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FX-322 in Adults With Acquired Sensorineural Hearing Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05086276
Recruitment Status : Completed
First Posted : October 20, 2021
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Frequency Therapeutics

Tracking Information
First Submitted Date  ICMJE October 8, 2021
First Posted Date  ICMJE October 20, 2021
Last Update Posted Date January 31, 2023
Actual Study Start Date  ICMJE October 12, 2021
Actual Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2021)
Speech Perception [ Time Frame: Four Months ]
Assessment of speech perception using word recognition tests by Day 90
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2021)
  • 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)
  • 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)
  • 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.
  • 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.
  • 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.
  • Patient Global Impression of Change (PGI-C) Hearing Loss Scale [ Time Frame: Day 90 ]
    This questionnaire is a patient reported outcome measure.
  • Patient Global Impression of Change (PGI-C) Daily Impacts Scale [ Time Frame: Day 90 ]
    This questionnaire is a patient reported outcome measure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FX-322 in Adults With Acquired Sensorineural Hearing Loss
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hearing Loss, Sensorineural
  • Noise Induced Hearing Loss
  • Sudden Hearing Loss
Intervention  ICMJE
  • Drug: FX-322
    Active Comparator
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: FX-322
    FX-322, 1 dose (N=62)
    Intervention: Drug: FX-322
  • Placebo Comparator: Placebo
    Placebo, 1 dose (N=62)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2022)
142
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2021)
124
Actual Study Completion Date  ICMJE December 30, 2022
Actual Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05086276
Other Study ID Numbers  ICMJE FX-322-208
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Frequency Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Frequency Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carl LeBel, PhD Frequency Therapeutics
PRS Account Frequency Therapeutics
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP