Study identifier:ALXN2040-GA-201
ClinicalTrials.gov identifier:NCT05019521
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Geographic Atrophy
Phase 2
No
Danicopan, Placebo
All
365
Interventional
60 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 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. | Drug: Danicopan Oral tablet. Other Name: ALXN2040 |
Experimental: 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. | Drug: Danicopan Oral tablet. Other Name: ALXN2040 |
Experimental: 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. | Drug: Danicopan Oral tablet. Other Name: ALXN2040 |
Placebo Comparator: 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. | Drug: Danicopan Oral tablet. Other Name: ALXN2040 Drug: Placebo Oral tablet. |