Active — Not RecruitingPhase 1/2

NTLA-2002 in Adults With Hereditary Angioedema (HAE)

Australia, France, Germany37 participantsStarted 2021-12-10

Plain-language summary

This study will be conducted to evaluate the safety, tolerability, activity, pharmacokinetics, and pharmacodynamics of NTLA-2002 in adults with Hereditary Angioedema (HAE).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age \>18 years
✓. Diagnosis of HAE Types I or II
✓. Ability to provide evidence of HAE attacks to meet the screening requirement
✓. Subjects must have access to, and the ability to use, ≥ 1 acute medication(s) to treat angioedema attacks.
✓. Adequate chemistry and hematology measures at screening
✓. Subjects must agree not to participate in another interventional study for the duration of this trial.
✓. Subjects must be capable of providing signed informed consent

Exclusion criteria

✕. Concurrent diagnosis of any other type of recurrent angioedema
✕. Subjects who have known negative reaction or hypersensitivity to any lipid nanoparticles (LNP) component.
✕. Any condition that, in the Investigator's opinion, could adversely affect the safety of the subject.
✕. Unwilling to comply with study procedures.

What they're measuring

Safety and tolerability of NTLA-2002 as determined by adverse events (AEs) and dose limiting toxicities (DLTs)

Timeframe: From NTLA-2002 infusion up to week 104 post-infusion

Number of HAE attacks per month (Weeks 1-16)

Timeframe: From study drug infusion up to week 16 post-infusion

Trial details

NCT IDNCT05120830

SponsorIntellia Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-04

View on ClinicalTrials.gov More Hereditary Angioedema trials