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

Inclusion Criteria:

• • Males and females aged ≥ 12 years
• • Diagnosed with clinically confirmed C1-INH HAE
• • Experienced ≥ 3 HAE attacks during the 3 months before Screening
• • Participated in the Run-in Period for at least 1 month (CSL312-naïve subjectsonly)
• • Experienced at least an average of 1 HAE attack per month during the Run-in Period

Exclusion Criteria:

• • Concomitant diagnosis of another form of angioedema, such as idiopathic oracquired angioedema or recurrent angioedema associated with urticaria
• • Use of C1-INH products, androgens, antifibrinolytics or other small moleculemedications for routine prophylaxis against HAE attacks at least 2 weeks before thefirst day of the Run-in Period
• • Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before thefirst day of the Run-in Period.
• • Female subjects use estrogen-containing oral contraceptives or hormone replacementtherapy within 4 weeks prior to screening
• • Female or male subjects who are fertile and sexually active not using or notwilling to use an acceptable method of contraception to avoid pregnancy during thestudy and for 30 days after receipt of the last dose of CSL312
• • Pregnant, breastfeeding, or not willing to cease breastfeeding