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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515741-42-00

Acronym

ITL-2002-CL-301

Enrollment

Registered

2025-02-24

Start date

2025-03-28

Completion date

Unknown

Last updated

2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hereditary angioedema due to C1 esterase inhibitor deficiency (Type 1 or 2)

Brief summary

Time-normalized number of Investigator-confirmed HAE attacks from Week 5 through Week 28

Detailed description

Time-normalized number of Investigator- confirmed HAE attacks requiring on-demand treatment from Week 5 through Week 28, Time-normalized number of moderate or severe Investigator-confirmed HAE attacks from Week 5 through Week 28, Investigator-confirmed HAE attack-free status from Week 5 through Week 28, Change from baseline to Week 28 in AE-QoL Questionnaire total score

Interventions

DRUGSODIUM CHLORIDE

DRUGNTLA-2002

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time-normalized number of Investigator-confirmed HAE attacks from Week 5 through Week 28	—

Secondary

Measure	Time frame
Time-normalized number of Investigator- confirmed HAE attacks requiring on-demand treatment from Week 5 through Week 28, Time-normalized number of moderate or severe Investigator-confirmed HAE attacks from Week 5 through Week 28, Investigator-confirmed HAE attack-free status from Week 5 through Week 28, Change from baseline to Week 28 in AE-QoL Questionnaire total score	—

Countries

France, Germany, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026