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ACTIVE NOT RECRUITING
NCT06634420
PHASE3

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

Sponsor: Intellia Therapeutics

View on ClinicalTrials.gov

Summary

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

Official title: 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)

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-01-15

Completion Date

2027-09

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

NTLA-2002

CRISPR/Cas9 gene editing system delivered by lipid nanoparticle (LNP) for intravenous (IV) administration

BIOLOGICAL

Normal Saline IV Administration

The administration of intravenous (IV) normal saline

Locations (29)

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

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

AARA Research Center

Dallas, Texas, United States

Campbelltown Hospital

Campbelltown, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

University of Alberta

Edmonton, Alberta, Canada

Ottawa Allergy Research Corporation

Ottawa, Ontario, Canada

CHU Grenoble-Alpes - Hopital Michallon

Grenoble, France

CHU de Lille - Hopital Claude Huriez

Lille, France

AP-HM - Hopital de la Timone

Marseille, France

Charite Universitaetsmedizin Berlin

Berlin, Germany

Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet

Frankfurt, Germany

Medizinische Hochschule Hannover (MHH)

Hanover, Germany

Amsterdam UMC - Locatie AMC

Amsterdam, Netherlands

New Zealand Clinical Research (NZCR)

Auckland, New Zealand

University of Cape Town - Lung Institute - Lung Clinical Research Unit

Cape Town, South Africa

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom