Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis
EOS-2
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
2 other identifiers
interventional
204
1 country
1
Brief Summary
The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2016
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedStudy Start
First participant enrolled
January 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2020
CompletedOctober 7, 2021
October 1, 2021
2.9 years
July 7, 2015
October 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of patients free of treatment failure after 48 weeks of treatment.
48 weeks
Secondary Outcomes (2)
Rate of patients with histological relapse
48 weeks
Rate of patients with clinical relapse
48 weeks
Study Arms (3)
Budesonide 0.5mg orodispersible tablet twice daily
EXPERIMENTALBudesonide 0.5mg orodispersible tablet twice daily
Budesonide 1mg orodispersible tablet twice daily
EXPERIMENTALBudesonide 1mg orodispersible tablet twice daily
Placebo orodispersible tablet twice daily
PLACEBO COMPARATORPlacebo orodispersible tablet twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- Clinical and endoscopic signs 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,
- 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 baseline visit,
- Existing or intended pregnancy or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Digestive Diseases Eppendorf
Hamburg, 20249, Germany
Related Publications (1)
Biedermann L, Schlag C, Straumann A, Lucendo AJ, Miehlke S, Vieth M, Santander C, Ciriza de Los Rios C, Schmocker C, Madisch A, Hruz P, Hayat J, von Arnim U, Bredenoord AJ, Schubert S, Halstead M, Pfurr S, Mueller R, Schoepfer AM, Attwood S; International EOS-2 Study Group. Efficacy and Safety of Budesonide Orodispersible Tablets for Eosinophilic Esophagitis up to 3 Years: An Open-Label Extension Study. Clin Gastroenterol Hepatol. 2025 Nov;23(12):2144-2154.e6. doi: 10.1016/j.cgh.2024.10.034. Epub 2024 Dec 16.
PMID: 39694205DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ralph Mueller, PhD
Dr. Falk Pharma GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2015
First Posted
July 9, 2015
Study Start
January 15, 2016
Primary Completion
November 28, 2018
Study Completion
December 11, 2020
Last Updated
October 7, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share