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drugset / Trial / NCT06634420

HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)

NCT06634420 ↗

Phase 3 Active not recruiting 80 enrolled Intellia Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in participants with HAE.

Timeline

Start: 2025-01-15
Primary completion: 2026-02-10
Completion: 2027-09

Publications

Cohn DM, Gurugama P, Longhurst HJ, Aygoren-Pursun E, Craig TJ, Farkas H, Jacobs J, Lumry WR, Magerl M, Peter J, Riedl MA, Maag D, Golden A, Shah MY, Sutherland A, Miller CR, Abdelhady AM, Xu Y, Butler JS, Lebwohl D, Leonard J, Banerji A; HAELO Investigators. Lonvoguran Ziclumeran - In Vivo CRISPR Gene Editing in Hereditary Angioedema. N Engl J Med. 2026 Jun 13. doi: 10.1056/NEJMoa2600931. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	NTLA-2002	CRISPR / gene editing	50 mg	Intravenous

Indications