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

• Status: Completed
• Trial end date: 2021-10-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Behring
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• Male or female

• Aged ≥ 18 to ≤ 65 years

• A diagnosis of C1-INH HAE or FXII/PLG HAE;

• For subjects with C1-INH HAE: ≥ 4 HAE attacks over a consecutive 2-month period during the 3 months before Screening, as documented in the subject's medical record.

Exclusion Criteria:

• History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic risk

• History of an uncontrolled, abnormal bleeding event due to a coagulopathy, or a current clinically significant coagulopathy or clinically significant risks for bleeding events

• Known incurable malignancies