This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

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

Sponsored by Alexion

About this trial

Last updated 2 years ago

Study ID

ALXN2040-GA-201

Status

Active, not recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
60+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

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.

What are the Participation Requirements?

Key Inclusion Criteria:

- Vaccination for Neisseria meningitidis.

- Capable of giving signed informed consent.

- Presentation of GA secondary to AMD in at least 1 eye

- The entire GA lesion must be > 1 μm outside of the foveal center

Key Exclusion Criteria:

- GA in the study eye due to cause other than AMD.

- Have previously received intravitreal anti-vascular endothelial growth factor
injections in study eye for intraocular vascular disease.

- Have previously received any stem cell/gene therapy for any ophthalmological condition
in either eye.

- Use of any investigational medicinal product (ie, participation in interventional
clinical studies for any ophthalmic indications) or use of any regulatory approved
treatment for GA in the study eye regardless of route of administration within the
last 3 months or 5 half-lives of the last dose of the investigational or commercial
product (whichever is longer).

- Presence of active ocular diseases in the study eye that in the opinion of the
Investigator compromises or confounds visual function or interferes with study
assessments.

- Known or suspected complement deficiency.

- History or presence of any medical or psychological condition that, in the opinion of
the Principal Investigator, would make the patient inappropriate for the study.

- Hypersensitivity to fluorescein sodium for injection, the investigational drug
(danicopan) or any of its excipients.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Locations

Location

Status