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Phase 3 Trial of NTLA-2002 for Hereditary Angioedema Now Recruiting

  • A Phase 3 clinical trial (NCT06634420) is actively recruiting adult participants with Hereditary Angioedema (HAE) to evaluate the efficacy and safety of NTLA-2002.
  • The study is a multinational, multicenter, double-blind, placebo-controlled trial randomizing approximately 60 participants in a 2:1 ratio to receive NTLA-2002 or placebo.
  • Participants will receive a single IV infusion of NTLA-2002 or placebo, followed by a Primary Observation Period (Week 1-28) and a Long-Term Observation Period (76 weeks), totaling 104 weeks.
  • The trial aims to assess the impact of NTLA-2002 on HAE, with a total study duration of approximately 28 months, including screening and run-in periods.
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.
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[1]
Clinical trial: Hereditary Angioedema, HAE, (NCT06634420) - CRISPR Medicine News
crisprmedicinenews.com · Nov 2, 2024

Phase 3 study evaluating NTLA-2002 efficacy & safety vs. placebo in HAE adults. Multinational, multicenter, double-blind...

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