drugset / Trial / NCT06596252

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

NCT06596252 ↗

Phase 3 Recruiting 308 enrolled Dr. Falk Pharma GmbH
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2021-05-21
Primary completion
2026-12
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 0.5 mg —
Subject Budesonide Small molecule 1 mg —
Subject Budesonide Small molecule 2 mg —