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FX-322 in Adults With Acquired Sensorineural Hearing Loss

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ClinicalTrials.gov Identifier: NCT05086276
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Frequency Therapeutics

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).

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Noise Induced Hearing Loss Sudden Hearing Loss Drug: FX-322 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 12, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FX-322
FX-322, 1 dose (N=62)
Drug: FX-322
Active Comparator

Placebo Comparator: Placebo
Placebo, 1 dose (N=62)
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Speech Perception [ Time Frame: Four Months ]
    Assessment of speech perception using word recognition tests by Day 90


Secondary Outcome Measures :
  1. Standard Pure Tone Audiometry [ Time Frame: Four Months ]
    Standard pure tone audiometry will be measured to determine a subject's threshold for hearing at standard frequencies (Hz)

  2. Extended High Frequency Pure Tone Audiometry [ Time Frame: Four Months ]
    Pure tone audiometry will be measured to determine a subject's threshold for hearing at extended high range frequencies (Hz)

  3. Intratympanic Injection Qualitative Questionnaire [ Time Frame: Day 1 ]
    Subjects will select their response to each statement on the questionnaire describing their experiences due to sensorineural hearing loss.

  4. Tinnitus Assessment [ Time Frame: Day 1 and Day 90 ]
    Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 10 that defines severity categories based on 25 self-reported answers.

  5. Research Assessment on Discernment, Intelligibility, Audibility and Quality of Life (RADIAL) Questionnaire [ Time Frame: Day 1 and Day 90 ]
    This questionnaire is a patient reported outcome measure.

  6. Patient Global Impression of Change (PGI-C) Hearing Loss Scale [ Time Frame: Day 90 ]
    This questionnaire is a patient reported outcome measure.

  7. Patient Global Impression of Change (PGI-C) Daily Impacts Scale [ Time Frame: Day 90 ]
    This questionnaire is a patient reported outcome measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
  2. Adult aged 18-65 years inclusive at Screening.
  3. 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).
  4. A pure tone average at the Screening Visit of 35-85 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
  5. Ability to communicate well with the Investigator and is willing to comply with and complete all the study procedures.
  6. 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.
  7. Have met additional masked criteria as determined by the Electronic Data Capture system.

Exclusion Criteria:

  1. Subject has previously been randomized in a FX-322 clinical trial.
  2. 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.
  3. 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.
  4. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
  5. Subject has had an intratympanic injection in either ear within 3 months of the screening visit.
  6. Evidence of or previous diagnosis of auditory neuropathy, traumatic brain injury, "central" hearing loss, or genetic hearing loss.
  7. History of chronic, recurrent clinically significant vestibular symptoms.
  8. History of bilateral sudden sensorineural hearing loss or recurrent sudden sensorineural hearing loss.
  9. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
  10. History of head or neck radiation, treatment, or exposure to platinum based chemotherapy drugs or aminoglycosides.
  11. Exposure to another investigational drug within 28 days prior to screening visit.
  12. 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).
  13. Positive urine pregnancy test or breast-feeding.
  14. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086276


Contacts
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Contact: Clinical Trials Information Desk 800-839-9241 ClinicalTrialsInformation@FrequencyTx.com

Locations
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United States, California
Clinical Trial Site Recruiting
Fresno, California, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, Colorado
Clinical Trial Site Recruiting
Colorado Springs, Colorado, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, Florida
Clinical Trial Site Recruiting
Sarasota, Florida, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
Clinical Trial Site Recruiting
Tampa, Florida, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, Louisiana
Clinical Trial Site Recruiting
Marrero, Louisiana, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, Michigan
Clinical Trial Site Recruiting
Novi, Michigan, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, Nebraska
Clinical Trial Site Recruiting
Omaha, Nebraska, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, New York
Clinical Trial Site Recruiting
Albany, New York, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
Clinical Trial Site Recruiting
Amherst, New York, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
Clinical Trial Site Recruiting
New York, New York, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, North Carolina
Clinical Trial Site Recruiting
Winston-Salem, North Carolina, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, Oklahoma
Clinical Trial Site Recruiting
Oklahoma City, Oklahoma, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, South Carolina
Clinical Trial Site Recruiting
Orangeburg, South Carolina, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, Texas
Clinical Trial Site Recruiting
San Antonio, Texas, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, Utah
Clinical Trial Site Recruiting
Saint George, Utah, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
United States, Virginia
Clinical Trial Site Recruiting
Norfolk, Virginia, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
Clinical Trial Site Recruiting
Richmond, Virginia, United States, 00000
Contact    415-326-8829    hearingstudy@clarahealth.com   
Sponsors and Collaborators
Frequency Therapeutics
Investigators
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Study Director: Carl LeBel, PhD Frequency Therapeutics
Additional Information:
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Responsible Party: Frequency Therapeutics
ClinicalTrials.gov Identifier: NCT05086276    
Other Study ID Numbers: FX-322-208
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frequency Therapeutics:
Intratympanic administration
Restoration of hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Noise-Induced
Hearing Loss, Sudden
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases