A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B

NCT02065011 · tracked via the Priya Life Science USA tracker

Sponsor

Sanofi

Phase

Phase 2

Started

2013-09-12

Last updated

2026-01-13

Condition(s) studied

Usher's Syndrome

Investigational drug(s) / intervention(s)

Blood draw for the laboratory assessment

Study summary

Primary Objective:

To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B

Secondary Objective:

To assess long-term safety and biological activity of SAR421869

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion criteria : Provide signed and dated written informed consent (and if appropriate assent) and any locally required authorization eg, Health Insurance Portability and Accountability Act (HIPAA). Must have been enrolled in protocol TDU13600. Must have received a subretinal injection of SAR421869 Exclusion criteria: Did not receive SAR421869 as part of the TDU13600 protocol.

Primary outcome measure(s)

The incidence of adverse events — 15 years
The number and percentage of patients with treatment emergent adverse events

Trial sites (2)

Facility	City	Region	Status
Oregon Health and Science University Site Number : 840001	Portland	Oregon
Investigational Site Number : 250001	Paris	France

More Sanofi trials in the USA

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis Active, not recruiting

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation Recruiting

A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work Active, not recruiting

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS) Enrolling by invitation

Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02065011 on ClinicalTrials.gov ↗ ← All trials in the USA