Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis

Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003737-29-DE

Enrollment

Registered

2018-12-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-02-19

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

Conditions

Active eosinophilic esophagitis and 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: Budesonide oral suspension [0.2 mg/ml] Pharmaceutical Form: Oral suspension INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg/ml milligram(s)/millilitre Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for DB-treatment phase: • Signed informed consent • Male or female patients, =2 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria for DB treatment phase: • Erosive 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, symptomatic Helicobacter pylori associated gastritis or any planned Helicobacter pylori eradication, oropharyngeal or esophageal bacterial, viral, or untreated or inadequately treated fungal infection [candida esophagitis]) • Any known relevant infectious diseases (e.g., AIDS defining disease, active tuberculosis, hepatitis B, or hepatitis C) • Diabetes mellitus • If careful medical monitoring is not ensured: cardiovascular disease, hypertension, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection • History of cancer in the last five years • History of esophageal surgery at any time or of esophageal dilation procedures within the last 12 weeks prior to screening endoscopy, presence of an acute obstruction and/or need for an immediate endoscopic intervention due to a stricture • In case of treatment equivalence of either steroid, PPI or dietary treatment: Patient/ parents wish to install a new or changed dietary or PPI approach • Patient with high disease burden at screening and/or any patient with need for immediate treatment (incl. due to severe dysphagia, dehydration, loss of weight), • Upper gastrointestinal bleeding within 8 weeks prior to screening endoscopy • Existing or intended pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Double-blind phase: To prove superior efficacy of budesonide oral suspension compared to placebo in children and adolescents with eosinophilic esophagitis (EoE) ;Secondary Objective: Double-blind phase: To further assess efficacy of budesonide oral suspension in children and adolescents with eosinophilic esophagitis (EoE) ;Primary end point(s): Double-blind phase: Rate of patients with pathological remission and clinical response at DB week 12 ;Timepoint(s) of evaluation of this end point: week 12	—

Measure

Time frame

Main Objective: Double-blind phase: To prove superior efficacy of budesonide oral suspension compared to placebo in children and adolescents with eosinophilic esophagitis (EoE) ;Secondary Objective: Double-blind phase: To further assess efficacy of budesonide oral suspension in children and adolescents with eosinophilic esophagitis (EoE) ;Primary end point(s): Double-blind phase: Rate of patients with pathological remission and clinical response at DB week 12 ;Timepoint(s) of evaluation of this end point: week 12

—

Secondary

Measure	Time frame
Secondary end point(s): Double-blind phase: - Rate of patients with histological remission at DB week 12 - Rate of patients with clinical response at DB week 12 ;Timepoint(s) of evaluation of this end point: week 12	—

Countries

Germany, Greece, Israel, Netherlands, Portugal, Spain, United Kingdom

Contacts

Public ContactDept. of Clin. 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