Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE (EOS-4)

Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Drug: Budesonide

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Tomelloso, Spain, 13700
    • Department of Gastroenterology, Hospital General de Tomelloso
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Dr. Falk Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Dr. Falk Investigational Site
  • California
    • La Jolla, California, United States, 92037
      • Dr. Falk Investigational Site
    • San Diego, California, United States, 92193
      • Dr. Falk Investigational Site
  • Florida
    • Doral, Florida, United States, 83706
      • Dr. Falk Investigational Site
    • New Port Richey, Florida, United States, 34653
      • Dr. Falk Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83706
      • Dr. Falk Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Dr. Falk Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Wyoming
    • Wyoming, Michigan, United States, 49519
      • Dr. Falk Investigational Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Dr. Falk Investigational Site
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Dr. Falk Investigational Site
  • New York
    • New York, New York, United States, 10075
      • Dr. Falk Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7080
      • Dr. Falk Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Dr. Falk Investigational Site
    • Mentor, Ohio, United States, 44060
      • Dr. Falk Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Wyoming
  • Texas
    • Harlingen, Texas, United States, 78550
      • Dr. Falk Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 85259
      • Dr. Falk Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Dr. Falk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Budesonide 2 mg orodispersible tablet once daily	Drug: Budesonide; Twice daily intake of the tablet 30 min after a meal
Active Comparator: Arm B; Budesonide 1 mg orodispersible tablet twice daily	Drug: Budesonide; Twice daily intake of the tablet 30 min after a meal
Experimental: OLE; Open label extension with Budesonide 0.5 mg or 1 mg orodispersible tablet twice daily	Drug: Budesonide; Twice daily intake of the tablet 30 min after a meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients in histological remission	Histological assessment of biopsies taken at end of treatment visit	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients in clinical remission	Assessment of clinical scores assessed with questionnaires at the end of treatment visit	6 weeks

Collaborators and Investigators

• Sponsor: Dr. Falk Pharma GmbH
• Investigators: Study Director: Alfredo J Lucendo, MD, PhD, Department of Gastroenterology, Hospital General de Tomelloso, Spain

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Budesonide
• Other Study ID Numbers: BUL-8/EEA; 2024-515229-26-00 (Ctis); 2020-001314-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is not yet decided which data will be made available. Neither a time frame can be indicated yet.
• IPD Sharing Time Frame: It is not yet decided which data will be made available. Neither a time frame can be indicated yet.
• IPD Sharing Access Criteria: Contact to Dr. Falk, issue of confidentiality agreement for any information not publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No