CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 219 enrolled
Drug / intervention
Oral Budesonide Suspension (OBS) +1 moredrug
Likely dose
Oral Budesonide Suspension (OBS) 2mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02736409
NCT02736409Phase 3Completed
CompareCT.gov

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)

Shire·interventional·Posted Apr 13, 2016·Updated Feb 19, 2025

In Brief

A Phase 3 clinical trial evaluating Oral Budesonide Suspension (OBS) and Placebo for Eosinophilic Esophagitis (EoE). Completed, enrolled 219 participants across 62 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Esophagitis (EoE)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 13, 2016
Enrollment StartApr 1, 2016
Primary CompletionNov 12, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.2 years ago

Interventions

Oral Budesonide Suspension (OBS)drug

OBS 2mg twice daily

Placebodrug

Matching Placebo dose