drugset / Trial / NCT05244304
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1
Timeline
- Start
- 2022-03-28
- Primary completion
- 2025-08-04
- Completion
- 2025-09-12
Outcome
Met primary endpoint
release “NMPA’s response is based on the interim analysis results showing statistical significance in the primary endpoint of the Phase 3 DRAGON trial.” belitebio.com ↗
release “having met the primary endpoint in the pivotal, global Phase 3 DRAGON trial” belitebio.com ↗
release “The Company has completed a Phase 3 trial (DRAGON) in adolescent and adult subjects with STGD1, which met its primary endpoint” belitebio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tinlarebant | Small molecule | 5 mg | Oral |