NCT02736409

An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)

A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 11 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire (DSQ) score.

Conditions

• Eosinophilic Esophagitis (EoE)

Interventions

Type	Name	Description
DRUG	Oral Budesonide Suspension (OBS)	OBS 2mg twice daily
DRUG	Placebo	Matching Placebo dose

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-11-12
• Completion: 2019-11-12
• First posted: 2016-04-13
• Last updated: 2025-02-19
• Results posted: 2021-01-13

Locations

62 sites across 1 country: United States