Sensorineural Hearing LossPhase 2NCT04120116

FX-322 in Adults With Stable Sensorineural Hearing Loss

A Phase 2 study testing FX-322 (One Dose), FX-322 (Two Doses) and FX-322 (Four Doses) in people with Sensorineural Hearing Loss and Noise Induced Hearing Loss, run by Frequency Therapeutics at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Sensorineural Hearing Loss, Noise Induced Hearing Loss, Sudden Sensorineural Hearing Loss
What is being tested?: FX-322 (One Dose), FX-322 (Two Doses) and FX-322 (Four Doses)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 16 sitesUnited States
Study dates: 4 Oct 2019to 17 Dec 2020
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

Adults aged 18-65 years inclusive.
Established diagnosis of stable sensorineural hearing loss by standard audiometric measures for ≥ 6 months prior to the Screening visit (no changes in air conduction greater than 10 dB at a single frequency or greater than 5 dB at two contiguous frequencies from the prior audiogram to the Screening audiogram in the study ear).
Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss.
Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected.
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 or an intrauterine device and condoms) 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.

Who cannot join

Previous participation in FX-322 clinical trial.
Currently on any medication consisting of valproic acid, valproate sodium, or divalproex sodium.
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 10 dB at two or more contiguous octave frequencies in the study ear at the Screening visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).
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 6 months of the screening visit.

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History of clinically significant vestibular symptoms at the discretion of the investigator.
History of clinically significant systemic autoimmune disease.
History of head or neck radiation treatment or exposure.
History of platinum-based chemotherapy treatment.
Exposure to another investigational drug within 28 days prior to injection of study drug.
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).
History of substance abuse within 2 years of the Screening Visit.
Positive test for drugs of abuse at screening.
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 (e.g. previous high-dose aminoglycoside treatment).

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Clinical Trial Site
Amherst, New York, 14226
Clinical Trial Site
Austin, Texas, 78705
Clinical Trial Site
Boca Raton, Florida, 33487
Clinical Trial Site
Colorado Springs, Colorado, 80909
Clinical Trial Site
Fresno, California, 93720
Clinical Trial Site
Louisville, Kentucky, 40207
Clinical Trial Site
Matthews, North Carolina, 28105
Clinical Trial Site
Omaha, Nebraska, 68118
Clinical Trial Site
Orangeburg, South Carolina, 29118
Clinical Trial Site
Richmond, Virginia, 23235
Clinical Trial Site
San Antonio, Texas, 78240
Clinical Trial Site
San Antonio, Texas, 78258
Clinical Trial Site
Sarasota, Florida, 34239
Clinical Trial Site
Tampa, Florida, 33612
Clinical Trial Site
Torrance, California, 90503
Clinical Trial Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 2a, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single and Repeat-Dose, Multicenter, Exploratory Efficacy Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss

This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

Read the detailed description

Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. This phase 2a study will assess the exploratory efficacy, as well as the local and systemic safety of single and repeat intratympanic doses of FX-322 compared to placebo in approximately 96 subjects with stable mild to moderately severe sensorineural hearing loss, with a medical history consistent with either excessive noise exposure or idiopathic sudden sensorineural hearing loss.

Conditions: Sensorineural Hearing Loss, Noise Induced Hearing Loss, Sudden Sensorineural Hearing Loss
Being tested: FX-322 (One Dose), FX-322 (Two Doses), FX-322 (Four Doses), Placebo
Keywords: Intratympanic Administration, Restoration of Hearing Function
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-322 (One Dose)Drug
Patients will receive one dose of FX-322.
FX-322 (Two Doses)Drug
Patients will receive two doses of FX-322.
FX-322 (Four Doses)Drug
Patients will receive four doses of FX-322.
PlaceboDrug
Patients will receive Placebo.

Study groups in NCT04120116
Study group	Role	What they receive
FX-322 Single Dose, Placebo Three Doses	Experimental	Four intratympanic injections of a hydrogel formulation, FX-322 Single Dose, Placebo Three Doses. Receives: Drug: FX-322 (One Dose); Drug: Placebo
FX-322 Two Doses, Placebo Two Doses	Experimental	Four intratympanic injections of a hydrogel formulation, FX-322 Two Doses, Placebo Two Doses. Receives: Drug: FX-322 (Two Doses); Drug: Placebo
FX-322 Four Doses	Experimental	Four intratympanic injections of a hydrogel formulation, FX-322 Four Doses. Receives: Drug: FX-322 (Four Doses)
Placebo Four Doses	Placebo comparator	Four intratympanic injections of a hydrogel formulation, Placebo Four Doses. 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 to Day 210
Words-in-Noise
Mean absolute percent change in number of recognized words from CNC word lists
Measured: Baseline to Day 210
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 4kHZ frequencies
Measured: Baseline to Day 210
Treatment-emergent Adverse Events (TEAEs)
Number of patients with treatment-related adverse events assessed by CTCAE v5.0
Measured: Baseline to Day 210
Otoscopy Abnormalities
Number of treated ears with abnormalities of the external ear canal, tympanic membrane and middle ear at each specified time point
Measured: Baseline and Days 8, 15, 21 60, 90,150, and 210
Tympanometry Abnormalities
Number of treated ears with changes in middle ear compliance (mL), peak pressure (daPa), and/or ear canal volume (mL) from baseline
Measured: Baseline and Days 15, 60, 90, 150, 210

