Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis

Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001485-99-DE

Enrollment

204

Registered

2015-06-29

Start date

2015-12-08

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 100000004856

Interventions

Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg Pharmaceutical Form: Effervescent tablet INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent, - Male or female patients, 18 to 75 years of age, - Confirmed clinico-pathological diagnosis of EoE according to established diagnostic criteria , - Clinico-pathological remission of EoE - A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia, - Negative pregnancy test in females of childbearing potential at baseline visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 181 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23

Exclusion criteria

Exclusion criteria: - Clinical signs (i.e., acid regurgitation and/or heart burn) and/or endoscopic signs (at least Los Angeles Classification of Esophagitis Grade A) of gastroesophageal reflux disease (GERD), - History of abnormal results in case of an optionally performed pH monitoring of the distal esophagus, - Patients with PPI-responsive esophageal eosinophilia - 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), - 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 (except for non-metastatic cancers, e.g., basalioma), - History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit, - Upper gastrointestinal bleeding within 8 weeks prior to screening visit, - Existing or intended pregnancy or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: Double-blind phase: - To assess the efficacy of a 48-week treatment with 2 x 0.5 mg/d or 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis (EoE). ;Primary end point(s): Rate of patients free of treatment failure after 48 weeks of treatment;Timepoint(s) of evaluation of this end point: after 48 weeks of double-blind phase;Secondary Objective: Double-blind phase: - To study safety and tolerability in the form of adverse events and laboratory parameters - To assess patients’ quality of life. Open-label re-induction phase: - To study re-induction of clinical response in patients with a clinical or histological relapse or having experienced a food impaction which needed endoscopic intervention, Open-label extension phase: - To study maintenance of clinical remission in patients who completed the double-blind phase without a clinical or histological relapse Exploratory: • To study biomarkers in EoE.	—

Measure

Time frame

Main Objective: Double-blind phase: - To assess the efficacy of a 48-week treatment with 2 x 0.5 mg/d or 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis (EoE). ;Primary end point(s): Rate of patients free of treatment failure after 48 weeks of treatment;Timepoint(s) of evaluation of this end point: after 48 weeks of double-blind phase;Secondary Objective: Double-blind phase: - To study safety and tolerability in the form of adverse events and laboratory parameters - To assess patients’ quality of life. Open-label re-induction phase: - To study re-induction of clinical response in patients with a clinical or histological relapse or having experienced a food impaction which needed endoscopic intervention, Open-label extension phase: - To study maintenance of clinical remission in patients who completed the double-blind phase without a clinical or histological relapse Exploratory: • To study biomarkers in EoE.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints: - Rate of patients with histological relapse at week 48 of the double-blind phase - Rate of patients with a clinical relapse, have experienced a food impaction which needed endoscopic intervention, or needed an endoscopic dilation during the DB treatment phase ;Timepoint(s) of evaluation of this end point: after 48 weeks of double-blind phase	—

Countries

Belgium, Denmark, Germany, Netherlands, Spain, Switzerland, United Kingdom

Contacts

Public ContactDept. of Clinic. Res. & Development

Dr. Falk Pharma GmbH

zentrale@drfalkpharma.de+4976115140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026