Clinical trial

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)

Name

LBS-008-CT05

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.

Trial arms

Trial start

2023-07-27

Estimated PCD

2027-08-31

Trial end

2027-11-30

Status

Recruiting

Phase

Early phase I

Treatment

Tinlarebant

5 mg tablet taken orally once a day

Arms:

LBS-008, Tinlarebant

Placebo

Placebo tablets for tinlarebant 5 mg prepared similarly.

Arms:

Placebo

Size

429

Primary endpoint

To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size

From baseline to Month 24]

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Eligible subjects will be randomly assigned to begin treatment in 2:1 ratio to receive the study drug (either Tinlarebant 5 mg or matching placebo)', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 429, 'type': 'ESTIMATED'}}

Updated at

2024-03-19

1 organization

2 products

1 indication

Organization

Product

Indication

Product