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

EMS

Status and phase: Enrolling; Phase 2

Conditions: Eosinophilic Esophagitis

Treatments: Drug: Florence 90 μg/mL; Drug: Florence 60 μg/mL; Other: Placebo; Drug: Florence 30 μg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02873468

EMS0718 - FLORENCE

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 4 patient groups, including a placebo group

Florence 30

Experimental group

Treatment:

Drug: Florence 30 μg/mL

Florence 60

Experimental group

Treatment:

Drug: Florence 60 μg/mL

Florence 90

Experimental group

Treatment:

Drug: Florence 90 μg/mL

Placebo

Placebo Comparator group

Treatment:

Other: Placebo