A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

NCT05469789 · tracked via the Priya Life Science UK tracker

Sponsor

Takeda

Phase

Observational

Started

2023-06-29

Last updated

2025-11-20

Condition(s) studied

Hereditary Angioedema (HAE)

Investigational drug(s) / intervention(s)

No Intervention

No Intervention: As it is an observational study, no intervention is administered in this study.

Study summary

The main aim of this study is to compare the HAE attacks (both total and those requiring on-demand treatment) in the 12 months before and up to 24 months after initiation of treatment with lanadelumab.

This study is conducted in the United Kingdom where participants were treated or about to be treated with landelumab according to their routine practice at hospitals. Data will be directly collected from participants via study diaries, questionnaires, their medical records, and study doctors treating them. Participants will be contacted every 3 months during study participation (via phone).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion: * Documented diagnosis of HAE type I or II (confirmed through laboratory testing) * Documented initiation of treatment with lanadelumab or due to be initiated within next 4 weeks * Greater than or equal to (≥)12 years of age at initiation of treatment with lanadelumab * ≥12 months of continuous medical record data before initiation of treatment with lanadelumab Exclusion: • Exposure to lanadelumab administered as an investigation product in a clinical trial setting at any point in time

Primary outcome measure(s)

Number of Hereditary Angioedema (HAE) Attacks — Up to approximately 3 years
Number of HAE attacks (both total \[including untreated\] and those requiring on-demand treatment) will be estimated across the pre- and post-treatment periods (that is, 12 months before and up to 24 months after initiation of treatment with lanadelumab).

Trial sites (1)

Facility	City	Region	Status
Barts Health NHS Trust	London	England

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Other trials for the same condition

Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE) Recruiting

A Long-Term Study of Navenibart in Participants With Hereditary Angioedema Enrolling by invitation

Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE Active, not recruiting

Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE Recruiting

A Study of Navenibart in Participants With Hereditary Angioedema Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05469789 on ClinicalTrials.gov ↗ ← All trials in the UK