NCT04206605

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

A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study consists of non-histaminergic normal C1-INH angioedema population with 12 years of age and above. Participants will be randomized 2:1 to receive repeated SC administrations of lanadelumab or placebo in a double-blind fashion. Randomization will be stratified based on baseline angioedema attack rate (1 to less than (\<) 2 attacks/4 weeks, and greater than (\>=) 2 attacks/4 weeks), as well as subtype (known mutations, family history and unknown mutation, idiopathic).

Conditions

• Angioedema

Interventions

Type	Name	Description
OTHER	Placebo	Placebo-matching lanadelumab SC injection.
DRUG	Lanadelumab	Lanadelumab solution in a PFS for injection.

Timeline

• Start date: 2020-05-04
• Primary completion: 2022-10-20
• Completion: 2022-10-20
• First posted: 2019-12-20
• Last updated: 2023-12-27
• Results posted: 2023-12-27

Locations

45 sites across 10 countries: United States, Canada, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study