Phase 2 Hearing Loss Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- A parent or legal guardian (for child participants) and/or the adult participant must be willing to sign a consent form and agree to follow the trial's procedures.
- A parent or legal guardian (for child participants) and/or the adult participant must be willing to consent to genetic testing to look at a panel of genes related to hearing loss.
- A parent or legal guardian (for child participants) and/or the adult participant must be willing to consent to vaccinations following the recommended immunisation schedule for the participant's age and country.
- The participant must be able to complete all necessary assessments required for their specific group in the trial at the time consent is signed.
- The participant must have a confirmed genetic result showing two copies of a harmful or likely harmful change in the OTOF gene (the gene linked to this type of hearing loss).
- The participant must have no significant abnormal results on standard blood or laboratory tests at the screening stage.
- A doctor must have diagnosed the participant with profound hearing loss in the inner ear (greater than 90 dB hearing level), confirmed through both behavioural testing and a specialised hearing nerve test (ABR).
- The participant must have evidence that a specific part of the inner ear (outer hair cells) is still working, confirmed through a specific sound-based test in the ear(s) to be treated (confirm with trial site for exact testing requirements based on age).
- The participant's hearing loss must not appear to change with body temperature.
- Participants who could become pregnant or father a child must agree to use highly effective contraception and not become pregnant, father a child, or donate sperm for 48 weeks after treatment (or at least 12 months if leaving the trial early).
Who may not be able to join:
- People who have previously received any gene therapy treatment.
- People whose ear anatomy, as seen on a CT or MRI scan, would make the planned surgical procedure impossible or significantly more difficult in the ear(s) to be treated.
- People who have another permanent or untreatable cause of hearing loss in addition to the OTOF-related hearing loss.
- People with a current or past history of any cancer.
- People with a current or past history of meningitis (an infection causing inflammation around the brain and spinal cord).
- People who have a cochlear implant already in place in the ear(s) to be treated.
- People who have risk factors for a type of hearing loss (auditory neuropathy) caused by reasons other than the OTOF gene change — for example, being born prematurely, having a low birth weight, severe newborn jaundice, admission to a neonatal intensive care unit, or low Apgar scores at birth (confirm with trial site for full details).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Trial Management, Regeneron Pharmaceuticals
Phone: 844-734-6643
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs); Achievement of a hearing sensitivity threshold of ≤70 dB assessed by average Pure Tone Audiometry (PTA)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.