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Study identifier: NCT05788536 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)  ·  Sponsor: Regeneron Pharmaceuticals

PhasePhase 1/Phase 2
Planned participants36
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to changes in the otoferlin gene. The purpose of this study is to: * Learn about the safety of DB-OTO * Determine how well DB-OTO is tolerated (does not cause ongoing discomfort) * Evaluate the efficacy of DB-OTO (how well DB-OTO works)

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trials Administrator  ·  844-734-6643  ·  clinicaltrials@regeneron.com

Always discuss trial participation with your own doctor first.

Locations (16)

University of California Los Angeles Medical CenterLos Angeles, California, United StatesRecruiting
Rady Children's HospitalSan Diego, California, United StatesRecruiting
Nemours Children s ClinicJacksonville, Florida, United StatesRecruiting
Nemours Childrens HospitalOrlando, Florida, United StatesRecruiting
Boston Children's Hospital - MainBoston, Massachusetts, United StatesRecruiting
Columbia University Irving Medical CenterNew York, New York, United StatesRecruiting
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio, United StatesRecruiting
Seattle Children's HospitalSeattle, Washington, United StatesRecruiting
Medical College of WisconsinMilwaukee, Wisconsin, United StatesRecruiting
University Hospital TubingenTübingen, GermanyRecruiting
Shinshu University HospitalMatsumoto-shi, Nagano, JapanRecruiting
Clinica Universidad de Navarra- PamplonaPamplona, Navarre, SpainRecruiting

+ 4 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05788536