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 201917 Dec 2020

First posted9 Oct 2019
Study start4 Oct 2019
Primary completion6 Oct 2020
Study completion17 Dec 2020

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 Sensorineural Hearing LossStudies 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: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04120116
Sponsor's protocol ID: FX-322-202
Status last verified: Apr 2023
First submitted: 30 Sep 2019
Last updated: 27 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
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Enrolling by invitationObservational study
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All Sensorineural Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single and Repeat-Dose, Multicenter, Exploratory Efficacy Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss
ClinicalTrials.gov ID: NCT04120116
Acronym / sponsor ID: FX-322-202
Conditions: Sensorineural Hearing Loss, Noise Induced Hearing Loss, Sudden Sensorineural Hearing Loss
Keywords: Intratympanic Administration, Restoration of Hearing Function
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Frequency TherapeuticsIndustry (pharma, biotech, devices)
Study start: 4 Oct 2019 (actual)
Primary completion: 6 Oct 2020 (actual)
Study completion: 17 Dec 2020 (actual)
First posted: 9 Oct 2019 (actual)
Results: Posted 27 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 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
FX-322 Single Dose, Placebo Three Doses	Experimental	Drug: FX-322 (One Dose), Drug: PlaceboFour intratympanic injections of a hydrogel formulation, FX-322 Single Dose, Placebo Three Doses.
FX-322 Two Doses, Placebo Two Doses	Experimental	Drug: FX-322 (Two Doses), Drug: PlaceboFour intratympanic injections of a hydrogel formulation, FX-322 Two Doses, Placebo Two Doses.
FX-322 Four Doses	Experimental	Drug: FX-322 (Four Doses)Four intratympanic injections of a hydrogel formulation, FX-322 Four Doses.
Placebo Four Doses	Placebo comparator	Drug: PlaceboFour intratympanic injections of a hydrogel formulation, Placebo Four Doses.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adults aged 18-65 years inclusive.
Established diagnosis of stable sensorineural hearing loss by standard audiometric measures for ≥ 6 months prior to the Screening visit (no changes in air conduction greater than 10 dB at a single frequency or greater than 5 dB at two contiguous frequencies from the prior audiogram to the Screening audiogram in the study ear).
Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss.
Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected.
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 or an intrauterine device and condoms) 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.

Key exclusion criteria (16 listed)

Previous participation in FX-322 clinical trial.
Currently on any medication consisting of valproic acid, valproate sodium, or divalproex sodium.
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 10 dB at two or more contiguous octave frequencies in the study ear at the Screening visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).
Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.

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-322 (One Dose)Patients will receive one dose of FX-322.	Drug	FX-322 Single Dose, Placebo Three Doses
FX-322 (Two Doses)Patients will receive two doses of FX-322.	Drug	FX-322 Two Doses, Placebo Two Doses
FX-322 (Four Doses)Patients will receive four doses of FX-322.	Drug	FX-322 Four Doses
PlaceboPatients will receive Placebo.	Drug	FX-322 Single Dose, Placebo Three Doses, FX-322 Two Doses, Placebo Two Doses, Placebo Four Doses

Primary outcome

Word Recognition in Quiet
Time frame: Baseline to Day 210
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
Words-in-Noise
Time frame: Baseline to Day 210
Mean absolute percent change in number of recognized words from CNC word lists
Pure Tone Audiometry
Time frame: Baseline to Day 210
Mean overall pure tone average (PTA) hearing thresholds in decibels (dB) derived by averaging the air conduction thresholds at 0.5, 1, 2 and 4kHZ frequencies
Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline to Day 210
Number of patients with treatment-related adverse events assessed by CTCAE v5.0
Otoscopy Abnormalities
Time frame: Baseline and Days 8, 15, 21 60, 90,150, and 210
Number of treated ears with abnormalities of the external ear canal, tympanic membrane and middle ear at each specified time point
Tympanometry Abnormalities
Time frame: Baseline and Days 15, 60, 90, 150, 210
Number of treated ears with changes in middle ear compliance (mL), peak pressure (daPa), and/or ear canal volume (mL) from baseline

