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Clinical Trials in Japan / NCT06388083
Active, not recruiting Phase 2/3

A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease

NCT06388083 · tracked via the Priya Life Science Japan tracker
Sponsor
Belite Bio, Inc
Phase
Phase 2/3
Started
2024-07-31
Last updated
2026-03-12

Condition(s) studied

STGD1Stargardt Disease 1

Investigational drug(s) / intervention(s)

Tinlarebant →Placebo

Tinlarebant: 5 mg tablet

Placebo: Placebo tablets

Study summary

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease

Eligibility

Sex
ALL
Min age
12 Years
Max age
20 Years
Healthy volunteers
No
Inclusion Criteria: * Subjects must have clinically diagnosed STGD1 with at least one mutation identified in the ABCA4 gene. * Subjects must have a defined aggregate atrophic lesion in 1 or both eyes. * Minimum BCVA is required in the study eye Exclusion Criteria: * Any ocular disease other than STGD1 that, in the opinion of the investigator, would complicate assessment of a treatment effect. * History of ocular surgery in the study eye in the last 3 months. * Any prior gene therapy.

Primary outcome measure(s)

  • To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy — From baseline to Month 24

Trial sites (18)

FacilityCityRegionStatus
Belite Study Site - US08 Phoenix Arizona
Belite Study Site - US05 La Jolla California
Belite Study Site - US09 San Francisco California
Belite Study Site - US06 Miami Florida
Belite Study Site - US01 Boston Massachusetts
Belite Study Site - US11 Edina Minnesota
Belite Study Site - US04 Rochester Minnesota
Belite Study Site - US14 New York New York
Belite Study Site - US10 Westbury New York
Belite Study Site - US02 Durham North Carolina
Belite Study Site - US07 Philadelphia Pennsylvania
Belite Study Site - US13 Austin Texas
Belite Study Site - US03 Dallas Texas
Belite Study Site - US12 The Woodlands Texas
Belite Study Site Kobe Japan
Belite Study Site Kyoto Japan
Belite Study Site Tokyo Japan
UK01 Belite Study Site London United Kingdom
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 NCT06388083 on ClinicalTrials.gov ↗ ← All trials in Japan