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NCT Number: NCT05949593

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Belite Study Site, Chatswood, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tinlarebant

Drug

5 mg tablet taken orally once a day

Placebo

Drug

Placebo tablets for tinlarebant 5 mg prepared similarly.

Primary outcomes

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

    Time frame: From baseline to Month 24]

Secondary outcomes

  1. To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale

    Time frame: From baseline to Month 24

  2. To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)

    Time frame: From baseline to Month 24

Sponsors and collaborators

Lead sponsor

Belite Bio, Inc

Industry

Registry information

Official study 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)

Acronym: PHOENIX

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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