A new clinical trial testing the effect of lanadelumab in teenagers and adults with hereditary angioedema (HAE) is now open. 

The observational study will compare the rate of HAE attacks that require on-demand treatment before and within 2 years of lanadelumab treatment.

The trial, sponsored by Takeda aims to recruit an estimated 50 participants at Barts Health NHS Trust in London, England with HAE types 1 or 2, aged 12 years or older who were treated or about to be treated with lanadelumab according to their routine practice at hospitals.


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Investigators will directly collect data from participants using study diaries, questionnaires, medical records, and doctors. They will contact participants by phone every 3 months.

Read more about the clinical features of HAE

The primary outcome measure of the study is the number of HAE attacks requiring on-demand treatment. Secondary outcome measures include the number of participants categorized by their demographic and clinical characteristics and treatment patterns. The number of self-reported HAE attacks, quality of life, healthcare resource utilization, and treatment satisfaction will also be assessed.

The trial is not yet recruiting participants. It is estimated to start on August 15, 2022, and be completed on October 30, 2025.

HAE is caused by a deficiency of the C1 inhibitor, which is a member of the serpin family of serine proteases. It normally works by inhibiting complement proteases, contact proteases including plasma kallikrein, and coagulation factors, thereby fulfilling an important role in regulating the complement, contact, and coagulation cascades.

Lanadelumab is a fully human IgG1 monoclonal antibody that works by inhibiting plasma kallikrein, thereby preventing swelling attacks in patients with HAE. It is approved by the US Food and Drug Administration to treat patients, aged 12 years and older.

Reference

A study of lanadelumab in teenagers and adults with hereditary angioedema (HAE). US National Library of Medicine. Updated July 22, 2022. Accessed July 29, 2022.