NCT07627971
Open-label Study of SKY-GJB2 in Pediatric Subjects With GJB2-mediated Hearing Loss
Recruiting
PHASE1Ages 9–7InterventionalTreatmentSkylark Bio Inc.
~10 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:SKY-GJB2
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety/Frequency of Adverse Events (AEs)
Measured over Through trial completion, approximately one year
Conditions
Where it's being run
3 sites across 3 statesMassachusetts1
Oklahoma1
Pennsylvania1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Male or female aged 9 months to 7 years at the time of gene therapy administration
Subjects must have at least two (biallelic) pathogenic or likely pathogenic variants in the GJB2 gene
Bilateral sensorineural hearing loss as assessed by ABR. Hearing loss at ≥85 dB HL for at least one of the frequencies (500-4000 Hz) in the study treatment ear.
Subject's parent(s)/guardian(s) provide informed consent before the initiation of study-related procedures.
Subject is able and willing to comply (or provide assent if old enough) will all study requirements.
Exclusion
Subject has non-GJB2 mediated hearing loss including genetic, syndromic, or non-syndromic hearing loss that is not associated with GJB2 mutations.
Subject has autosomal dominant nonsyndromic hearing loss due to GJB2 mutation.
No response on ABR testing.
Bilateral Cochlear Implants.
What this trial measures
- Safety/Frequency of Adverse Events (AEs)Through trial completion, approximately one year
AEs as it relates to the the gene therapy (SKY-GJB2) and/or to the administration procedure (including the delivery device system (SKY-CAT))