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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
Results First Posted : April 21, 2023
Last Update Posted : April 21, 2023
Sponsor:
Information provided by (Responsible Party):
Frequency Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hearing Loss, Sensorineural
Noise Induced Hearing Loss
Sudden Hearing Loss
Interventions Drug: FX-322
Drug: Placebo
Enrollment 142
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FX-322 Placebo
Hide Arm/Group Description Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear Single intratympanic injection of placebo into affected ear
Period Title: Overall Study
Started 70 72
Completed 69 71
Not Completed 1 1
Reason Not Completed
Missed visit 5/Day 60 visit             1             1
Arm/Group Title FX-322 Placebo Total
Hide Arm/Group Description Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear Single intratympanic injection of placebo into affected ear Total of all reporting groups
Overall Number of Baseline Participants 68 72 140
Hide Baseline Analysis Population Description
Full analysis set is defined as the subjects who met all inclusion criteria who received at least 1 dose of study drug. Note that 2 subjects who received FX-322 treatment were ultimately not included in the Full Analysis Set because, after they had been treated and as study assessments progressed, they were deemed to not meet the inclusion criteria for sensorineural hearing loss (SNHL) and were excluded from the FAS.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 72 participants 140 participants
52.9  (11.12) 50.6  (12.20) 51.7  (11.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 72 participants 140 participants
Female
16
  23.5%
29
  40.3%
45
  32.1%
Male
52
  76.5%
43
  59.7%
95
  67.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 72 participants 140 participants
Hispanic or Latino
6
   8.8%
9
  12.5%
15
  10.7%
Not Hispanic or Latino
61
  89.7%
63
  87.5%
124
  88.6%
Unknown or Not Reported
1
   1.5%
0
   0.0%
1
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 72 participants 140 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   8.8%
5
   6.9%
11
   7.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.5%
2
   2.8%
3
   2.1%
White
60
  88.2%
64
  88.9%
124
  88.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.5%
1
   1.4%
2
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants 72 participants 140 participants
68 72 140
1.Primary Outcome
Title Word Recognition in Quiet
Hide Description 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
Time Frame Baseline through Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Arm/Group Title FX-322 Placebo
Hide Arm/Group Description:
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
Single intratympanic injection of placebo into affected ear
Overall Number of Participants Analyzed 68 72
Measure Type: Number
Unit of Measure: Percent of subjects
14.7 11.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FX-322, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.525
Comments P value for statistical significance is <0.05
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
0.51 to 3.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FX-322, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.525
Comments P value for statistical significance is <0.05
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
-7.52 to 14.71
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Words-in-Noise
Hide Description Mean absolute percent change in number of recognized words from CNC word lists
Time Frame Baseline through Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Arm/Group Title FX-322 Placebo
Hide Arm/Group Description:
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
Single intratympanic injection of placebo into affected ear
Overall Number of Participants Analyzed 67 72
Mean (Standard Deviation)
Unit of Measure: Percent change
0.17  (2.465) 0.35  (3.295)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FX-322, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments P value for statistical significance is <0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.954 to 0.987
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.491
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Standard Pure Tone Audiometry
Hide Description 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
Time Frame Baseline through Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Arm/Group Title FX-322 Placebo
Hide Arm/Group Description:
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
Single intratympanic injection of placebo into affected ear
Overall Number of Participants Analyzed 68 72
Mean (Standard Deviation)
Unit of Measure: Decibels (dB)
65.09  (7.865) 63.91  (9.816)
4.Secondary Outcome
Title Patient Global Impression of Change (PGI-C) Hearing Loss Scale
Hide Description 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
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Arm/Group Title FX-322 Placebo
Hide Arm/Group Description:
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
Single intratympanic injection of placebo into affected ear
Overall Number of Participants Analyzed 68 71
Mean (Standard Deviation)
Unit of Measure: Score on a scale
3.0  (0.52) 2.9  (0.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FX-322, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments P value for statistical significance is <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.06 to 0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Patient Global Impression of Change (PGI-C) Daily Impacts Scale
Hide Description 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
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Arm/Group Title FX-322 Placebo
Hide Arm/Group Description:
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
Single intratympanic injection of placebo into affected ear
Overall Number of Participants Analyzed 68 71
Mean (Standard Deviation)
Unit of Measure: Score on a scale
3.0  (0.53) 2.8  (0.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FX-322, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments P value for statistical significance is <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.03 to 0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Time Frame Baseline through Day 90
Adverse Event Reporting Description Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
 
Arm/Group Title FX-322 Placebo
Hide Arm/Group Description Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear Single intratympanic injection of placebo into affected ear
All-Cause Mortality
FX-322 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/72 (0.00%) 
Hide Serious Adverse Events
FX-322 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/70 (1.43%)   1/72 (1.39%) 
Infections and infestations     
Device-related infection † 1 [1]  0/70 (0.00%)  1/72 (1.39%) 
Pneumonia parainfluenzae viral † 1  0/70 (0.00%)  1/72 (1.39%) 
Sepsis † 1  0/70 (0.00%)  1/72 (1.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Extragonadal primary seminoma † 1 [2]  1/70 (1.43%)  0/72 (0.00%) 
Nervous system disorders     
Encephalopathy † 1  0/70 (0.00%)  1/72 (1.39%) 
1
Term from vocabulary, MedDRA v25.1
†
Indicates events were collected by systematic assessment
[1]
One subject experienced a device-related infection, pneumonia parainfluenzae viral, sepsis, and encephalopathy. These SAEs were not deemed related to the study drug
[2]
One subject developed a seminoma during the trial period. This was not deemed related to the study drug.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FX-322 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   41/70 (58.57%)   44/72 (61.11%) 
Blood and lymphatic system disorders     
Iron deficiency anemia † 1  0/70 (0.00%)  1/72 (1.39%) 
Lymphadenopathy † 1  0/70 (0.00%)  1/72 (1.39%) 
Cardiac disorders     
Palpitations † 1  0/70 (0.00%)  1/72 (1.39%) 
Ear and labyrinth disorders     
Tinnitus † 1  8/70 (11.43%)  7/72 (9.72%) 
Ear pain † 1  3/70 (4.29%)  3/72 (4.17%) 
Vertigo † 1  0/70 (0.00%)  4/72 (5.56%) 
Ear discomfort † 1  2/70 (2.86%)  1/72 (1.39%) 
Cerumen impaction † 1  1/70 (1.43%)  1/72 (1.39%) 
Eustachian tube dysfunction † 1  2/70 (2.86%)  0/72 (0.00%) 
Deafness unilateral † 1  1/70 (1.43%)  0/72 (0.00%) 
Hypoacusis † 1  1/70 (1.43%)  0/72 (0.00%) 
Meniere's disease † 1  1/70 (1.43%)  0/72 (0.00%) 
Middle ear effusion † 1  1/70 (1.43%)  0/72 (0.00%) 
Myringosclerosis † 1  1/70 (1.43%)  0/72 (0.00%) 
