Overview

CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

Status:
Active, not recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
Summary
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CSL Behring
Treatments:
Antibodies, Monoclonal
Criteria
Inclusion Criteria:

- Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH
hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening

Exclusion Criteria:

- Concomitant diagnosis of another form of angioedema such as idiopathic or acquired
angioedema, recurrent angioedema associated with urticarial or hereditary angioedema
type 3