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

Description

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

Conditions

STGD1, Stargardt Disease 1

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Study Overview

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Study Details

Study overview

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy 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

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

Condition
STGD1
Intervention / Treatment

-

Contacts and Locations

San Diego

Belite Study Site, San Diego, California, United States, 92037

Dallas

Belite Study Site, Dallas, Texas, United States, 75231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

12 Years to 20 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Belite Bio, Inc,

Study Record Dates

2027-07