Overview

A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

Status:
Recruiting

Trial end date:
2023-03-03

Target enrollment:

Participant gender:

Summary

The main aim of this study is to check if repeated subcutaneous (SC) injections of lanadelumab can prevent angioedema attacks in teenagers and adults with non-histaminergic angioedema with normal C1-INH. Another aim is to check if they tolerate the repeated SC injections. Participants will receive a SC injection of lanadelumab every two weeks for 26 weeks. The first two doses of lanadelumab will be given at the study clinic. Once a participant (and/or parent/caregiver) has been appropriately trained, lanadelumab can be self-injected. Visits to the study clinic are planned for the first, third and fourth week and then every 4 weeks.

Phase:

Phase 3

Details

Lead Sponsor:

Shire

Collaborator:

Takeda Development Center Americas, Inc.

Treatments:

Complement C1 Inactivator Proteins
Complement C1 Inhibitor Protein