NCT04739059

Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks

An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
BIOLOGICAL	CSL312	Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody

Timeline

• Start date: 2021-04-29
• Primary completion: 2025-11-21
• Completion: 2025-11-21
• First posted: 2021-02-04
• Last updated: 2026-01-26

Locations

44 sites across 14 countries: United States, Australia, Canada, Czechia, Germany, Hong Kong, Hungary, Israel, Japan, Netherlands, New Zealand, Russia, Spain, Taiwan

Regulatory

• FDA-regulated drug study