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HAELO: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2002 in Participants With Hereditary Angioedema (HAE)
This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in participants with HAE.
This is a multinational, multicenter, double-blind, placebo-controlled study in which approximately 60 participants will be randomized in a 2:1 ratio to receive a single IV infusion of NTLA-2002 or placebo. After the Primary Observation Period (Week 1 through Week 28), participants will have the option to receive a blinded, single IV infusion of the opposite treatment. Following the Primary Observation Period, participants will enter the Long-Term Observation Period (76 weeks), for a total of 104 weeks. Including the Screening and Run-In Period, prior to the first blinded dosing, the total study duration is approximately 28 months.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
Medical Research of Arizona
Scottsdale, Arizona, United States
University of California, San Diego (UCSD)
San Diego, California, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
IMMUNOe International Research Centers
Centennial, Colorado, United States
Asthma & Allergy Associates
Colorado Springs, Colorado, United States
University of South Florida
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University in St. Louis
St Louis, Missouri, United States
NYU Langone Health - Long Island
Mineola, New York, United States
Start Date
January 15, 2025
Primary Completion Date
April 1, 2026
Completion Date
September 1, 2027
Last Updated
December 18, 2025
60
ESTIMATED participants
NTLA-2002
BIOLOGICAL
Normal Saline IV Administration
BIOLOGICAL
Lead Sponsor
Intellia Therapeutics
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06842823