drugset / Trial / NCT05019521

A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

NCT05019521

Phase 2 Terminated 365 enrolled Alexion Pharmaceuticals, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Danicopan Small molecule 100 mg Oral
Subject Danicopan Small molecule 200 mg Oral
Subject Danicopan Small molecule 400 mg Oral