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

Phase 3

Recruiting

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: Budesonide

• Registration Number: NCT06596252
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-21
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-08
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

• Signed informed consent,
• Male or female patients, 18 to 75 years of age,
• Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
• Active symptomatic and histological EoE
• Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion Criteria

• Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
• Achalasia, scleroderma esophagus, or systemic sclerosis,
• Other clinically evident causes than EoE for esophageal eosinophilia,
• Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection [candida esophagitis]),
• Any relevant systemic disease (e.g., AIDS, active tuberculosis, hepatitis B or C),
• If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
• Liver cirrhosis or portal hypertension,
• History of cancer in the last five years,
• History of esophageal surgery at any time or of esophageal dilation procedures within the last 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture
• Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,
• Existing or intended pregnancy or breast-feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Budesonide	Budesonide 2 mg orodispersible tablet once daily
Arm B	Budesonide	Budesonide 1 mg orodispersible tablet twice daily

Primary Outcome Measures

Name	Time	Method
Proportion of patients in histological remission	6 weeks	Histological assessment of biopsies taken at end of treatment visit

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in clinical remission	6 weeks	Assessment of clinical scores assessed with questionnaires at the end of treatment visit

Trial Locations

Locations (2)

Dr. Falk Investigational Site; 🇺🇸 Harlingen, Texas, United States

Department of Gastroenterology, Hospital General de Tomelloso; 🇪🇸 Tomelloso, Spain