Back to resultsEfficacy 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
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis
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.
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
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
We'll reach out to this number within 24 hrs