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

Summary

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

Timeline

Start

2021-03-29

Primary completion

2025-11-21

Completion

2025-11-21

Publications

• Craig TJ, Guilarte M, Li HH, Anderson J, Martinez Saguer I, Jacobs JS, Tachdjian R, Farkas H, Yang WH, Ohsawa I, Hakl R, Pollen M, Pragst I, Lawo JP, Shetty H, Nenci C, Magerl M. Long-Term Integrated Safety and Efficacy of Garadacimab for Hereditary Angioedema Prophylaxis. Adv Ther. 2026 Jun 10. doi: 10.1007/s12325-026-03628-x. Online ahead of print.
• Guilarte M, Lumry WR, Magerl M, Martinez Saguer I, Reshef A, Sobotkova M, Braverman J, Lawo JP, Wieman L, Nenci C, Katelaris CH. Garadacimab improves long-term health-related quality of life in patients with hereditary angioedema. Allergy Asthma Proc. 2025 May 1;46(3):192-199. doi: 10.2500/aap.2025.46.250027.
• Staubach P, Craig TJ, Fukuda T, Aygoren-Pursun E, Hakl R, Braverman J, Lawo JP, Pollen M, Nenci C, Li PH, Farkas H. Becoming attack-free further improves health-related quality of life in patients with hereditary angioedema receiving garadacimab. Allergy Asthma Proc. 2025 May 1;46(3):200-208. doi: 10.2500/aap.2025.46.250026.

Drugs

Indications