Clinical trial NCT05086276: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hearing Loss, Sensorineural
Noise Induced Hearing Loss
Sudden Hearing Loss
Keywords: Intratympanic administration
Restoration of hearing loss
Lead sponsor: Frequency Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-10-20
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Word Recognition in Quiet
timeFrame: Baseline through Day 90
Secondary outcomes:
measure: Words-in-Noise
timeFrame: Baseline through Day 90
measure: Standard Pure Tone Audiometry
timeFrame: Baseline through Day 90
measure: Patient Global Impression of Change (PGI-C) Hearing Loss Scale
timeFrame: Day 90
measure: Patient Global Impression of Change (PGI-C) Daily Impacts Scale
timeFrame: Day 90
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Clinical Trial Site
state: Arizona
city: Fresno
country: United States
facility: Clinical Trial Site
state: California
city: Torrance
country: United States
facility: Clinical Trial Site
state: California
city: Colorado Springs
country: United States
facility: Clinical Trial Site
state: Colorado
city: Sarasota
country: United States
facility: Clinical Trial Site
state: Florida
city: Tampa
country: United States
facility: Clinical Trial Site
state: Florida
city: Marrero
country: United States
facility: Clinical Trial Site
state: Louisiana
city: Novi
country: United States
facility: Clinical Trial Site
state: Michigan
city: Omaha
country: United States
facility: Clinical Trial Site
state: Nebraska
city: Albany
country: United States
facility: Clinical Trial Site
state: New York
city: Amherst
country: United States
facility: Clinical Trial Site
state: New York
city: New York
country: United States
facility: Clinical Trial Site
state: New York
city: Winston-Salem
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Trial Site
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Trial Site
state: Oklahoma
city: Charleston
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Orangeburg
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Spartanburg
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Dallas
country: United States
facility: Clinical Trial Site
state: Texas
city: Fort Worth
country: United States
facility: Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: Murray
country: United States
facility: Clinical Trial Site
state: Utah
city: Saint George
country: United States
facility: Clinical Trial Site
state: Utah
city: Norfolk
country: United States
facility: Clinical Trial Site
state: Virginia
city: Richmond
country: United States
facility: Clinical Trial Site
state: Virginia
city: Milwaukee
country: United States
facility: Clinical Trial Site
state: Wisconsin
Study officials:
affiliation: Frequency Therapeutics
name: Carl LeBel, PhD
role: STUDY_DIRECTOR
References: