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NCT05949593 Clinical Trial

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

Geographic Atrophy Clinical Trial

— PHOENIX  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05949593
Other study ID # LBS-008-CT05
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 27, 2023
Est. completion date November 30, 2027

Study information
Verified date March 2024
Source Belite Bio, Inc
Contact Belitebio Clinical Operations
Phone +886 972 080 097
Email clinicaltrial@belitebio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 429
Est. completion date November 30, 2027
Est. primary completion date August 31, 2027
Accepts healthy volunteers No
Gender All
Age group 60 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tinlarebant
5 mg tablet taken orally once a day
• Placebo
Placebo tablets for tinlarebant 5 mg prepared similarly.

Locations
Country Name City State
Australia Belite Study Site Adelaide South Australia
Australia Belite Study Site Brisbane Queensland
Australia Belite Study Site Chatswood New South Wales
Australia Belite Study Site Crawley Western Australia
Australia Belite Study Site East Melbourne Victoria
Australia Belite Study Site East Melbourne Victoria
Australia Belite Study Site Strathfield New South Wales
China Belite Study Site Beijing Beijing
China Belite Study Site Chengdu Sichuan
Taiwan Belite Study Site Taichung
Taiwan Belite Study Site Taipei
Taiwan Belite Study Site Taoyuan
United Kingdom Belite Study Site Great Yarmouth
United Kingdom Belite Study Site Harrow
United Kingdom Belite Study Site London
United States Belite Study Site Abilene Texas
United States Belite Study Site Arcadia California
United States Belite Study Site Beverly Hills California
United States Belite Study Site Durham North Carolina
United States Belite Study Site Germantown Tennessee
United States Belite Study Site Hagerstown Maryland
United States Belite Study Site Huntington Beach California
United States Belite Study Site Los Angeles California
United States Belite Study Site Philadelphia Pennsylvania
United States Belite Study Site Phoenix Arizona
United States Belite Study Site Portland Oregon
United States Belite Study Site San Diego California
United States Belite Study Site Sewickley Pennsylvania
United States Belite Study Site Wake Forest North Carolina
United States Belite Study Site Westbury New York

Sponsors (1)
Lead Sponsor Collaborator
Belite Bio, Inc

Countries where clinical trial is conducted

United States,  Australia,  China,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size From baseline to Month 24]
Secondary 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
Secondary 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
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