FX-322 in Adults With Acquired Sensorineural Hearing Loss
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
1 other identifier
interventional
142
1 country
26
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2021
CompletedStudy Start
First participant enrolled
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedResults Posted
Study results publicly available
April 21, 2023
CompletedApril 21, 2023
April 1, 2023
1.2 years
October 8, 2021
March 30, 2023
April 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline through Day 90
Secondary Outcomes (4)
Words-in-Noise
Baseline through Day 90
Standard Pure Tone Audiometry
Baseline through Day 90
Patient Global Impression of Change (PGI-C) Hearing Loss Scale
Day 90
Patient Global Impression of Change (PGI-C) Daily Impacts Scale
Day 90
Study Arms (2)
FX-322
ACTIVE COMPARATORFX-322, 1 dose
Placebo
PLACEBO COMPARATORPlacebo, 1 dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Clinical Trial Site
Tucson, Arizona, 00000, United States
Clinical Trial Site
Fresno, California, 00000, United States
Clinical Trial Site
Torrance, California, 00000, United States
Clinical Trial Site
Colorado Springs, Colorado, 00000, United States
Clinical Trial Site
Sarasota, Florida, 00000, United States
Clinical Trial Site
Tampa, Florida, 00000, United States
Clinical Trial Site
Marrero, Louisiana, 00000, United States
Clinical Trial Site
Novi, Michigan, 00000, United States
Clinical Trial Site
Omaha, Nebraska, 00000, United States
Clinical Trial Site
Albany, New York, 00000, United States
Clinical Trial Site
Amherst, New York, 00000, United States
Clinical Trial Site
New York, New York, 00000, United States
Clinical Trial Site
Winston-Salem, North Carolina, 00000, United States
Clinical Trial Site
Cincinnati, Ohio, 00000, United States
Clinical Trial Site
Oklahoma City, Oklahoma, 00000, United States
Clinical Trial Site
Charleston, South Carolina, 00000, United States
Clinical Trial Site
Orangeburg, South Carolina, 00000, United States
Clinical Trial Site
Spartanburg, South Carolina, 00000, United States
Clinical Trial Site
Dallas, Texas, 00000, United States
Clinical Trial Site
Fort Worth, Texas, 00000, United States
Clinical Trial Site
San Antonio, Texas, 00000, United States
Clinical Trial Site
Murray, Utah, 00000, United States
Clinical Trial Site
St. George, Utah, 00000, United States
Clinical Trial Site
Norfolk, Virginia, 00000, United States
Clinical Trial Site
Richmond, Virginia, 00000, United States
Clinical Trial Site
Milwaukee, Wisconsin, 00000, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Frequency Therapeutics
Study Officials
- STUDY DIRECTOR
Carl LeBel, PhD
Frequency Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2021
First Posted
October 20, 2021
Study Start
October 12, 2021
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
April 21, 2023
Results First Posted
April 21, 2023
Record last verified: 2023-04