ACTIVE_NOT_RECRUITING

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy

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

This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.

Official Title

PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study)

Quick Facts

Study Start:2023-07-27
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05949593

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:60 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
  2. * Minimum BCVA is required in the study eye
  1. * The presence of diabetic macular edema or macular disease in either eye.
  2. * Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
  3. * Uncontrolled diagnosed glaucoma in the study eye

Contacts and Locations

Study Locations (Sites)

Belite Study Site
Phoenix, Arizona, 85020
United States
Belite Study Site
Arcadia, California, 91007
United States
Belite Study Site
Beverly Hills, California, 90211
United States
Belite Study Site
Huntington Beach, California, 92467
United States
Belite Study Site
Los Angeles, California, 90033
United States
Belite Study Site
Palo Alto, California, 94303
United States
Belite Study Site
San Diego, California, 92093
United States
Belite Study Site
Lakeland, Florida, 33805
United States
Belite Study Site
Hagerstown, Maryland, 21740
United States
Belite Study Site
Saint Louis Park, Minnesota, 55416
United States
Belite Study Site
Westbury, New York, 11590
United States
Belite Study Site
Cary, North Carolina, 27511
United States
Belite Study Site
Durham, North Carolina, 27710
United States
Belite Study Site
Wake Forest, North Carolina, 27587
United States
Belite Study Site
Portland, Oregon, 97239
United States
Belite Study Site
Philadelphia, Pennsylvania, 19107
United States
Belite Study Site
Sewickley, Pennsylvania, 15143
United States
Belite Study Site
Germantown, Tennessee, 38138
United States
Belite Study Site
Abilene, Texas, 79606
United States
Belite Study Site
Dallas, Texas, 75231
United States
Belite Study Site
San Antonio, Texas, 78240
United States
Belite Study Site
Warrenton, Virginia, 20186
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 Date2023-07-27
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-07-27
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • LBS-008
  • Tinlarebant
  • GA

Additional Relevant MeSH Terms

  • Geographic Atrophy