NCT06388083Active, not recruitingPhase 2/3
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease
A Phase 1b Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Tinlarebant in Japanese Subjects With Stargardt Disease and a Phase 2/3 Randomized, Double-masked, and Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Tinlarebant in Subjects With Stargardt Disease
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 23 Apr 2024
- Start date
- 31 Jul 2024
- Primary completion date
- Feb 2028
- Lead sponsor
- Belite Bio, Inc
- NCT number
- NCT06388083
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 60
- From 31 Jul 2024 to the primary completion date, Feb 2028
- 18 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior gene therapy.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 12 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.