Clinical Trials in the Netherlands / 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 Netherlands tracker
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
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)
- Time-normalized number of Investigator-confirmed HAE attacks — From Week 5 through Week 28
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Netherlands
Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002
Enrolling by invitation
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
Active, not recruiting
Other trials for the same condition
Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002
Enrolling by invitation
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
Active, not recruiting
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 Netherlands