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NCT05019521 · ClinicalTrials.gov registry record · Phase 2
A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 365
- Enrollment target
NCT05019521: Clinical Trial Phase 2 study, sponsored by Alexion Pharmaceuticals.
NCT05019521 is a Phase 2 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 365 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (174% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05019521, a Phase 2 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 365 participants
- Enrollment target
Study 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.
Primary Outcome
FAF provides high-contrast retinal images particularly valuable for the detection of atrophic areas. FAF images of the study eye were taken and sent to the reading center for total GA lesion area measurement. The total GA lesion area (square millimeter \[mm\^2\]) was transformed into sqrt (millimeter \[mm\]). Greater area affected means a worse outcome than smaller area affected. The rate of change from Baseline (mm/year) for each treatment group was estimated based on the coefficients for time
Interventions
- DRUG Placebo
- DRUG Danicopan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2021-08-23 |
| Est. Completion | 2025-01-21 |
| Phase | Phase 2 |
Why NCT05019521 stopped before completion
NCT05019521 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (174% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05019521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05019521 about?
NCT05019521 is a clinical study titled "A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration". 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 ...
What is the current status of trial NCT05019521?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 365 participants. The study started on 2021-08-23. Estimated completion is 2025-01-21.
What interventions are being tested in trial NCT05019521?
The interventions under investigation include: Placebo (DRUG), Danicopan (DRUG).
Who is sponsoring clinical trial NCT05019521?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05019521's enrollment target sits among peer trials
365 121st of 2000 higher than 1,880 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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