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

April 22, 2026 updated by: Dr. Falk Pharma GmbH

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

308

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Tomelloso, Spain, 13700
        • Recruiting
        • Department of Gastroenterology, Hospital General de Tomelloso
        • Contact:
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Not yet recruiting
        • Dr. Falk Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Dr. Falk Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 858-824-4151
      • Lomita, California, United States, 90717
        • Withdrawn
        • Dr. Falk Investigational Site
      • San Diego, California, United States, 92193
        • Not yet recruiting
        • Dr. Falk Investigational Site
    • Florida
      • Doral, Florida, United States, 83706
        • Recruiting
        • Dr. Falk Investigational Site
      • New Port Richey, Florida, United States, 34653
        • Recruiting
        • Dr. Falk Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 208-813-6505
    • Louisiana
      • Houma, Louisiana, United States, 70363
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 985-219-6501
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 504-934-8424
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 617-804-6767
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • Wyoming
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • Dr. Falk Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 507-284-2511
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 504-934-8424
      • Jackson, New Jersey, United States, 08527
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 732-724-2500
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Dr. Falk Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7080
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 919-966-2996
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 216-444-7691
      • Mentor, Ohio, United States, 44060
        • Not yet recruiting
        • Dr. Falk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Wyoming
    • Texas
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 956-377-4371
    • Utah
      • Salt Lake City, Utah, United States, 85259
        • Recruiting
        • Dr. Falk Investigational Site
        • Contact:
          • Phone Number: 480-301-6292
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Not yet recruiting
        • Dr. Falk Investigational Site
      • Lynchburg, Virginia, United States, 24502
        • Not yet recruiting
        • Dr. Falk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 weeks
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
Time Frame: 6 weeks
Assessment of clinical scores assessed with questionnaires at the end of treatment visit
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Study Director: Alfredo J Lucendo, MD, PhD, Department of Gastroenterology, Hospital General de Tomelloso, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

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)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eosinophilic Esophagitis

Clinical Trials on Budesonide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe