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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
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)
Secondary ID [1] 0 0
LBS-008-CT05
Universal Trial Number (UTN)
Trial acronym
PHOENIX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
Timepoint [1] 0 0
From baseline to Month 24]
Secondary outcome [1] 0 0
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale
Timepoint [1] 0 0
From baseline to Month 24
Secondary outcome [2] 0 0
To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)
Timepoint [2] 0 0
From baseline to Month 24

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
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
429
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Belite Study Site - Chatswood
Recruitment hospital [2] 0 0
Belite Study Site - Strathfield
Recruitment hospital [3] 0 0
Belite Study Site - Brisbane
Recruitment hospital [4] 0 0
Belite Study Site - Adelaide
Recruitment hospital [5] 0 0
Belite Study Site - East Melbourne
Recruitment hospital [6] 0 0
Belite Study Site - Crawley
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
2135 - Strathfield
Recruitment postcode(s) [3] 0 0
4101 - Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Crawley
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Sichuan
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taichung
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taipei
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taoyuan
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Great Yarmouth
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Harrow
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Belite Bio, Inc
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05949593
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Belitebio Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
+886 972 080 097
Fax 0 0
Email 0 0
clinicaltrial@belitebio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05949593