CSL312 for Hereditary Angioedema

Recruiting in Palo Alto (17 mi)

+43 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: CSL Behring

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)

Eligibility Criteria

This trial is for males and females aged 12 or older with hereditary angioedema (HAE), who've had at least three HAE attacks in the past three months. Participants must not be pregnant, breastfeeding, or unwilling to use contraception. They can't have other forms of angioedema or have used certain medications like monoclonal antibodies within specific time frames before the study.

Inclusion Criteria

You have not taken the study drug CSL312 for at least 1 month before joining the trial.

I am 12 years old or older.

I have had 3 or more HAE attacks in the last 3 months.

+2 more

Exclusion Criteria

I have been diagnosed with another type of swelling condition besides HAE.

I am pregnant, breastfeeding, or not willing to stop breastfeeding.

I am fertile, sexually active, and not using or unwilling to use birth control during and 30 days after the study.

+3 more

Participant Groups

The trial is testing CSL312 (Garadacimab) given under the skin to see how safe and effective it is over a long period for preventing swelling attacks in people with hereditary angioedema—a condition causing repeated episodes of severe swelling.

1Treatment groups

Experimental Treatment

Group I: CSL312Experimental Treatment1 Intervention

Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously