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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: STGD1, Stargardt Disease 1

In brief

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

Key facts

Study ID

NCT06388083

Run by

Belite Bio, Inc

People needed

60

Starts

2024-07-31

Expected to finish

2028-02-01

Last updated by the study team

2026-03-12

Who can join

Age: 12 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Belite Study Site - US08 — Phoenix, Arizona, United States
• Belite Study Site - US05 — La Jolla, California, United States
• Belite Study Site - US09 — San Francisco, California, United States
• Belite Study Site - US06 — Miami, Florida, United States
• Belite Study Site - US01 — Boston, Massachusetts, United States
• Belite Study Site - US11 — Edina, Minnesota, United States
• Belite Study Site - US04 — Rochester, Minnesota, United States
• Belite Study Site - US14 — New York, New York, United States
• Belite Study Site - US10 — Westbury, New York, United States
• Belite Study Site - US02 — Durham, North Carolina, United States
• Belite Study Site - US07 — Philadelphia, Pennsylvania, United States
• Belite Study Site - US13 — Austin, Texas, United States
• Belite Study Site - US03 — Dallas, Texas, United States
• Belite Study Site - US12 — The Woodlands, Texas, United States
• Belite Study Site — Kobe, Japan
• Belite Study Site — Kyoto, Japan
• Belite Study Site — Tokyo, Japan
• UK01 Belite Study Site — London, United Kingdom

Full record on ClinicalTrials.gov

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