Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy (PHOENIX)
Primary Purpose
Geographic Atrophy
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tinlarebant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy focused on measuring LBS-008, Tinlarebant, GA
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
Sites / Locations
- Belite Study Site
- Belite Study SiteRecruiting
- Belite Study SiteRecruiting
- Belite Study Site
- Belite Study Site
- Belite Study SiteRecruiting
- Belite Study SiteRecruiting
- Belite Study Site
- Belite Study Site
- Belite Study Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LBS-008, Tinlarebant
Placebo
Arm Description
Outcomes
Primary Outcome Measures
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
Secondary Outcome Measures
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale
To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05949593
Brief Title
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belite Bio, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy
Keywords
LBS-008, Tinlarebant, GA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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)
Allocation
Randomized
Enrollment
429 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LBS-008, Tinlarebant
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tinlarebant
Intervention Description
5 mg tablet taken orally once a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets for tinlarebant 5 mg prepared similarly.
Primary Outcome Measure Information:
Title
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
Time Frame
From baseline to Month 24]
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Belitebio Clinical Operations
Phone
+886 972 080 097
Email
clinicaltrial@belitebio.com
Facility Information:
Facility Name
Belite Study Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Belite Study Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92467
Country
United States
Individual Site Status
Recruiting
Facility Name
Belite Study Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Belite Study Site
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Belite Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Belite Study Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Belite Study Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Name
Belite Study Site
City
Strathfield
State/Province
New South Wales
ZIP/Postal Code
2135
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Belite Study Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Belite Study Site
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
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