RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-07-31
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06388083

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.

Ages Eligible for Study:12 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must have clinically diagnosed STGD1 with at least one mutation identified in the ABCA4 gene.
  2. * Subjects must have a defined aggregate atrophic lesion in 1 or both eyes.
  3. * Minimum BCVA is required in the study eye
  1. * Any ocular disease other than STGD1 that, in the opinion of the investigator, would complicate assessment of a treatment effect.
  2. * History of ocular surgery in the study eye in the last 3 months.
  3. * Any prior gene therapy.

Contacts and Locations

Study Contact

Belite Bio Clinical Operations
CONTACT
+886 972 080 097
clinicaltrial@belitebio.com

Study Locations (Sites)

Belite Study Site
San Diego, California, 92037
United States
Belite Study Site
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: Belite Bio, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-31
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-07-31
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • STGD1
  • Stargardt Disease 1