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

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ClinicalTrials.gov Identifier: NCT05949593
Recruitment Status : Recruiting
First Posted : July 18, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Belite Bio, Inc

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Actual Study Start Date : July 27, 2023
Estimated Primary Completion Date : August 31, 2027
Estimated Study Completion Date : November 30, 2027
Arms and Interventions
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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
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Primary Outcome Measures :
  1. To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size [ Time Frame: From baseline to Month 24] ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05949593


Contacts
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Contact: Belitebio Clinical Operations +886 972 080 097 clinicaltrial@belitebio.com

Locations
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United States, California
Belite Study Site Not yet recruiting
Arcadia, California, United States, 91007
Belite Study Site Recruiting
Huntington Beach, California, United States, 92467
United States, Maryland
Belite Study Site Recruiting
Hagerstown, Maryland, United States, 21740
United States, New York
Belite Study Site Not yet recruiting
Westbury, New York, United States, 11590
United States, Oregon
Belite Study Site Not yet recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Belite Study Site Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Belite Study Site Recruiting
Abilene, Texas, United States, 79606
Australia, New South Wales
Belite Study Site Not yet recruiting
Strathfield, New South Wales, Australia, 2135
Taiwan
Belite Study Site Not yet recruiting
Taichung, Taiwan, 40447
Belite Study Site Not yet recruiting
Taoyuan, Taiwan, 33305
Sponsors and Collaborators
Belite Bio, Inc
More Information
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Responsible Party: Belite Bio, Inc
ClinicalTrials.gov Identifier: NCT05949593    
Other Study ID Numbers: LBS-008-CT05
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belite Bio, Inc:
LBS-008
Tinlarebant
GA
Additional relevant MeSH terms:
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Geographic Atrophy
Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases