Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
PHOENIX
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)
1 other identifier
interventional
429
8 countries
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2023
Typical duration for phase_3
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2023
CompletedFirst Posted
Study publicly available on registry
July 18, 2023
CompletedStudy Start
First participant enrolled
July 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
January 7, 2026
January 1, 2026
3.9 years
July 10, 2023
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
From baseline to Month 24]
Secondary Outcomes (2)
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
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
Study Arms (2)
LBS-008, Tinlarebant
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
- Minimum BCVA is required in the study eye
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Belite Bio, Inclead
Study Sites (49)
Belite Study Site
Phoenix, Arizona, 85020, United States
Belite Study Site
Arcadia, California, 91007, United States
Belite Study Site
Beverly Hills, California, 90211, United States
Belite Study Site
Huntington Beach, California, 92467, United States
Belite Study Site
Los Angeles, California, 90033, United States
Belite Study Site
Palo Alto, California, 94303, United States
Belite Study Site
San Diego, California, 92093, United States
Belite Study Site
Lakeland, Florida, 33805, United States
Belite Study Site
Hagerstown, Maryland, 21740, United States
Belite Study Site
Saint Louis Park, Minnesota, 55416, United States
Belite Study Site
Westbury, New York, 11590, United States
Belite Study Site
Cary, North Carolina, 27511, United States
Belite Study Site
Durham, North Carolina, 27710, United States
Belite Study Site
Wake Forest, North Carolina, 27587, United States
Belite Study Site
Portland, Oregon, 97239, United States
Belite Study Site
Philadelphia, Pennsylvania, 19107, United States
Belite Study Site
Sewickley, Pennsylvania, 15143, United States
Belite Study Site
Germantown, Tennessee, 38138, United States
Belite Study Site
Abilene, Texas, 79606, United States
Belite Study Site
Dallas, Texas, 75231, United States
Belite Study Site
San Antonio, Texas, 78240, United States
Belite Study Site
Warrenton, Virginia, 20186, United States
Belite Study Site
Chatswood, New South Wales, 2067, Australia
Belite Study Site
Strathfield, New South Wales, 2135, Australia
Belite Study Site
Brisbane, Queensland, 4101, Australia
Belite Study Site
Adelaide, South Australia, 5000, Australia
Belite Study Site
East Melbourne, Victoria, 3002, Australia
Belite Study Site
Crawley, Western Australia, 6009, Australia
Belite Study Site
Beijing, Beijing Municipality, 100044, China
Belite Study Site
Chengdu, Sichuan, 610093, China
Belite Study Site
Beijing, 10005, China
Belite Study Site
Beijing, 100730, China
Belite Study Site
Guandong, 510060, China
Belite Study Site
Zhejiang, 325027, China
Belite Study Site
Ostrava, 70852, Czechia
Belite Study Site
Prague, 14000, Czechia
Belite Study Site
Prague, 14059, Czechia
Belite Study Site
Dijon, 21000, France
Belite Study Site
Écully, 69130, France
Belite Study Site
Lyon, 69317, France
Belite Study Site
Marseille, 130008, France
Belite Study Site
Basel, 4031, Switzerland
Belite Study Site
Lausanne, 1001, Switzerland
Belite Study Site
Taichung, 40447, Taiwan
Belite Study Site
Taipei, 100, Taiwan
Belite Study Site
Taoyuan District, 33305, Taiwan
Belite Study Site
Great Yarmouth, NR31 6LA, United Kingdom
Belite Study Site
Harrow, HA1 3UJ, United Kingdom
Belite Study Site
London, EC1V 2PD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2023
First Posted
July 18, 2023
Study Start
July 27, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share