A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)

Summary

This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to prevent attacks in subjects with HAE.

Timeline

Start

2018-10-29

Primary completion

2021-10-15

Completion

2021-10-15

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.
• Craig TJ, Levy DS, Reshef A, Lumry WR, Martinez-Saguer I, Jacobs JS, Yang WH, Ritchie B, Aygoren-Pursun E, Keith PK, Busse P, Feuersenger H, Alexandru Bica M, Jacobs I, Pragst I, Magerl M. Garadacimab for hereditary angioedema attack prevention: long-term efficacy, quality of life, and safety data from a phase 2, randomised, open-label extension study. Lancet Haematol. 2024 Jun;11(6):e436-e447. doi: 10.1016/S2352-3026(24)00081-4. Epub 2024 May 3.
• Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
• Craig T, Magerl M, Levy DS, Reshef A, Lumry WR, Martinez-Saguer I, Jacobs JS, Yang WH, Ritchie B, Aygoren-Pursun E, Keith PK, Busse P, Feuersenger H, Pawaskar D, Jacobs I, Pragst I, Doyle MK. Prophylactic use of an anti-activated factor XII monoclonal antibody, garadacimab, for patients with C1-esterase inhibitor-deficient hereditary angioedema: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2022 Mar 5;399(10328):945-955. doi: 10.1016/S0140-6736(21)02225-X. Epub 2022 Feb 24.

Drugs

Indications