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

Primary Purpose

Eosinophilic Esophagitis

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Florence 30 μg/mL
Florence 60 μg/mL
Florence 90 μg/mL
Placebo
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AllergisaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Florence 30

Florence 60

Florence 90

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of participants presenting a histological response, defined as the presence of ≤ 6 eosinophils/high-power field, at the end of treatment.

Secondary Outcome Measures

Incidence and severity of adverse events recorded during the study.

Full Information

First Posted
August 16, 2016
Last Updated
February 23, 2023
Sponsor
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT02873468
Brief Title
Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Florence 30
Arm Type
Experimental
Arm Title
Florence 60
Arm Type
Experimental
Arm Title
Florence 90
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Florence 30 μg/mL
Other Intervention Name(s)
EMS oral suspension
Intervention Description
10 mL, oral, twice a day.
Intervention Type
Drug
Intervention Name(s)
Florence 60 μg/mL
Other Intervention Name(s)
EMS oral suspension
Intervention Description
10 mL, oral, twice a day.
Intervention Type
Drug
Intervention Name(s)
Florence 90 μg/mL
Other Intervention Name(s)
EMS oral suspension
Intervention Description
10 mL, oral, twice a day.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Florence placebo
Intervention Description
10 mL, oral, twice a day.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events recorded during the study.
Time Frame
170 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur M Kummer, MD
Phone
+551938879851
Email
pesquisa.clinica@ems.com.br
Facility Information:
Facility Name
Allergisa
City
Campinas
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcello I Rabello, MD

12. IPD Sharing Statement

Learn more about this trial

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

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