ILLUMINATE-A is a Phase 3, “randomized, double-blind, placebo-controlled study.” What does that mean?
During the first 6 months of the study two-thirds of the participants will be randomly assigned to receive the investigational medication, lumasiran (ALN-GO1), and the remaining one-third will receive placebo (a substance with no active medicine). The groups are “randomized,” meaning they are assigned at random, and “double-blind” means neither the researchers nor the participants will know which group a participant has been assigned to until after placebo dosing is complete. Finally, although a placebo is used in the study (“placebo-controlled”), it’s important to note that all participants will receive the investigational medication starting at month 6 of the trial.
The ILLUMINATE-A study is designed to study the safety and effectiveness of lumasiran (ALN-GO1) in children and adults with Primary Hyperoxaluria Type 1 (PH1).