Results and safety

Results posted to the registry on 27 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: FX-322 Single Dose, Placebo Three Doses	23	22
Group 2: FX-322 Two Doses, Placebo Two Doses	25	24
Group 3: FX-322 Four Doses	24	22
Group 4: Placebo Four Doses	23	20

Primary outcome: Word Recognition in Quiet

Time frame: Baseline to Day 210. Number. Unit: Percent

Measure	Group 1: FX-322 Single Dose, Placebo Three Doses n = 21	Group 2: FX-322 Two Doses, Placebo Two Doses n = 24	Group 3: FX-322 Four Doses n = 19	FX-322 Pooled n = 64	Group 4: Placebo Four Doses n = 17
Value	23.8	16.7	15.8	18.8	41.2

FX-322 Pooled vs Group 4: Placebo Four Doses: Odds Ratio (OR): 0.3 (95% CI 0.11 to 1.08), p = 0.068, Mixed Models Analysis

Population analysed: Full Analysis Set is defined as all randomized subjects who received at least one dose of study drug or placebo in the study ear per the randomized treatment schedule. Only data from subjects in the FAS that attended the Day 210 visit were analyzed for this endpoint. The FX-322 Pooled Group consists of subjects in the Groups 1, 2, and 3 combined. The Pooled Group is for analysis only and does not signify a separate randomized group of subjects.

Primary outcome: Words-in-Noise

Time frame: Baseline to Day 210. Mean (Standard Deviation). Unit: Percent change

Measure	Group 1: FX-322 Single Dose, Placebo Three Doses n = 21	Group 2: FX-322 Two Doses, Placebo Two Doses n = 24	Group 3: FX-322 Four Doses n = 19	FX-322 Pooled n = 64	Group 4: Placebo Four Doses n = 17
Value	2.58 (7.251)	3.33 (8.933)	1.80 (7.236)	2.63 (7.822)	3.61 (11.259)

Primary outcome: Pure Tone Audiometry

Time frame: Baseline to Day 210. Least squares mean (Standard Error). Unit: Decibels (dB)

Measure	Group 1: FX-322 Single Dose, Placebo Three Doses n = 21	Group 2: FX-322 Two Doses, Placebo Two Doses n = 24	Group 3: FX-322 Four Doses n = 19	FX-322 Pooled n = 64	Group 4: Placebo Four Doses n = 17
Value	54.92 (2.284)	55.08 (2.175)	52.44 (2.372)	54.15 (1.417)	52.90 (2.404)

FX-322 Pooled vs Group 4: Placebo Four Doses: Least squares mean difference: 1.25 (95% CI -3.945 to 6.439), p = 0.634, Mixed Models Analysis

Population analysed: Full Analysis Set is defined as all randomized subjects who received at least one dose of study drug or placebo in the study ear per the randomized treatment schedule. Only data from subjects in the FAS that attended the Day 210 visit were analyzed for this endpoint. FX-322 Pooled Group consists of subjects in the Groups 1, 2, and 3 combined. The Pooled Group is for analysis only and does not signify a separate randomized group of subjects.

Primary outcome: Treatment-emergent Adverse Events (TEAEs)

Time frame: Baseline to Day 210. Count of participants. Unit: Participants

Measure	Group 1: FX-322 Single Dose, Placebo Three Doses n = 24	Group 2: FX-322 Two Doses, Placebo Two Doses n = 25	Group 3: FX-322 Four Doses n = 21	Group 4: Placebo Four Doses n = 23	Total n = 95
Value	16	16	19	12	64

Population analysed: Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For TEAEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for TEAEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.

Adverse events

Time frame: Baseline through Day 210. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: FX-322 Single Dose, Placebo Three Doses	0 of 24 (0%)	16 of 24 (66.7%)	0 of 24
Group 2: FX-322 Two Doses, Placebo Two Doses	0 of 25 (0%)	16 of 25 (64%)	0 of 25
Group 3: FX-322 Four Doses	0 of 21 (0%)	19 of 21 (90.5%)	0 of 21
Group 4: Placebo Four Doses	0 of 23 (0%)	12 of 23 (52.2%)	0 of 23
Total	1 of 95 (1.1%)	64 of 95 (67.4%)	0 of 95

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 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

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 16 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 27 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 16 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 27 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 to Day 210). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04120116.

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 27 Apr 2023.