CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: CSL Behring

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Study Director

Principal Investigator

CSL Behring LLC

Eligibility Criteria

Inclusion Criteria

If you have been taking HAE prophylactic therapy in the last 3 months, you must document at least 3 attacks over a consecutive period of time before beginning treatment.

You are a male or female aged 12 years old or older, diagnosed with clinically confirmed C1-INH hereditary angioedema and have experienced at least 3 attacks in the preceding 3 months.

You are a male or female aged 12 and above, diagnosed with clinically confirmed C1-INH hereditary angioedema, and have experienced at least 3 attacks in the past three months.

Treatment Details

Interventions

CSL312 (Garadacimab) (Monoclonal Antibodies)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CSL312Experimental Treatment1 Intervention

Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg subcutaneous (SC) injections, once monthly from Months 2 to 6.

Group II: PlaceboPlacebo Group1 Intervention

Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.