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Clinical Trials in the UK / NCT06634420
Active, not recruiting Phase 3

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

NCT06634420 · tracked via the Priya Life Science UK tracker
Sponsor
Intellia Therapeutics
Phase
Phase 3
Started
2025-01-15
Last updated
2026-07-29

Condition(s) studied

Hereditary Angioedema

Investigational drug(s) / intervention(s)

NTLA-2002Normal Saline IV Administration

NTLA-2002: CRISPR/Cas9 gene editing system delivered by lipid nanoparticle (LNP) for intravenous (IV) administration

Normal Saline IV Administration: The administration of intravenous (IV) normal saline

Study summary

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

Eligibility

Sex
ALL
Min age
16 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥16 years 2. Clinical history consistent with HAE-C1INH-Type 1 or -Type 2 3. Ability to provide evidence of HAE attacks (confirmed by the Investigator) to meet the screening requirement 4. 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. 5. Must have access to, and the ability to use, on-demand medication(s) to treat potential angioedema attacks 6. Adequate chemistry and hematology measures at screening 7. Must agree not to participate in another interventional study for the duration of this trial. 8. Must be capable of providing signed informed consent. Participants 16 to \< 18 years of age, whose legal guardian provides informed consent, must provide assent. 9. Must agree to follow contraception requirements Exclusion Criteria: 1. Concurrent diagnosis of any other type of recurrent angioedema or HAE with normal C1-INH 2. Have known negative reaction or hypersensitivity to any lipid nanoparticles (LNP) component. 3. Any condition that, in the Investigator's opinion, could adversely affect the safety of the subject. 4. Unwilling to comply with study procedures.

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
Medical Research of Arizona Scottsdale Arizona
University of California, San Diego (UCSD) San Diego California
Raffi Tachdjian MD, Inc Santa Monica California
Allergy & Asthma Clinical Research Walnut Creek California
IMMUNOe International Research Centers Centennial Colorado
Asthma & Allergy Associates Colorado Springs Colorado
University of South Florida Tampa Florida
Massachusetts General Hospital Boston Massachusetts
Washington University in St. Louis St Louis Missouri
NYU Langone Health - Long Island Mineola New York
Icahn School of Medicine at Mount Sinai New York New York
Bernstein Clinical Research Center, LLC Cincinnati Ohio
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
AARA Research Center Dallas Texas
Campbelltown Hospital Campbelltown New South Wales
The Alfred Hospital Melbourne Victoria
Royal Melbourne Hospital Parkville Victoria
University of Alberta Edmonton Alberta
Ottawa Allergy Research Corporation Ottawa Ontario
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

More Intellia Therapeutics trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06634420 on ClinicalTrials.gov ↗ ← All trials in the UK