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FX-322 in Adults With Acquired Sensorineural Hearing Loss

Sponsor
Frequency Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05086276
Collaborator
(none)
124
Enrollment
26
Locations
2
Arms
12.6
Anticipated Duration (Months)
4.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 12, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Speech Perception [Four Months]

    Assessment of speech perception using word recognition tests by Day 90

Secondary Outcome Measures

  1. Standard Pure Tone Audiometry [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 [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 [Day 1]

    Subjects will select their response to each statement on the questionnaire describing their experiences due to sensorineural hearing loss.

  4. Tinnitus Assessment [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 [Day 1 and Day 90]

    This questionnaire is a patient reported outcome measure.

  6. Patient Global Impression of Change (PGI-C) Hearing Loss Scale [Day 90]

    This questionnaire is a patient reported outcome measure.

  7. Patient Global Impression of Change (PGI-C) Daily Impacts Scale [Day 90]

    This questionnaire is a patient reported outcome measure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Trial Site Tucson Arizona United States 00000
2 Clinical Trial Site Fresno California United States 00000
3 Clinical Trial Site Torrance California United States 00000
4 Clinical Trial Site Colorado Springs Colorado United States 00000
5 Clinical Trial Site Sarasota Florida United States 00000
6 Clinical Trial Site Tampa Florida United States 00000
7 Clinical Trial Site Marrero Louisiana United States 00000
8 Clinical Trial Site Novi Michigan United States 00000
9 Clinical Trial Site Omaha Nebraska United States 00000
10 Clinical Trial Site Albany New York United States 00000
11 Clinical Trial Site Amherst New York United States 00000
12 Clinical Trial Site New York New York United States 00000
13 Clinical Trial Site Winston-Salem North Carolina United States 00000
14 Clinical Trial Site Cincinnati Ohio United States 00000
15 Clinical Trial Site Oklahoma City Oklahoma United States 00000
16 Clinical Trial Site Charleston South Carolina United States 00000
17 Clinical Trial Site Orangeburg South Carolina United States 00000
18 Clinical Trial Site Spartanburg South Carolina United States 00000
19 Clinical Trial Site Dallas Texas United States 00000
20 Clinical Trial Site Fort Worth Texas United States 00000
21 Clinical Trial Site San Antonio Texas United States 00000
22 Clinical Trial Site Murray Utah United States 00000
23 Clinical Trial Site Saint George Utah United States 00000
24 Clinical Trial Site Norfolk Virginia United States 00000
25 Clinical Trial Site Richmond Virginia United States 00000
26 Clinical Trial Site Milwaukee Wisconsin United States 00000

Sponsors and Collaborators

  • Frequency Therapeutics

Investigators

  • Study Director: Carl LeBel, PhD, Frequency Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frequency Therapeutics
ClinicalTrials.gov Identifier:
NCT05086276
Other Study ID Numbers:
  • FX-322-208
First Posted:
Oct 20, 2021
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
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:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Noise-Induced
Hearing Loss, Sudden

Study Results

No Results Posted as of Aug 19, 2022