Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.

Official Title
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Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: low dose budesonide tablet
* Drug: high dose budesonide tablet
* Drug: high dose budesonide suspension
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: Signed informed consent Male or female patients, 18 to 75 years of age Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria: (A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf) - Active symptomatic and histological EoE at baseline Major Exclusion Criteria: Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia Other clinical 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) Any relevant systemic disease (e.g., AIDS, active tuberculosis) Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension Abnormal renal function at screening History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma) History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit Upper gastrointestinal bleeding within 8 weeks prior to screening visit Concomitant, or within the 4 weeks prior to screening visit, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants Concomitant, or within the 2 weeks prior to screening visit, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate Installation of dietary restrictions within 4 weeks prior to screening visit or during treatment Intake of grapefruit containing food or beverages during the treatment with study medication Known intolerance/hypersensitivity to study drug Existing or intended pregnancy or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose budesonide tablet<br> | Drug: low dose budesonide tablet<br>* 1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily<br>* Other names: BET 1mg BID;|
| Experimental: High dose budesonide tablet<br> | Drug: high dose budesonide tablet<br>* 2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily<br>* Other names: BET 2mg BID;|
| Experimental: High dose budesonide suspension<br> | Drug: high dose budesonide suspension<br>* placebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily<br>* Other names: BVS 2mg BID;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo tablet twice daily AND 5ml placebo suspension twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of histological remission |  | 2 weeks (LOCF) | 
| Change in the mean numbers of eos |  | 2 weeks (LOCF) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean numbers of eos |  | 2 weeks (LOCF) |