drugset / Trial / NCT04206605

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

NCT04206605

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-05-04
Primary completion
2022-10-20
Completion
2022-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanadelumab Monoclonal antibody 300 mg Subcutaneous