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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hereditary Angioedema

In brief

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

Key facts

Study ID

NCT06634420

Run by

Intellia Therapeutics

People needed

80

Starts

2025-01-15

Expected to finish

2027-09-01

Last updated by the study team

2026-07-29

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥16 years
• Clinical history consistent with HAE-C1INH-Type 1 or -Type 2
• Ability to provide evidence of HAE attacks (confirmed by the Investigator) to meet the screening requirement
• Must agree to refrain from the use of long-term prophylactic therapies from the start of the screening period through the end of the Primary Observation Period. PI must be in agreement that it is medically acceptable for the participant to do so.
• Must have access to, and the ability to use, on-demand medication(s) to treat potential angioedema attacks
• Adequate chemistry and hematology measures at screening
• Must agree not to participate in another interventional study for the duration of this trial.
• Must be capable of providing signed informed consent. Participants 16 to < 18 years of age, whose legal guardian provides informed consent, must provide assent.
• Must agree to follow contraception requirements

You may not qualify if…

• Concurrent diagnosis of any other type of recurrent angioedema or HAE with normal C1-INH
• Have known negative reaction or hypersensitivity to any lipid nanoparticles (LNP) component.
• Any condition that, in the Investigator's opinion, could adversely affect the safety of the subject.
• Unwilling to comply with study procedures.

Where it is running

• 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

Full record on ClinicalTrials.gov

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