Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515229-26-00

Acronym

BUL-8/EEA

Enrollment

234

Registered

2024-08-19

Start date

2021-05-21

Completion date

Unknown

Last updated

2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

eosinophilic esophagitis

Brief summary

Proportion of patients with histological remission

Detailed description

Change in the peak eos/mm2 hpf from baseline to week 6 (LOCF), Change in the severity of dysphagia, Change in the severity of odynophagia, Change of overall severity of EoE symptoms, Change in the total weekly Eosinophilic Esophagitis Activity Index

Interventions

DRUGJorveza 1 mg orodispersible tablets

DRUGOrodispersible tablet

DRUGBUL03

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with histological remission	—

Secondary

Measure	Time frame
Change in the peak eos/mm2 hpf from baseline to week 6 (LOCF), Change in the severity of dysphagia, Change in the severity of odynophagia, Change of overall severity of EoE symptoms, Change in the total weekly Eosinophilic Esophagitis Activity Index	—

Countries

Austria, Germany, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026