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

NCT ID: NCT02873468

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2025-11-30

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.

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Florence 30

Group Type: EXPERIMENTAL

Florence 30 μg/mL

Intervention Type: DRUG

10 mL, oral, twice a day.

Florence 60

Group Type: EXPERIMENTAL

Florence 60 μg/mL

Intervention Type: DRUG

10 mL, oral, twice a day.

Florence 90

Group Type: EXPERIMENTAL

Florence 90 μg/mL

Intervention Type: DRUG

10 mL, oral, twice a day.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

10 mL, oral, twice a day.

Interventions

Florence 30 μg/mL

10 mL, oral, twice a day.

Intervention Type: DRUG

Florence 60 μg/mL

10 mL, oral, twice a day.

Intervention Type: DRUG

Florence 90 μg/mL

10 mL, oral, twice a day.

Intervention Type: DRUG

Placebo

10 mL, oral, twice a day.

Intervention Type: OTHER

Other Intervention Names

EMS oral suspension; EMS oral suspension; EMS oral suspension; Florence placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allergisa

Campinas, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Arthur M Kummer, MD

Role: CONTACT

pesquisa.clinica@ems.com.br

+551938879851

Facility Contacts

Marcello I Rabello, MD

Role: primary

Other Identifiers

EMS0718 - FLORENCE

Identifier Type: -

Identifier Source: org_study_id