Hearing Loss, SensorineuralPhase 2NCT05086276
FX-322 in Adults With Acquired Sensorineural Hearing Loss
A Phase 2 study testing FX-322 in people with Hearing Loss, Sensorineural and Noise Induced Hearing Loss, run by Frequency Therapeutics at 26 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Noise Induced Hearing Loss, Sudden Hearing Loss
- What is being tested?
- FX-322
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 26 sitesUnited States
- Study dates
- 12 Oct 2021to 30 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Clinical Trial Site
Albany, New York, 00000
Clinical Trial Site
Amherst, New York, 00000
Clinical Trial Site
Charleston, South Carolina, 00000
Clinical Trial Site
Cincinnati, Ohio, 00000
Clinical Trial Site
Colorado Springs, Colorado, 00000
Clinical Trial Site
Dallas, Texas, 00000
Clinical Trial Site
Fort Worth, Texas, 00000
Clinical Trial Site
Fresno, California, 00000
Clinical Trial Site
Marrero, Louisiana, 00000
Clinical Trial Site
Milwaukee, Wisconsin, 00000
Clinical Trial Site
Murray, Utah, 00000
Clinical Trial Site
New York, New York, 00000
Clinical Trial Site
Norfolk, Virginia, 00000
Clinical Trial Site
Novi, Michigan, 00000
Clinical Trial Site
Oklahoma City, Oklahoma, 00000
Clinical Trial Site
Omaha, Nebraska, 00000
Clinical Trial Site
Orangeburg, South Carolina, 00000
Clinical Trial Site
Richmond, Virginia, 00000
Clinical Trial Site
San Antonio, Texas, 00000
Clinical Trial Site
Sarasota, Florida, 00000
Clinical Trial Site
Spartanburg, South Carolina, 00000
Clinical Trial Site
St. George, Utah, 00000
Clinical Trial Site
Tampa, Florida, 00000
Clinical Trial Site
Torrance, California, 00000
Clinical Trial Site
Tucson, Arizona, 00000
Clinical Trial Site
Winston-Salem, North Carolina, 00000
About this study
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
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).
Read the 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.
- Being tested
- FX-322, Placebo
- Keywords
- Intratympanic administration, Restoration of hearing loss
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Noise-Induced, Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX-322Drug
Active Comparator
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| FX-322 | Active comparator | FX-322, 1 dose Receives: Drug: FX-322 |
| Placebo | Placebo comparator | Placebo, 1 dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline through Day 90
Secondary outcomes (4)
Words-in-Noise
Mean absolute percent change in number of recognized words from CNC word lists
Measured: Baseline through Day 90
Standard Pure Tone Audiometry
Mean overall pure tone average (PTA) hearing thresholds in decibels (dB) derived by averaging the air conduction thresholds at 0.5, 1, 2 and 4 kHZ frequencies
Measured: Baseline through Day 90
Patient Global Impression of Change (PGI-C) Hearing Loss Scale
Average response in PGI-C hearing loss scale, using the assigned numeric values of 1-5: 1) much better, 2) a little better, 3) no change, 4) a little worse 5) much worse
Measured: Day 90
Patient Global Impression of Change (PGI-C) Daily Impacts Scale
Average response in PGI-C daily impacts scale, using the assigned numeric values of 1-5: 1) much better, 2) a little better, 3) no change, 4) a little worse 5) much worse
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start12 Oct 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frequency Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl LeBel, PhD, Study director, Frequency Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086276
- Sponsor's protocol ID
- FX-322-208
- Status last verified
- Apr 2023
- First submitted
- 8 Oct 2021
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05086276
- Acronym / sponsor ID
- FX-322-208
- Keywords
- Intratympanic administration, Restoration of hearing loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Frequency TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FX-322 | Active comparator | Drug: FX-322FX-322, 1 dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, 1 dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FX-322Active Comparator | Drug | FX-322 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Word Recognition in Quiet
Time frame: Baseline through Day 90
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
4 secondary outcomes
Words-in-Noise
Time frame: Baseline through Day 90
Standard Pure Tone Audiometry
Time frame: Baseline through Day 90
Patient Global Impression of Change (PGI-C) Hearing Loss Scale
Time frame: Day 90
Patient Global Impression of Change (PGI-C) Daily Impacts Scale
Time frame: Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl LeBel, PhD study director
Frequency Therapeutics
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FX-322 in people with Hearing Loss, Sensorineural and Noise Induced Hearing Loss, run by Frequency Therapeutics at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word Recognition in Quiet (time frame: Baseline through Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.