FX-322 in Adults With Acquired Sensorineural Hearing Loss
Primary Purpose
Hearing Loss, Sensorineural, Noise Induced Hearing Loss, Sudden Hearing Loss
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FX-322
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Intratympanic administration, Restoration of hearing loss
Eligibility Criteria
Inclusion Criteria:
- Subject has read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
- Adult aged 18-65 years inclusive at Screening.
- Documented medical history consistent with acquired, adult onset, sensorineural hearing loss associated with noise-induced SNHL (NIHL) or idiopathic sudden SNHL (SSNHL) (documented audiogram at least 6 months prior to screening required).
- A pure tone average at the Screening Visit of 35-85 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
- Ability to communicate well with the Investigator and is willing to comply with and complete all the study procedures.
- Female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception and condom or an intrauterine device and condom) or remain abstinent. Male subjects should use condoms with spermicide during the course of the study or remain abstinent. Subjects should not donate sperm or ova during the study period.
- Have met additional masked criteria as determined by the Electronic Data Capture system.
Exclusion Criteria:
- Subject has previously been randomized in a FX-322 clinical trial.
- Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in study ear. This includes a current tympanostomy tube.
- Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10dB at two or more contiguous octave frequencies in the study ear at the Screening visit.
- Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
- Subject has had an intratympanic injection in either ear within 3 months of the screening visit.
- Evidence of or previous diagnosis of auditory neuropathy, traumatic brain injury, "central" hearing loss, or genetic hearing loss.
- History of chronic, recurrent clinically significant vestibular symptoms.
- History of bilateral sudden sensorineural hearing loss or recurrent sudden sensorineural hearing loss.
- History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
- History of head or neck radiation, treatment, or exposure to platinum based chemotherapy drugs or aminoglycosides.
- Exposure to another investigational drug within 28 days prior to screening visit.
- Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator following a detailed medical history, physical examination, and vital signs (systolic and diastolic blood pressure, pulse rate, body temperature).
- Positive urine pregnancy test or breast-feeding.
- Any known factor, condition, or disease that, in the view of the Investigator, might interfere with treatment compliance, study conduct or interpretation of the results.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
FX-322
Placebo
Arm Description
FX-322, 1 dose
Placebo, 1 dose
Outcomes
Primary Outcome Measures
Word Recognition in Quiet
Percent of subjects exceeding the Carney-Schlauch 95% confidence interval for improvement from baseline in number of words recognized from Consonant-Nucleus-Consonant (CNC) word lists
Secondary Outcome Measures
Words-in-Noise
Mean absolute percent change in number of recognized words from CNC word lists
Standard Pure Tone Audiometry
Mean overall pure tone average (PTA) hearing thresholds in decibels (dB) derived by averaging the air conduction thresholds at 0.5, 1, 2 and 4 kHZ frequencies
Patient Global Impression of Change (PGI-C) Hearing Loss Scale
Average response in PGI-C hearing loss scale, using the assigned numeric values of 1-5: 1) much better, 2) a little better, 3) no change, 4) a little worse 5) much worse
Patient Global Impression of Change (PGI-C) Daily Impacts Scale
Average response in PGI-C daily impacts scale, using the assigned numeric values of 1-5: 1) much better, 2) a little better, 3) no change, 4) a little worse 5) much worse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05086276
Brief Title
FX-322 in Adults With Acquired Sensorineural Hearing Loss
Official Title
A Phase 2, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Multicenter Study to Evaluate the Efficacy of FX-322 Administered by Intratympanic Injection in Adults With Acquired Sensorineural Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Frequency Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).
Detailed Description
This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).
Previous human studies in subjects 18 to 65 years inclusive (FX-322-103, FX-322-201, FX-322-111) and subjects 66-85 inclusive (FX-322-112) demonstrated that a single dose FX-322 was well tolerated in patients with acquired SNHL with no treatment-related serious adverse events. Adverse events in these studies were generally common to and associated with the intratympanic injection procedure with mild and transient discomfort in patients both with the drug and the placebo.
Frequency Therapeutics' Investigators intend to evaluate efficacy with a single dose of FX-322 in subjects 18 to 65 years inclusive with acquired SNHL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Noise Induced Hearing Loss, Sudden Hearing Loss
Keywords
Intratympanic administration, Restoration of hearing loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FX-322
Arm Type
Active Comparator
Arm Description
FX-322, 1 dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 1 dose
Intervention Type
Drug
Intervention Name(s)
FX-322
Intervention Description
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Word Recognition in Quiet
Description
Percent of subjects exceeding the Carney-Schlauch 95% confidence interval for improvement from baseline in number of words recognized from Consonant-Nucleus-Consonant (CNC) word lists
Time Frame
Baseline through Day 90
Secondary Outcome Measure Information:
Title
Words-in-Noise
Description
Mean absolute percent change in number of recognized words from CNC word lists
Time Frame
Baseline through Day 90
Title
Standard Pure Tone Audiometry
Description
Mean overall pure tone average (PTA) hearing thresholds in decibels (dB) derived by averaging the air conduction thresholds at 0.5, 1, 2 and 4 kHZ frequencies
Time Frame
Baseline through Day 90
Title
Patient Global Impression of Change (PGI-C) Hearing Loss Scale
Description
Average response in PGI-C hearing loss scale, using the assigned numeric values of 1-5: 1) much better, 2) a little better, 3) no change, 4) a little worse 5) much worse
Time Frame
Day 90
Title
Patient Global Impression of Change (PGI-C) Daily Impacts Scale
Description
Average response in PGI-C daily impacts scale, using the assigned numeric values of 1-5: 1) much better, 2) a little better, 3) no change, 4) a little worse 5) much worse
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
Adult aged 18-65 years inclusive at Screening.
Documented medical history consistent with acquired, adult onset, sensorineural hearing loss associated with noise-induced SNHL (NIHL) or idiopathic sudden SNHL (SSNHL) (documented audiogram at least 6 months prior to screening required).
A pure tone average at the Screening Visit of 35-85 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
Ability to communicate well with the Investigator and is willing to comply with and complete all the study procedures.
Female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception and condom or an intrauterine device and condom) or remain abstinent. Male subjects should use condoms with spermicide during the course of the study or remain abstinent. Subjects should not donate sperm or ova during the study period.
Have met additional masked criteria as determined by the Electronic Data Capture system.
Exclusion Criteria:
Subject has previously been randomized in a FX-322 clinical trial.
Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in study ear. This includes a current tympanostomy tube.
Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10dB at two or more contiguous octave frequencies in the study ear at the Screening visit.
Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
Subject has had an intratympanic injection in either ear within 3 months of the screening visit.
Evidence of or previous diagnosis of auditory neuropathy, traumatic brain injury, "central" hearing loss, or genetic hearing loss.
History of chronic, recurrent clinically significant vestibular symptoms.
History of bilateral sudden sensorineural hearing loss or recurrent sudden sensorineural hearing loss.
History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
History of head or neck radiation, treatment, or exposure to platinum based chemotherapy drugs or aminoglycosides.
Exposure to another investigational drug within 28 days prior to screening visit.
Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator following a detailed medical history, physical examination, and vital signs (systolic and diastolic blood pressure, pulse rate, body temperature).
Positive urine pregnancy test or breast-feeding.
Any known factor, condition, or disease that, in the view of the Investigator, might interfere with treatment compliance, study conduct or interpretation of the results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl LeBel, PhD
Organizational Affiliation
Frequency Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Fresno
State/Province
California
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Torrance
State/Province
California
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Novi
State/Province
Michigan
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Albany
State/Province
New York
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Amherst
State/Province
New York
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Murray
State/Province
Utah
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
00000
Country
United States
Facility Name
Clinical Trial Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
00000
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FX-322 in Adults With Acquired Sensorineural Hearing Loss
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