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

NCT06634420

Active Not RecruitingPhase 3

Sponsor: Intellia Therapeutics

Conditions: Hereditary Angioedema

Interventions: NTLA-2002, Normal Saline IV Administration

Countries: United States, Australia, Canada, France, Germany, Netherlands, New Zealand, South Africa

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

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (29)
  • Scottsdale, Arizona, United States
  • San Diego, California, United States
  • Santa Monica, California, United States
  • Walnut Creek, California, United States
  • Centennial, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Tampa, Florida, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Mineola, New York, United States
  • New York, New York, United States
  • Cincinnati, Ohio, United States
  • Hershey, Pennsylvania, United States
  • Dallas, Texas, United States
  • Campbelltown, New South Wales, Australia
  • Melbourne, Victoria, Australia
  • Parkville, Victoria, Australia
  • Edmonton, Alberta, Canada
  • Ottawa, Ontario, Canada
  • Grenoble, France
  • Lille, France
  • Marseille, France
  • Berlin, Germany
  • Frankfurt, Germany
  • Hanover, Germany
  • Amsterdam, Netherlands
  • Auckland, New Zealand
  • Cape Town, South Africa
  • Cambridge, United Kingdom