Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT02873468
Status:
UNKNOWN
Last Update Posted:
2023-02-24
First Post:
2016-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants presenting a histological response, defined as the presence of ≤ 6 eosinophils/high-power field, at the end of treatment.', 'timeFrame': '100 days'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events recorded during the study.', 'timeFrame': '170 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophilic Esophagitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed consent;\n* Participants aged 18 years or more;\n* Participants diagnosed with eosinophilic esophagitis, defined as:\n\n 1. Presence of symptoms of esophageal dysfunction intermittently or continuously during previous week to the screening visit;\n 2. Eosinophilic esophageal inflammation with ≥ 15 eosinophils/high-power field, in the screening endoscopy;\n 3. Exclusion of other causes of esophageal eosinophilia.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* Participants with a stricture on endoscopy that prevents passage of the endoscope;\n* History of alcohol abuse or drug use;\n* Use of concomitant therapies for any reason that may affect the assessment;\n* History of gastroesophageal surgery;\n* History of the abnormal gastrointestinal disorder;\n* Another disorder that causes esophageal eosinophilia;\n* Pregnancy or risk of pregnancy and lactating patients;\n* Participants with known allergy, contraindication or hypersensitivity to the components of the medicine used in the clinical trial;\n* Participation in clinical trial in the year prior to this study.'}, 'identificationModule': {'nctId': 'NCT02873468', 'briefTitle': 'Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EMS0718 - FLORENCE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Florence 30', 'interventionNames': ['Drug: Florence 30 μg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'Florence 60', 'interventionNames': ['Drug: Florence 60 μg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'Florence 90', 'interventionNames': ['Drug: Florence 90 μg/mL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Florence 30 μg/mL', 'type': 'DRUG', 'otherNames': ['EMS oral suspension'], 'description': '10 mL, oral, twice a day.', 'armGroupLabels': ['Florence 30']}, {'name': 'Florence 60 μg/mL', 'type': 'DRUG', 'otherNames': ['EMS oral suspension'], 'description': '10 mL, oral, twice a day.', 'armGroupLabels': ['Florence 60']}, {'name': 'Florence 90 μg/mL', 'type': 'DRUG', 'otherNames': ['EMS oral suspension'], 'description': '10 mL, oral, twice a day.', 'armGroupLabels': ['Florence 90']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Florence placebo'], 'description': '10 mL, oral, twice a day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Campinas', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marcello I Rabello, MD', 'role': 'CONTACT'}], 'facility': 'Allergisa', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'centralContacts': [{'name': 'Arthur M Kummer, MD', 'role': 'CONTACT', 'email': 'pesquisa.clinica@ems.com.br', 'phone': '+551938879851'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}