A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
← catalyst calendarNCT05788536 · readout in 921 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
36estimated
Sites
17
Countries
Germany, Japan, Spain +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-06-27 | actual | When the study began enrolling |
| Primary completion | 2029-02-26 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-02-25 | estimated | The whole study's end, after follow-up |
| First posted | 2023-03-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
Intervention
- Genetic: DB-OTO — also filed as Otarmeni™, Otoferlin
Primary outcomes
what the primary-completion date above is the date OFIncidence and severity of Treatment-Emergent Adverse Events (TEAEs)
measured Up to week 104
Achievement of a hearing sensitivity threshold of ≤70 dB assessed by average Pure Tone Audiometry (PTA)
measured Up to week 104
Publications
- PMID 41085057 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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