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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06388083
Other study ID # LBS-008-CT07
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 2024
Est. completion date July 2027

Study information

Verified date April 2024
Source Belite Bio, Inc
Contact Belite Bio Clinical Operations
Phone +886 972 080 097
Email clinicaltrial@belitebio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This study will be comprised of a Phase 1b part conducted in Japan and a Phase 2/3 part. The Phase 1b part of the study will be open-label and will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of daily doses of 5 mg tinlarebant, administered for 7 days, in Japanese subjects with Stargardt Disease (STGD1). The Phase 2/3 part of the study will be randomized, double masked, and placebo controlled to evaluate the safety, tolerability, and efficacy of daily doses of 5 mg tinlarebant, administered for 24 months, in subjects with STGD1.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 2027
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender All
Age group 12 Years to 20 Years
Eligibility 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.

Study Design


Intervention

Drug:
Tinlarebant
5 mg tablet
Placebo
Placebo tablets

Locations

Country Name City State
United States Belite Study Site Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Belite Bio, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy From baseline to Month 24
Secondary To measure the annualized rate of change in total area of atrophy From baseline to Month 24
Secondary Change in BCVA measured by the ETDRS method From baseline to Month 24
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