Clinical trial NCT06596252: Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Eosinophilic Esophagitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Proportion of patients in histological remission
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of patients in clinical remission
timeFrame: 6 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Dr. Falk Investigational Site
state: California
city: Lomita
country: United States
facility: Dr. Falk Investigational Site
state: California
city: Houma
country: United States
facility: Dr. Falk Investigational Site
state: Louisiana
city: Marrero
country: United States
facility: Dr. Falk Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Dr. Falk Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: Dr. Falk Investigational Site
state: Minnesota
city: Freehold
country: United States
facility: Dr. Falk Investigational Site
state: New Jersey
city: Jackson
country: United States
facility: Dr. Falk Investigational Site
state: New Jersey
city: Chapel Hill
country: United States
facility: Dr. Falk Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Dr. Falk Investigational Site
state: Ohio
city: Harlingen
country: United States
facility: Dr. Falk Investigational Site
state: Texas
city: Tomelloso
country: Spain
facility: Department of Gastroenterology, Hospital General de Tomelloso
Study officials:
affiliation: Department of Gastroenterology, Hospital General de Tomelloso, Spain
name: Alfredo J Lucendo, MD, PhD
role: STUDY_DIRECTOR
References: