Clinical trial NCT05949593: Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Geographic Atrophy
Keywords: LBS-008
Tinlarebant
GA
Lead sponsor: Belite Bio, Inc
Sponsor class: INDUSTRY
First posted: 2023-07-18
Enrollment: 429
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
timeFrame: From baseline to Month 24]
Secondary outcomes:
measure: To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale
timeFrame: From baseline to Month 24
measure: To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)
timeFrame: From baseline to Month 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Belite Study Site
state: Arizona
city: Arcadia
country: United States
facility: Belite Study Site
state: California
city: Beverly Hills
country: United States
facility: Belite Study Site
state: California
city: Huntington Beach
country: United States
facility: Belite Study Site
state: California
city: Los Angeles
country: United States
facility: Belite Study Site
state: California
city: Palo Alto
country: United States
facility: Belite Study Site
state: California
city: San Diego
country: United States
facility: Belite Study Site
state: California
city: Lakeland
country: United States
facility: Belite Study Site
state: Florida
city: Hagerstown
country: United States
facility: Belite Study Site
state: Maryland
city: St. Louis Park
country: United States
facility: Belite Study Site
state: Minnesota
city: Westbury
country: United States
facility: Belite Study Site
state: New York
city: Cary
country: United States
facility: Belite Study Site
state: North Carolina
city: Durham
country: United States
facility: Belite Study Site
state: North Carolina
city: Wake Forest
country: United States
facility: Belite Study Site
state: North Carolina
city: Portland
country: United States
facility: Belite Study Site
state: Oregon
city: Philadelphia
country: United States
facility: Belite Study Site
state: Pennsylvania
city: Sewickley
country: United States
facility: Belite Study Site
state: Pennsylvania
city: Germantown
country: United States
facility: Belite Study Site
state: Tennessee
city: Abilene
country: United States
facility: Belite Study Site
state: Texas
city: Dallas
country: United States
facility: Belite Study Site
state: Texas
city: San Antonio
country: United States
facility: Belite Study Site
state: Texas
city: Warrenton
country: United States
facility: Belite Study Site
state: Virginia
city: Chatswood
country: Australia
facility: Belite Study Site
state: New South Wales
city: Strathfield
country: Australia
facility: Belite Study Site
state: New South Wales
city: Brisbane
country: Australia
facility: Belite Study Site
state: Queensland
city: Adelaide
country: Australia
facility: Belite Study Site
state: South Australia
city: East Melbourne
country: Australia
facility: Belite Study Site
state: Victoria
city: Crawley
country: Australia
facility: Belite Study Site
state: Western Australia
city: Beijing
country: China
facility: Belite Study Site
state: Beijing
city: Chengdu
country: China
facility: Belite Study Site
state: Sichuan
city: Beijing
country: China
facility: Belite Study Site
city: Beijing
country: China
facility: Belite Study Site
city: Guandong
country: China
facility: Belite Study Site
city: Zhejiang
country: China
facility: Belite Study Site
city: Ostrava
country: Czech Republic
facility: Belite Study Site
city: Prague
country: Czech Republic
facility: Belite Study Site
city: Praha
country: Czech Republic
facility: Belite Study Site
city: Dijon
country: France
facility: Belite Study Site
city: Lyon
country: France
facility: Belite Study Site
city: Marseille
country: France
facility: Belite Study Site
city: Écully
country: France
facility: Belite Study Site
city: Basel
country: Switzerland
facility: Belite Study Site
city: Lausanne
country: Switzerland
facility: Belite Study Site
city: Taichung
country: Taiwan
facility: Belite Study Site
city: Taipei
country: Taiwan
facility: Belite Study Site
city: Taoyuan
country: Taiwan
facility: Belite Study Site
city: Great Yarmouth
country: United Kingdom
facility: Belite Study Site
city: Harrow
country: United Kingdom
facility: Belite Study Site
city: London
country: United Kingdom
facility: Belite Study Site
Study officials:
References: