Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
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
1 other identifier
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2021
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedStudy Start
First participant enrolled
April 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedFebruary 24, 2023
February 1, 2023
4.2 years
August 16, 2016
February 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence and severity of adverse events recorded during the study.
170 days
Study Arms (4)
Florence 30
EXPERIMENTALFlorence 60
EXPERIMENTALFlorence 90
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMSlead
Study Sites (1)
Allergisa
Campinas, São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 19, 2016
Study Start
April 19, 2021
Primary Completion
July 1, 2025
Study Completion
November 1, 2025
Last Updated
February 24, 2023
Record last verified: 2023-02