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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05949593
Registration number
NCT05949593
Ethics application status
Date submitted
10/07/2023
Date registered
18/07/2023
Date last updated
19/03/2024
Titles & IDs
Public title
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
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Scientific 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)
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Secondary ID [1]
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LBS-008-CT05
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Universal Trial Number (UTN)
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Trial acronym
PHOENIX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tinlarebant
Treatment: Drugs - Placebo
Experimental: LBS-008, Tinlarebant -
Placebo Comparator: Placebo -
Treatment: Drugs: Tinlarebant
5 mg tablet taken orally once a day
Treatment: Drugs: Placebo
Placebo tablets for tinlarebant 5 mg prepared similarly.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
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Assessment method [1]
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Timepoint [1]
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From baseline to Month 24]
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Secondary outcome [1]
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To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale
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Assessment method [1]
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Timepoint [1]
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From baseline to Month 24
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Secondary outcome [2]
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To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)
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Assessment method [2]
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Timepoint [2]
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From baseline to Month 24
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Eligibility
Key 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
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Minimum age
60
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/11/2027
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Actual
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Sample size
Target
429
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Belite Study Site - Chatswood
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Recruitment hospital [2]
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Belite Study Site - Strathfield
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Recruitment hospital [3]
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Belite Study Site - Brisbane
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Recruitment hospital [4]
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Belite Study Site - Adelaide
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Recruitment hospital [5]
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Belite Study Site - East Melbourne
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Recruitment hospital [6]
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Belite Study Site - Crawley
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Recruitment postcode(s) [1]
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2067 - Chatswood
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Recruitment postcode(s) [2]
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2135 - Strathfield
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Recruitment postcode(s) [3]
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4101 - Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3002 - East Melbourne
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Recruitment postcode(s) [6]
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6009 - Crawley
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Maryland
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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North Carolina
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Country [6]
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United States of America
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State/province [6]
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Oregon
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Country [7]
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United States of America
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State/province [7]
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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China
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State/province [10]
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Beijing
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Country [11]
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China
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State/province [11]
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Sichuan
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Country [12]
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Taiwan
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State/province [12]
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Taichung
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Taiwan
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State/province [13]
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Taipei
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Taiwan
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State/province [14]
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Taoyuan
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Country [15]
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United Kingdom
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State/province [15]
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Great Yarmouth
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Country [16]
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United Kingdom
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State/province [16]
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Harrow
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Country [17]
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United Kingdom
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State/province [17]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Belite Bio, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05949593
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Belitebio Clinical Operations
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Address
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Country
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Phone
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+886 972 080 097
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05949593
Download to PDF