (52 weeks) dupilumab treatment
- To assess safety, tolerability, and immunogenicity of long-term (52 weeks) dupilumab treatment
- To evaluate the impact of dupilumab treatment on EoE signs and symptoms
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis
Actual Study Start Date: September 1, 2020
Estimated Primary Completion Date: August 8, 2022
Estimated Study Completion Date: July 31, 2023
Arm:
- Experimental: Part A - High Dose
- Experimental: Part A - Low Dose
- Experimental: Part B - High Dose
- Experimental: Part B - Low Dose
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 90 |
| Actual Study start date | 01 September 2020 |
| Estimated Study Completion Date | 31 July 2023 |