Alnylam initiates ILLUMINATE-C phase III study of lumasiran for the treatment of advanced primary hyperoxaluria type 1.

Alnylam Pharmaceuticals, Inc. announced that the Company has initiated ILLUMINATE-C, a new global Phase III study of lumasiran, an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of primary hyperoxaluria type 1 (PH1). The study will enroll patients of all ages with advanced renal disease, and the primary study endpoint is the percent reduction in plasma oxalate from baseline to six months. Alnylam expects to report initial ILLUMINATE-C results in late 2020. .

About ILLUMINATE-C Phase III Study : The ILLUMINATE-C Phase III trial is a single-arm, open-label, global, multicenter study to evaluate the efficacy and safety of lumasiran in approximately 16 patients with a documented diagnosis of PH1. Cohort A will enroll patients with advanced disease who do not yet require dialysis and Cohort B will enroll patients who are dialysis-dependent. During the 6-month primary analysis period patients will receive three monthly doses of lumasiran followed by monthly or quarterly maintenance doses. The primary endpoint is the percentage change in plasma oxalate from baseline to six months. Key secondary endpoints will evaluate additional measures of plasma oxalate and changes in: urinary oxalate, renal function, nephrocalcinosis, frequency and mode of dialysis, frequency of renal stone events, and measures of systemic oxalosis. For more information on ILLUMINATE-C (NCT04152200) please visit clinicaltrials.gov.