Trials / Terminated
TerminatedNCT05019521
A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 365 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Danicopan | Oral tablet. |
| DRUG | Placebo | Oral tablet. |
Timeline
- Start date
- 2021-08-23
- Primary completion
- 2024-07-05
- Completion
- 2025-01-21
- First posted
- 2021-08-25
- Last updated
- 2025-09-05
- Results posted
- 2025-09-05
Locations
128 sites across 13 countries: United States, Australia, Czechia, France, Germany, Hungary, Italy, Japan, Latvia, Slovakia, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05019521. Inclusion in this directory is not an endorsement.