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

Phase 3

Recruiting

• Conditions: Geographic Atrophy
• Interventions: Drug: Placebo; Drug: Tinlarebant

• Registration Number: NCT05949593
• Lead Sponsor: Belite Bio, Inc

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-18
• Study Start: 2023-07-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2027-08-31
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 429

Inclusion Criteria

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

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Exclusion Criteria

• The presence of diabetic macular edema or macular disease in either eye.
• Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
• Uncontrolled diagnosed glaucoma in the study eye

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
LBS-008, Tinlarebant	Tinlarebant	-

Primary Outcome Measures

Name	Time	Method
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size	From baseline to Month 24]

Secondary Outcome Measures

Name	Time	Method
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale	From baseline to Month 24
To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)	From baseline to Month 24

Trial Locations

Locations (1)

Belite Study Site; 🇬🇧 London, United Kingdom