Trials / Active Not Recruiting
Active Not RecruitingNCT05949593
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 429 (estimated)
- Sponsor
- Belite Bio, Inc · Industry
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tinlarebant | 5 mg tablet taken orally once a day |
| DRUG | Placebo | Placebo tablets for tinlarebant 5 mg prepared similarly. |
Timeline
- Start date
- 2023-07-27
- Primary completion
- 2027-06-30
- Completion
- 2027-08-31
- First posted
- 2023-07-18
- Last updated
- 2026-01-07
Locations
49 sites across 8 countries: United States, Australia, China, Czechia, France, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05949593. Inclusion in this directory is not an endorsement.