Ototoxicity † 1  1/70 (1.43%)  0/72 (0.00%) 
Eye disorders     
Blepharospasm † 1  0/70 (0.00%)  1/72 (1.39%) 
Gastrointestinal disorders     
Gastroesophageal reflux disease † 1  1/70 (1.43%)  0/72 (0.00%) 
Intussusception † 1  1/70 (1.43%)  0/72 (0.00%) 
Nausea † 1  1/70 (1.43%)  0/72 (0.00%) 
General disorders     
Injection site pain † 1  13/70 (18.57%)  7/72 (9.72%) 
Injection site scab † 1  2/70 (2.86%)  1/72 (1.39%) 
Pyrexia † 1  1/70 (1.43%)  1/72 (1.39%) 
Chest pain † 1  0/70 (0.00%)  1/72 (1.39%) 
Injection site discomfort † 1  1/70 (1.43%)  0/72 (0.00%) 
Injection site hemorrhage † 1  1/70 (1.43%)  0/72 (0.00%) 
Edema † 1  0/70 (0.00%)  1/72 (1.39%) 
Immune system disorders     
Seasonal allergy † 1  1/70 (1.43%)  0/72 (0.00%) 
Infections and infestations     
COVID-19 † 1  5/70 (7.14%)  7/72 (9.72%) 
Bronchitis † 1  2/70 (2.86%)  1/72 (1.39%) 
Pharyngitis streptococcal † 1  0/70 (0.00%)  2/72 (2.78%) 
Sinusitis † 1  1/70 (1.43%)  1/72 (1.39%) 
Urinary tract infection † 1  0/70 (0.00%)  2/72 (2.78%) 
Candida infection † 1  1/70 (1.43%)  0/72 (0.00%) 
Device-related infection † 1  0/70 (0.00%)  1/72 (1.39%) 
Ear injection † 1  1/70 (1.43%)  0/72 (0.00%) 
Herpes zoster † 1  0/70 (0.00%)  1/72 (1.39%) 
Influenza † 1  1/70 (1.43%)  0/72 (0.00%) 
Otitis externa † 1  0/70 (0.00%)  1/72 (1.39%) 
Otitis media † 1  1/70 (1.43%)  0/72 (0.00%) 
Pneumonia parainfluenze viral † 1  0/70 (0.00%)  1/72 (1.39%) 
Respiratory tract infection † 1  0/70 (0.00%)  1/72 (1.39%) 
Rhinovirus infection † 1  1/70 (1.43%)  0/72 (0.00%) 
Sepsis † 1  0/70 (0.00%)  1/72 (1.39%) 
Injury, poisoning and procedural complications     
Limb injury † 1  1/70 (1.43%)  0/72 (0.00%) 
Skin laceration † 1  1/70 (1.43%)  0/72 (0.00%) 
Investigations     
Audiogram abnormal † 1  16/70 (22.86%)  22/72 (30.56%) 
Blood pressure increased † 1  1/70 (1.43%)  1/72 (1.39%) 
Blood creatine phosphokinase increased † 1  0/70 (0.00%)  1/72 (1.39%) 
Blood triglycerides increased † 1  0/70 (0.00%)  1/72 (1.39%) 
Drug screen positive † 1  1/70 (1.43%)  0/72 (0.00%) 
Metabolism and nutrition disorders     
Hyperammonemia † 1  0/70 (0.00%)  1/72 (1.39%) 
Hyperglycemia † 1  0/70 (0.00%)  1/72 (1.39%) 
Hyperlipidemia † 1  0/70 (0.00%)  1/72 (1.39%) 
Hypoalbuminemia † 1  0/70 (0.00%)  1/72 (1.39%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms † 1  1/70 (1.43%)  0/72 (0.00%) 
Musculoskeletal discomfort † 1  0/70 (0.00%)  1/72 (1.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Extragonadal primary seminoma † 1  1/70 (1.43%)  0/72 (0.00%) 
Nervous system disorders     
Dizziness † 1  2/70 (2.86%)  2/72 (2.78%) 
Seizure † 1  1/70 (1.43%)  1/72 (1.39%) 
Encephalopathy † 1  0/70 (0.00%)  1/72 (1.39%) 
Headache † 1  0/70 (0.00%)  1/72 (1.39%) 
Syncope † 1  0/70 (0.00%)  1/72 (1.39%) 
Psychiatric disorders     
Decreased interest † 1  1/70 (1.43%)  0/72 (0.00%) 
Depressed mood † 1  1/70 (1.43%)  0/72 (0.00%) 
Feeling of despair † 1  1/70 (1.43%)  0/72 (0.00%) 
Renal and urinary disorders     
Calculus bladder † 1  0/70 (0.00%)  1/72 (1.39%) 
Reproductive system and breast disorders     
Scrotal pain † 1  0/70 (0.00%)  1/72 (1.39%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  0/70 (0.00%)  2/72 (2.78%) 
Oropharyngeal pain † 1  0/70 (0.00%)  2/72 (2.78%) 
Nasal congestion † 1  0/70 (0.00%)  1/72 (1.39%) 
Pleurisy † 1  0/70 (0.00%)  1/72 (1.39%) 
Rhinitis allergic † 1  0/70 (0.00%)  1/72 (1.39%) 
Skin and subcutaneous tissue disorders     
Rash † 1  1/70 (1.43%)  0/72 (0.00%) 
Skin ulcer † 1  0/70 (0.00%)  1/72 (1.39%) 
Urticaria † 1  0/70 (0.00%)  1/72 (1.39%) 
Vascular disorders     
Hypertension † 1  1/70 (1.43%)  0/72 (0.00%) 
1
Term from vocabulary, MedDRA v25.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PIs must obtain sponsor's written consent before publishing or presenting the trial results
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Frequency Therapeutics
Phone: 781-315-4600
EMail: clinicaltrialsinformation@frequencytx.com
Layout table for additonal information
Responsible Party: Frequency Therapeutics
ClinicalTrials.gov Identifier: NCT05086276    
Other Study ID Numbers: FX-322-208
First Submitted: October 8, 2021
First Posted: October 20, 2021
Results First Submitted: March 30, 2023
Results First Posted: April 21, 2023
Last Update Posted: April 21, 2023