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

NCT05469789 | Active Not Recruiting

• 2 other identifiers: TAK-743-0001MACS-2021-0616012
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hereditary Angioedema (HAE)

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Number of Hereditary Angioedema (HAE) Attacks

  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).

  Up to approximately 3 years

Secondary Outcomes (16)

• Number of Participants Categorized by Their Demographic Characteristics

  At index (lanadelumab treatment initiation day)

• Number of Participants Categorized by Their Clinical Characteristics

  Up to approximately 3 years

• Number of Participants Categorized by Their Treatment Patterns

  At and after index (lanadelumab treatment initiation day plus approximately 2 years)

• Number of Participants Categorized by Their Patterns of Prophylactic Treatment

  Up to approximately 3 years

• Compare the Number of Participants Categorized by Their Clinical Features of HAE Attacks Before and After Initiation of Lanadelumab

  Up to approximately 3 years

Study Arms (3)

Prevalent Cohort A

Prevalent Cohort A will comprise eligible participants with HAE type I or II who have initiated treatment with lanadelumab at any point in time (i.e., all prevalent cases of exposure to lanadelumab). The total follow-up encompasses a 12-month pre-treatment period, and an up-to 24-month post-treatment period.

Other: No Intervention

Prevalent Cohort B

Prevalent Cohort B will comprise eligible participants with HAE type I or II who have been treated with lanadelumab for \<12 months (i.e., the subset of participants from Prevalent Cohort A who initiated treatment with lanadelumab within \<12 months). The total follow-up encompasses a 12-month pre-treatment and an up to 24-month post-treatment period, as well as a prospective data collection period of participant-specific duration.

Other: No Intervention

Incident Cohort A

Incident Cohort A will comprise eligible participants with HAE type I or II initiating treatment with lanadelumab at any time within the prospective data collection time period. The total follow-up encompasses a 12-month pre-treatment and an up-to 24-month post-treatment period, as well as a prospective data collection period of participant-specific duration.

Other: No Intervention

Interventions

No Intervention OTHER

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

Incident Cohort A; Prevalent Cohort A; Prevalent Cohort B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population of this survey is all participants with HAE type I or II treated with lanadelumab in hospitals within the UK.

You may qualify if:

• 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

You may not qualify if:

• Exposure to lanadelumab administered as an investigation product in a clinical trial setting at any point in time

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Barts Health NHS Trust

London, England, E1 1BB, United Kingdom

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: June 29, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

GB (1)