drugset / Trial / NCT03633617

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

Phase 3 Completed 321 enrolled Regeneron Pharmaceuticals Sanofi · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objectives of the study by study part are: Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B. Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures. Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures. The secondary objectives of the study are: * To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE * To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses * To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation * To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids

Timeline

Start: 2018-09-24
Primary completion: 2021-09-09
Completion: 2022-06-07

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (superiority test); Part B: Placebo vs Part B: Dupilumab 300 mg SC QW; p <0.0001; Difference in proportion 53.5 (95% CI 41.20 to 65.79) reads as mixed primary results NCT03633617 ↗

registry analysis (superiority test); Part B: Placebo vs Part B: Dupilumab 300 mg SC QW; p <0.0001; LS Mean Difference -9.92 (95% CI -14.811 to -5.022); ANCOVA reads as mixed primary results NCT03633617 ↗

registry analysis (superiority test); Part B: Placebo vs Part B: Dupilumab 300 mg SC Q2W; p = 0.8393; LS Mean Difference -0.51 (95% CI -5.423 to 4.406); ANCOVA reads as mixed primary results NCT03633617 ↗

release “The trial met both of its co-primary endpoints, as well as all key secondary endpoints.” reads as met primary endpoint regeneron.com ↗

release “Part A of the Dupixent EoE pivotal Phase 3 trial met both co-primary endpoints” reads as met primary endpoint regeneron.com ↗

release “pivotal phase 3 trial evaluating Dupixent ® in patients 12 years and older with eosinophilic esophagitis (EoE) met both of its co-primary endpoints” reads as met primary endpoint sanofi.com ↗

release “Part A of the randomized, double-blind, placebo-controlled trial of 81 patients met both of its co-primary endpoints” reads as met primary endpoint sanofi.com ↗

release “Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE) demonstrated that the trial met its co-primary endpoints” reads as met primary endpoint sanofi.com ↗

release “a second Phase 3 trial in adults and adolescents with eosinophilic esophagitis (EoE) met its co-primary endpoints” reads as met primary endpoint regeneron.com ↗

release “second Phase 3 trial that showed Dupixent® (dupilumab) 300 mg weekly significantly improved the signs and symptoms of eosinophilic esophagitis (EoE)” reads as met primary endpoint regeneron.com ↗

release “positive Phase 3 trial showing adults and adolescents treated with Dupixent® (dupilumab) 300 mg weekly experienced significant improvements in signs and symptoms of eosinophilic esophagitis (EoE)” reads as met primary endpoint regeneron.com ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dupilumab	Monoclonal antibody	300 mg	Subcutaneous