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A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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)

NCT05019521•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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

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.

Locations (128)

Research Site

Phoenix, Arizona, United States

Research Site

Beverly Hills, California, United States

Research Site

Encino, California, United States

Research Site

Fresno, California, United States

Research Site

Fullerton, California, United States

Research Site

La Jolla, California, United States

Research Site

Pasadena, California, United States

Research Site

Sacramento, California, United States

Research Site

San Mateo, California, United States

Research Site

Walnut Creek, California, United States

Key Dates

Start Date

August 23, 2021

Primary Completion Date

July 5, 2024

Completion Date

January 21, 2025

Last Updated

September 5, 2025

Enrollment

365

ACTUAL participants

Conditions

Geographic Atrophy

Interventions

Danicopan

DRUG

Placebo

DRUG

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

NCT06779773

Geographic AtrophyMacular Degeneration

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RECRUITINGPHASE2

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

NCT06990269

Geographic Atrophy Secondary to Age-related Macular Degeneration

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy