Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 2
Alexion Pharmaceuticals, Inc. (Voir sur ClinicalTrials)
août 2021
août 2025
03 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Eric SOUIED | 29/03/2024 01:30:04 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Yannick Le MER | 21/06/2024 13:34:51 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 06000 - Nice - France | Contact (sur clinicalTrials) | ||||
| Research Site - 13008 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 67091 - Strasbourg Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69004 - Lyon Cedex 04 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69130 - Écully - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75019 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75571 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94010 - Creteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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.