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

February 23, 2023 updated by: EMS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil
        • Recruiting
        • Allergisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed consent;
  • Participants aged 18 years or more;

  • Participants diagnosed with eosinophilic esophagitis, defined as:

    1. Presence of symptoms of esophageal dysfunction intermittently or continuously during previous week to the screening visit;
    2. Eosinophilic esophageal inflammation with ≥ 15 eosinophils/high-power field, in the screening endoscopy;
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
10 mL, oral, twice a day.
Other Names:
  • Florence placebo
Experimental: Florence 30
Drug: Florence 30 μg/mL
10 mL, oral, twice a day.
Other Names:
  • EMS oral suspension
Experimental: Florence 60
Drug: Florence 60 μg/mL
10 mL, oral, twice a day.
Other Names:
  • EMS oral suspension
Experimental: Florence 90
Drug: Florence 90 μg/mL
10 mL, oral, twice a day.
Other Names:
  • EMS oral suspension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2021

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS0718 - FLORENCE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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