Clinical Trials
SIENNA
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.
Overview
Two experimental drugs called pozelimab and cemdisiran are being studied in this project to see how safe and effective they are as a new potential treatment for geographic atrophy (GA) caused by age-related macular degeneration (AMD).
Pozelimab and cemdisiran are experimental drugs that work in different ways to target a substance in the body called Complement Component C5 (C5), which plays a role in the immune system.
In a healthy person, C5 is involved in fighting infection in your body however in people with GA and other diseases where C5 may be involved, the actions of C5 may also lead to damage of the body’s own cells and tissues.
This study is testing if pozelimab and cemdisiran in combination or cemdisiran alone can reduce the levels and activity of C5, and therefore, slow the progression of GA.
As part of the study, suitable participants will be screened to determine their eligibility for the trial. There will be 3 treatment groups for eligible participants with an equal chance of being randomised into each group:
- pozelimab + cemdisiran combination
- cemdisiran + placebo combination
- placebo + placebo combination
Treatments will be administered as monthly subcutaneous injections over the study duration of 2 years, with the option of participating in an extension study. For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator
Professor Robyn Guymer
Two experimental drugs called pozelimab and cemdisiran are being studied in this project to see how safe and effective they are as a new potential treatment for geographic atrophy (GA) caused by age-related macular degeneration (AMD).
Pozelimab and cemdisiran are experimental drugs that work in different ways to target a substance in the body called Complement Component C5 (C5), which plays a role in the immune system.
In a healthy person, C5 is involved in fighting infection in your body however in people with GA and other diseases where C5 may be involved, the actions of C5 may also lead to damage of the body’s own cells and tissues.
This study is testing if pozelimab and cemdisiran in combination or cemdisiran alone can reduce the levels and activity of C5, and therefore, slow the progression of GA.
As part of the study, suitable participants will be screened to determine their eligibility for the trial. There will be 3 treatment groups for eligible participants with an equal chance of being randomised into each group:
- pozelimab + cemdisiran combination
- cemdisiran + placebo combination
- placebo + placebo combination
Treatments will be administered as monthly subcutaneous injections over the study duration of 2 years, with the option of participating in an extension study. For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator