A Phase 3 clinical trial is now recruiting participants to assess the safety and efficacy of NTLA-2002 in adults with Hereditary Angioedema (HAE). The study, identified as NCT06634420, is a multinational, multicenter, double-blind, placebo-controlled trial designed to evaluate NTLA-2002 compared to a placebo. Approximately 60 participants will be randomized in a 2:1 ratio to receive a single intravenous (IV) infusion of either NTLA-2002 or a placebo.
The trial includes a Primary Observation Period from Week 1 through Week 28. Following this, participants have the option to receive a blinded, single IV infusion of the opposite treatment. After the Primary Observation Period, participants will enter a Long-Term Observation Period lasting 76 weeks, bringing the total study duration to 104 weeks. Including the Screening and Run-In Period before the first blinded dosing, the entire study spans approximately 28 months.
This Phase 3 trial represents a significant step in evaluating NTLA-2002 as a potential treatment for HAE. The double-blind, placebo-controlled design aims to provide robust data on the drug's efficacy and safety profile. The extended observation periods will allow for a comprehensive assessment of both short-term and long-term effects of NTLA-2002.
