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

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02873468
• Other study ID #: EMS0718 - FLORENCE
• Status: Recruiting
• Phase: Phase 2
• Start date: April 19, 2021
• Est. completion date: November 2025

Study information

• Verified date: February 2023
• Source: EMS
• Contact: Arthur M Kummer, MD
• Phone: +551938879851
• Email: pesquisa.clinica[@]ems.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: November 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• Florence 30 µg/mL
10 mL, oral, twice a day.
• Florence 60 µg/mL
10 mL, oral, twice a day.
• Florence 90 µg/mL
10 mL, oral, twice a day.

Other:
• Placebo
10 mL, oral, twice a day.

Locations

Country	Name	City	State
Brazil	Allergisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence and severity of adverse events recorded during the study.		170 days