Eosinophilic EsophagitisPhase 2NCT02873468
Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
A Phase 2 study testing Florence 30 μg/mL, Florence 60 μg/mL and Florence 90 μg/mL in people with Eosinophilic Esophagitis, run by EMS at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Florence 30 μg/mL, Florence 60 μg/mL and Florence 90 μg/mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Apr 2021to Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Allergisa
Campinas, São Paulo
Marcello I Rabello, MD
About this study
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
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
- Being tested
- Florence 30 μg/mL, Florence 60 μg/mL, Florence 90 μg/mL, Placebo
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florence 30 μg/mLDrug
Also called EMS oral suspension
10 mL, oral, twice a day.
Florence 60 μg/mLDrug
Also called EMS oral suspension
10 mL, oral, twice a day.
Florence 90 μg/mLDrug
Also called EMS oral suspension
10 mL, oral, twice a day.
PlaceboOther
Also called Florence placebo
10 mL, oral, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Florence 30 | Experimental | Not described Receives: Drug: Florence 30 μg/mL |
| Florence 60 | Experimental | Not described Receives: Drug: Florence 60 μg/mL |
| Florence 90 | Experimental | Not described Receives: Drug: Florence 90 μg/mL |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants presenting a histological response, defined as the presence of ≤ 6 eosinophils/high-power field, at the end of treatment.
Measured: 100 days
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study.
Measured: 170 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start19 Apr 2021
- Primary completionJul 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873468
- Sponsor's protocol ID
- EMS0718 - FLORENCE
- Status last verified
- Feb 2023
- First submitted
- 16 Aug 2016
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02873468
- Acronym / sponsor ID
- EMS0718 - FLORENCE
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Florence 30 | Experimental | Drug: Florence 30 μg/mL |
| Florence 60 | Experimental | Drug: Florence 60 μg/mL |
| Florence 90 | Experimental | Drug: Florence 90 μg/mL |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed consent;
- Participants aged 18 years or more;
- Participants diagnosed with eosinophilic esophagitis, defined as:
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Florence 30 μg/mLAlso: EMS oral suspension10 mL, oral, twice a day. | Drug | Florence 30 |
| Florence 60 μg/mLAlso: EMS oral suspension10 mL, oral, twice a day. | Drug | Florence 60 |
| Florence 90 μg/mLAlso: EMS oral suspension10 mL, oral, twice a day. | Drug | Florence 90 |
| PlaceboAlso: Florence placebo10 mL, oral, twice a day. | Other | Placebo |
Primary outcome
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
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 170 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Florence 30 μg/mL, Florence 60 μg/mL and Florence 90 μg/mL in people with Eosinophilic Esophagitis, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur M Kummer, MD (+551938879851, pesquisa.clinica@ems.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.