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

a study on Geographic Atrophy

Summary

Eligibility
for people ages 60-85 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by SriniVas R. Sadda, MD (ucla)
Headshot of SriniVas R. Sadda
SriniVas R. Sadda

Description

Summary

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)

Details

Subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. The study treatment will be administered orally once daily from baseline (Day 1) through the final day of Month 24.

Keywords

Geographic Atrophy, LBS-008, Tinlarebant, GA, Atrophy, LBS-008, Tinlarebant

Eligibility

You can join if…

Open to people ages 60-85

  • Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
  • Minimum BCVA is required in the study eye

You CAN'T join if...

Locations

  • Belite Study Site accepting new patients
    Beverly Hills California 90211 United States
  • Belite Study Site accepting new patients
    San Diego California 92093 United States
  • Belite Study Site accepting new patients
    Huntington Beach California 92467 United States
  • Belite Study Site accepting new patients
    Los Angeles California 90033 United States
  • Belite Study Site not yet accepting patients
    Arcadia California 91007 United States
  • Belite Study Site accepting new patients
    Palo Alto California 94303 United States

Lead Scientist at University of California Health

  • SriniVas R. Sadda, MD (ucla)
    Srinivas Sadda, M.D., holds the A. Ray Irvine, Jr., MD, Endowed Chair in Clinical Ophthalmology.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Belite Bio, Inc
ID
NCT05949593
Phase
Phase 3 Geographic Atrophy Research Study
Study Type
Interventional
Participants
Expecting 429 study participants
Last Updated