Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541704
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-Masked Placebo-Controlled Phase 3 Study of the Efficacy Safety and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIENNA
Brief Summary:
This study is researching experimental study drugs called pozelimab and cemdisiran The study is focused on participants who have geographic atrophy GA caused by age-related macular degeneration AMD Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision what one sees straight ahead
The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo
The study is looking at several other research questions including
What side effects may happen from taking the study drugs
How much study drugs are in the blood at different times
Whether the body makes antibodies against the study drugs which could make the study drugs less effective or could lead to side effects
The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo
The study is looking at several other research questions including
What side effects may happen from taking the study drugs
How much study drugs are in the blood at different times
Whether the body makes antibodies against the study drugs which could make the study drugs less effective or could lead to side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None