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

Belite Bio

Status and phase: Enrolling; Phase 3

Conditions: Geographic Atrophy

Treatments: Drug: Placebo; Drug: Tinlarebant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05949593

LBS-008-CT05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 429 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

429 participants in 2 patient groups, including a placebo group

LBS-008, Tinlarebant

Experimental group

Treatment:

Drug: Tinlarebant

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo