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

ID#: NCT06634420

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: January 15, 2025

End Date: September 01, 2027

Contact Information:
Trial Manager at Intellia Therapeutics
1-857-285-6200
Summary: This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in adult participants with HAE.
Eligibility:

Inclusion Criteria:

1. Age ≥18 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

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.
Find a Clinical Trial Find Cancer Clinical Trials