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

Description

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

Conditions

Hereditary Angioedema

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Study Overview

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Study Details

Study overview

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

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)

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

Condition
Hereditary Angioedema
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Medical Research of Arizona, Scottsdale, Arizona, United States, 85251

Santa Monica

Raffi Tachdjian MD, Inc, Santa Monica, California, United States, 90404

Walnut Creek

Allergy & Asthma Clinical Research, Walnut Creek, California, United States, 94598

Centennial

IMMUNOe International Research Centers, Centennial, Colorado, United States, 80112

Colorado Springs

Asthma & Allergy Associates, Colorado Springs, Colorado, United States, 80907

Detriot

Henry Ford Health System, Detriot, Michigan, United States, 48202

Mineola

NYU Langone Health - Long Island, Mineola, New York, United States, 11501

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Cincinnati

Bernstein Clinical Research Center, LLC, Cincinnati, Ohio, United States, 45236

Columbus

Optimed Research, LTD, Columbus, Ohio, United States, 43235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

16 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Intellia Therapeutics,

Study Record Dates

2027-09