drugset / Trial / NCT05019521
A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.
Timeline
- Start
- 2021-08-23
- Primary completion
- 2024-07-05
- Completion
- 2025-01-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Danicopan | Small molecule | 100 mg | Oral |
| Subject | Danicopan | Small molecule | 200 mg | Oral |
| Subject | Danicopan | Small molecule | 400 mg | Oral |