CLINICAL TRIALS
Patient Registry
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Tinlarebant (LBS-008) – Phase 3 trial for Geographic Atrophy (the “Phoenix” trial)
Recruitment Status : Recruiting
The PHOENIX trial is Phase 3, multicenter, double-masked, placebo-controlled, randomized, fixed-dose clinical study designed to evaluate the efficacy and safety of Tinlarebant in patients with geographic atrophy associated with Dry AMD. Approximately 430 subjects are targeted for enrollment.
Tinlarebant (LBS-008)-Phase 1b and Phase 2/3 trial for Stargardt Disease (the “DRAGON II” trial)
Recruitment Status: Recruiting
The DRAGON II trial is a combination Phase 1b open-label study to evaluate the pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese adolescent STGD1 subjects and a Phase 2/3, multicenter, double-masked, placebo-controlled, randomized study designed to evaluate the efficacy, safety and tolerability of Tinlarebant in adolescent STGD1 subjects. The phase 1b study has been completed. Approximately 60 subjects, aged 12 to 20 years old, are targeted for enrollment in the Phase 2/3 portion of the trial with a 1:1 randomization (Tinlarebant:placebo).
Tinlarebant (LBS-008) – Phase 3 trial for Stargardt Disease (the “Dragon” trial)
Recruitment Status : Active: not recruiting
The DRAGON trial is a Phase 3, randomized, placebo-controlled study of Tinlarebant to explore safety and efficacy in adolescent Stargardt disease.
Tinlarebant (LBS-008) – Phase 1b/2 trial for Stargardt Disease
Status : Completed
The Phase 1b/2 trials of Tinlarebant studied adolescent subjects with childhood-onset STGD1 disease, with the goal of the Phase 1b trial to identify the optimal dose of Tinlarebant and the goal of the Phase 2 trial to assess the safety and efficacy of Tinlarebant.