Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of three doses of Florence oral suspension on changes of eosinophilic infiltration in esophageal biopsies.

Official Title
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Randomized, Double-blind, Multicentric, Parallel, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: Florence 30 μg/mL
* Drug: Florence 60 μg/mL
* Drug: Florence 90 μg/mL
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed consent; Participants aged 18 years or more; Participants diagnosed with eosinophilic esophagitis, defined as: Presence of symptoms of esophageal dysfunction intermittently or continuously during previous week to the screening visit; Eosinophilic esophageal inflammation with ≥ 15 eosinophils/high-power field, in the screening endoscopy; Exclusion of other causes of esophageal eosinophilia. Exclusion Criteria: Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; Participants with a stricture on endoscopy that prevents passage of the endoscope; History of alcohol abuse or drug use; Use of concomitant therapies for any reason that may affect the assessment; History of gastroesophageal surgery; History of the abnormal gastrointestinal disorder; Another disorder that causes esophageal eosinophilia; Pregnancy or risk of pregnancy and lactating patients; Participants with known allergy, contraindication or hypersensitivity to the components of the medicine used in the clinical trial; Participation in clinical trial in the year prior to this study.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Florence 30<br> | Drug: Florence 30 μg/mL<br>* 10 mL, oral, twice a day.<br>* Other names: EMS oral suspension;|
| Experimental: Florence 60<br> | Drug: Florence 60 μg/mL<br>* 10 mL, oral, twice a day.<br>* Other names: EMS oral suspension;|
| Experimental: Florence 90<br> | Drug: Florence 90 μg/mL<br>* 10 mL, oral, twice a day.<br>* Other names: EMS oral suspension;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 10 mL, oral, twice a day.<br>* Other names: Florence placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants presenting a histological response, defined as the presence of ≤ 6 eosinophils/high-power field, at the end of treatment. |  | 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study. |  | 170 days |