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

Dr. Falk Pharma

Status and phase: Enrolling; Phase 3

Conditions: Eosinophilic Esophagitis

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06596252

BUL-8/EEA

2020-001314-37 (EudraCT Number)

2024-515229-26-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 308 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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,
• Existing or intended pregnancy or breast-feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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308 participants in 2 patient groups

Arm A

Experimental group

Description:

Budesonide 2 mg orodispersible tablet once daily

Treatment:

Drug: Budesonide

Arm B

Active Comparator group

Description:

Budesonide 1 mg orodispersible tablet twice daily

Treatment:

Drug: Budesonide