NCT06596252

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	Budesonide	Twice daily intake of the tablet 30 min after a meal

Timeline

• Start date: 2021-05-21
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2024-09-19
• Last updated: 2026-03-11

Locations

26 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study