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

Sponsor

Belite Bio, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05949593

Collaborator

(none)

429

Enrollment

Locations

Arms

Anticipated Duration (Months)

214.5

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Geographic Atrophy	Drug: Tinlarebant Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

429 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

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)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Jul 31, 2023

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Nov 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LBS-008, Tinlarebant	Drug: Tinlarebant 5 mg tablet taken orally once a day
Placebo Comparator: Placebo	Drug: Placebo Placebo tablets for tinlarebant 5 mg prepared similarly.

Arm

Intervention/Treatment

Experimental: LBS-008, Tinlarebant

Drug: Tinlarebant

5 mg tablet taken orally once a day

Placebo Comparator: Placebo

Drug: Placebo

Placebo tablets for tinlarebant 5 mg prepared similarly.

Outcome Measures

Primary Outcome Measures

To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size [From baseline to Month 24]

Secondary Outcome Measures

To measure rate of change (growth rate slope) in the aggregate area of the combined hyper- plus hypoautofluorescence lesions [From baseline to Month 24]
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]
To measure changes in mean retinal thickness by SD-OCT [From baseline to Month 24]
To measure the rate of change in atrophic lesion size as determined by color fundus photography [From baseline to Month 24]
To measure morphologic changes within the retinal pigment epithelium (RPE) by SD-OCT [From baseline to Month 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Belite Study Site	Huntington Beach	California	United States	92467
2	Belite Study Site	Hagerstown	Maryland	United States	21740

Sponsors and Collaborators

Belite Bio, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Belite Bio, Inc

ClinicalTrials.gov Identifier:

NCT05949593

Other Study ID Numbers:

LBS-008-CT05

First Posted:

Jul 18, 2023

Last Update Posted:

Jul 24, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Belite Bio, Inc

LBS-008

Tinlarebant

Additional relevant MeSH terms:

Geographic Atrophy

Atrophy

Study Results

No Results Posted as of Jul 24, 2023