CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

CSL Behring

Status and phase: Completed; Phase 3

Conditions: Hereditary Angioedema

Treatments: Biological: CSL312; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04656418

CSL312_3001

2020-000570-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Note: For subjects taking any prophylactic HAE therapy during the 3 months before Screening, ≥ 3 HAE attacks may be documented over 3 consecutive months before commencing the prophylactic therapy.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

CSL312

Experimental group

Description:

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.

Treatment:

Biological: CSL312

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo