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Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

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

NCT06596252•Dr. Falk Pharma GmbH

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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,
+1 more criteria

Locations (26)

Dr. Falk Investigational Site

Scottsdale, Arizona, United States

Dr. Falk Investigational Site

Little Rock, Arkansas, United States

Dr. Falk Investigational Site

La Jolla, California, United States

Dr. Falk Investigational Site

Lomita, California, United States

Dr. Falk Investigational Site

San Diego, California, United States

Dr. Falk Investigational Site

Doral, Florida, United States

Dr. Falk Investigational Site

New Port Richey, Florida, United States

Dr. Falk Investigational Site

Boise, Idaho, United States

Dr. Falk Investigational Site

Houma, Louisiana, United States

Dr. Falk Investigational Site

Marrero, Louisiana, United States

Key Dates

Start Date

May 21, 2021

Primary Completion Date

December 1, 2026

Completion Date

March 1, 2027

Last Updated

March 11, 2026

Enrollment

308

ESTIMATED participants

Conditions

Eosinophilic Esophagitis

Interventions

Budesonide

DRUG

Contacts

Sarah Burrack, Dr.

CONTACT

004976115140 zentrale@drfalkpharma.de

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

NCT06693531

Eosinophilic Esophagitis (EoE)

View study

RECRUITING

Eosinophilic Gastrointestinal Disorders Registry

NCT05199532

Eosinophilic EsophagitisEosinophilic Gastroenteritis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Inclusion Criteria

Exclusion Criteria

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Eosinophilic Gastrointestinal Disorders Registry

Prospective Registry of EoSinophilic esOphagitis

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