A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT ID: NCT05019521
Last Updated: 2025-09-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
365 participants
INTERVENTIONAL
2021-08-23
2025-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Danicopan: 100 mg
Participants will receive danicopan 100 mg bid during the masked Treatment Period. Once the optimal dose is identified, participants who have at least 52 weeks of treatment will be switched to the optimal dose for the remainder of the study.
Danicopan
Oral tablet.
Danicopan: 200 mg
Participants will receive danicopan 200 mg bid during the masked Treatment Period. Once the optimal dose is identified, participants who have at least 52 weeks of treatment will be switched to the optimal dose for the remainder of the study.
Danicopan
Oral tablet.
Danicopan: 400 mg
Participants will receive danicopan 400 mg qd during the masked Treatment Period. Once the optimal dose is identified, participants who have at least 52 weeks of treatment will be switched to the optimal dose for the remainder of the study.
Danicopan
Oral tablet.
Placebo
Participants will receive matching placebo and will be re-randomized to one of the active treatment groups at Week 52, or to the optimal dose, if already identified.
Danicopan
Oral tablet.
Placebo
Oral tablet.
Interventions
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Danicopan
Oral tablet.
Placebo
Oral tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Phoenix, Arizona, United States
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Beverly Hills, California, United States
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Encino, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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Pasadena, California, United States
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Sacramento, California, United States
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San Mateo, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Longmont, Colorado, United States
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Waterford, Connecticut, United States
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Clearwater, Florida, United States
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Coral Springs, Florida, United States
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Deerfield Beach, Florida, United States
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Naples, Florida, United States
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Palm Beach Gardens, Florida, United States
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St. Petersburg, Florida, United States
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Augusta, Georgia, United States
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New Albany, Indiana, United States
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West Des Moines, Iowa, United States
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Hagerstown, Maryland, United States
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Rosedale, Maryland, United States
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Towson, Maryland, United States
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Springfield, Massachusetts, United States
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Southaven, Mississippi, United States
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Reno, Nevada, United States
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Teaneck, New Jersey, United States
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Great Neck, New York, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Portland, Oregon, United States
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Springfield, Oregon, United States
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Kingston, Pennsylvania, United States
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Monroeville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Greenville, South Carolina, United States
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Ladson, South Carolina, United States
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Rapid City, South Dakota, United States
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Austin, Texas, United States
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Bellaire, Texas, United States
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Conroe, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
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Fairfax, Virginia, United States
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Lynchburg, Virginia, United States
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Adelaide, , Australia
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Albury, , Australia
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East Melbourne, , Australia
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Hurstville, , Australia
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Parramatta, , Australia
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Strathfield, , Australia
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Sydney, , Australia
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Pardubice, , Czechia
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Prague, , Czechia
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Créteil, , France
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Écully, , France
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Lyon, , France
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Marseille, , France
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Nantes, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Poitiers, , France
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Strasbourg, , France
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Berlin, , Germany
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Bonn, , Germany
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Düsseldorf, , Germany
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Freiburg im Breisgau, , Germany
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Göttingen, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Mainz A. Rhein, , Germany
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Marburg, , Germany
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München, , Germany
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Münster, , Germany
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Münster, , Germany
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Neubrandenburg, , Germany
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Regensburg, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Würzburg, , Germany
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Budapest, , Hungary
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Pécs, , Hungary
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Florence, , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Naples, , Italy
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Roma, , Italy
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Roma, , Italy
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Fukushima, , Japan
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Kita-gun, , Japan
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Osaka, , Japan
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Riga, , Latvia
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Riga, , Latvia
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Bratislava, , Slovakia
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Žilina, , Slovakia
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Busan, , South Korea
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Daegu, , South Korea
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Incheon, , South Korea
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Jinju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Bilbao, , Spain
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Córdoba, , Spain
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Majadahonda, , Spain
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Pamplona, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Zaragoza, , Spain
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Bristol, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Southampton, , United Kingdom
Countries
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References
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Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2021-001198-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALXN2040-GA-201
Identifier Type: -
Identifier Source: org_study_id
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