Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT05061758
Status:
WITHDRAWN
Last Update Posted:
2022-08-25
First Post:
2021-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of LY3056480 in Patients With SNLH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double blinded, randomized, placebo controlled, multi center efficacy phase 2 study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study put on hold', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the efficacy of local treatment with LY3056480 in terms of hearing function', 'timeFrame': '6 months', 'description': '• Number of drug responders with at least a 2dB improvement in an adaptive sentence in noise test (international matrix test) compared to placebo'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sensorineural Hearing Loss']}, 'descriptionModule': {'briefSummary': 'A phase 2 trial with LY3056480 in patients with stable SNHL', 'detailedDescription': 'VESTA is a double blinded, randomized, placebo controlled, multi center efficacy phase 2 study comparing three dosing regimens of 250 µg LY3056480. Adult volunteers with stable mild to moderately-severe SNHL will be recruited through Adult Otolaryngology - Head \\& Neck Surgery Services in the US. Four injections of 250µg LY3056480 or placebo administered trans-tympanically into one ear (worse hearing ear).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female between 18 - 65 years of age;\n2. Minimum of six months of documented stable hearing loss (+/- 5dB);\n3. A documented stable word recognition test (stable for \\~ 6 months +/- 6%/3 words)\n\nExclusion Criteria:\n\n1. Presenting with a primary complaint of tinnitus\n2. Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear\n3. History of suspected or diagnosed genetic cause of hearing loss;\n4. Partial deafness as defined as hearing loss in any frequency (up to 8 kHz) greater than 80dB\n5. Suspected or known diagnosis of the following inner ear pathology, congenital hearing loss, fluctuating hearing loss, Ménière's disease, or secondary endolymphatic hydrops, perilymph fistula, cochlear barotrauma, autoimmune hearing loss, radiation-induced hearing loss, retro-cochlear lesion, ototoxicity\n6. Evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery (except for ear tubes as a child)\n7. Any therapy known as ototoxic\n8. Participant in a previous trial of LY3056480"}, 'identificationModule': {'nctId': 'NCT05061758', 'acronym': 'VESTA', 'briefTitle': 'A Trial of LY3056480 in Patients With SNLH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Audion Therapeutics BV'}, 'officialTitle': 'A Phase 2 Double Blind, Randomized, Placebo Controlled Trial inVEstigating the Effect and Safety of Several Dosing Regimens of LY3056480 in Patients With STAble Sensorineural Hearing Loss', 'orgStudyIdInfo': {'id': 'AUT-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Four injections of 250µg LY3056480', 'description': 'The treatment will be given transtympanically over the course of 2-7 weeks, according to dosing regimens below.\n\n* Group 1 - Regimen 1. Day 1, Day 4, Day 8, Day 11\n* Group 2 - Regimen 2. Weekly\n* Group 3 - Regimen 3. Every two weeks', 'interventionNames': ['Drug: LY3056480']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Four injections of placebo', 'description': 'The treatment will be given transtympanically over the course of 2-7 weeks, according to dosing regimens below.\n\n* Group 1 - Regimen 1. Day 1, Day 4, Day 8, Day 11\n* Group 2 - Regimen 2. Weekly\n* Group 3 - Regimen 3. Every two weeks', 'interventionNames': ['Drug: LY3056480']}], 'interventions': [{'name': 'LY3056480', 'type': 'DRUG', 'description': 'LY3056480 is an inhibitor of gamma-secretase', 'armGroupLabels': ['Four injections of 250µg LY3056480', 'Four injections of placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Eastern Virginia Medical School', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Audion Therapeutics BV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}