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

March 17, 2024 updated by: Belite Bio, Inc

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

429

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Chatswood, New South Wales, Australia, 2067
        • Recruiting
        • Belite Study Site
      • Strathfield, New South Wales, Australia, 2135
        • Recruiting
        • Belite Study Site
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Belite Study Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Belite Study Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Belite Study Site
      • East Melbourne, Victoria, Australia, 3002
        • Not yet recruiting
        • Belite Study Site
    • Western Australia
      • Crawley, Western Australia, Australia, 6009
        • Recruiting
        • Belite Study Site
  • China
    • Beijing
      • Beijing, Beijing, China, 100089
        • Not yet recruiting
        • Belite Study Site
    • Sichuan
      • Chengdu, Sichuan, China, 610093
        • Not yet recruiting
        • Belite Study Site
  • Taiwan
      • Taichung, Taiwan, 40447
        • Not yet recruiting
        • Belite Study Site
      • Taipei, Taiwan, 100
        • Recruiting
        • Belite Study Site
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Belite Study Site
  • United Kingdom
      • Great Yarmouth, United Kingdom, NR31 6LA
        • Not yet recruiting
        • Belite Study Site
      • Harrow, United Kingdom, HA1 3UJ
        • Recruiting
        • Belite Study Site
      • London, United Kingdom, EC1V 2PD
        • Not yet recruiting
        • Belite Study Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Recruiting
        • Belite Study Site
    • California
      • Arcadia, California, United States, 91007
        • Not yet recruiting
        • Belite Study Site
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Belite Study Site
      • Huntington Beach, California, United States, 92467
        • Recruiting
        • Belite Study Site
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Belite Study Site
      • San Diego, California, United States, 92093
        • Recruiting
        • Belite Study Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Belite Study Site
    • New York
      • Westbury, New York, United States, 11590
        • Recruiting
        • Belite Study Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Belite Study Site
      • Wake Forest, North Carolina, United States, 27587
        • Recruiting
        • Belite Study Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Belite Study Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Belite Study Site
      • Sewickley, Pennsylvania, United States, 15143
        • Recruiting
        • Belite Study Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Belite Study Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Belite Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
Time Frame: From baseline to Month 24]
From baseline to Month 24]

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: From baseline to Month 24
From baseline to Month 24

Other Outcome Measures

Outcome Measure
Time Frame
To evaluate the correlation between the reduction of serum RBP4 and the growth of atrophic lesions (DDAF)
Time Frame: From baseline to Month 24
From baseline to Month 24
To measure changes in retinal sensitivity as assessed by microperimetry
Time Frame: From baseline to Month 24
From baseline to Month 24
To measure changes in contrast sensitivity as assessed using the Pelli-Robson Contrast Sensitivity Chart (or any assessment deemed acceptable by study sites)
Time Frame: From baseline to Month 24
From baseline to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belite Bio, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBS-008-CT05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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