Phase 2 Hearing Loss Trial, Recruiting NCT07627971 Sponsor: Skylark Bio Inc. Condition: Hearing Loss
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Phase 2 Hearing Loss Trial, Recruiting

NCT07627971
Recruiting Phase 2

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:

  • The child must be between 9 months and 7 years old at the time of receiving the gene therapy
  • The child must have at least two faulty copies of a specific gene called GJB2 (one inherited from each parent) that are known or likely to cause hearing problems
  • The child must have hearing loss in both ears of a nerve-related type, with significant hearing loss (85 decibels or more) at certain sound frequencies in the ear being treated, as measured by a specialist hearing test called ABR
  • The child's parent(s) or guardian(s) must give their formal written agreement to take part before anything related to the study begins
  • The child must be able and willing to follow all the requirements of the study (and give their own agreement if they are old enough to do so)

Who may not be able to join:

  • The child's hearing loss is caused by something other than faults in the GJB2 gene, including other genetic causes or hearing loss linked to a broader medical condition
  • The child's hearing loss caused by a GJB2 gene fault is inherited in a specific way where only one faulty copy of the gene is passed down (confirm with trial site)
  • The child shows no response at all during the ABR hearing test
  • The child already has cochlear implants in both ears

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Skylark Bio Inc.
Registry
ClinicalTrials.gov
Start date
28 May 2026
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety/Frequency of Adverse Events (AEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov