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

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 - CSL312 (garadacimab) in the prevention of hereditary angioedema attacks

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50841

Enrollment

Registered

2020-10-21

Start date

2021-04-30

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HAE Hereditary angioedema

Interventions

Subjects will be randomly assigned to receive one of the following treatments: - Group 1 CSL312 - Group 2 placebo Subjects randomized to the Active Arm will receive CSL312 SC. Subjects randomized t

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male or female * 12 years of age; diagnosed with clinically confirmed C1-INH hereditry angioedema; experience * 3 attacks during the 3 months before Screening

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the time-normalized number of HAE attacks during treatment from Day 1 through Day 182.	—

Secondary

Measure	Time frame
The secondary endpoints of the study are: * The reduction in the attack rate during the Treatment Period compared to the Run-in Period. * The time-normalized number of HAE attacks requiring on-demand treatment. * The time-normalized number of moderate and / or severe HAE attacks. * The time-normalized number of HAE attacks at various time points during the treatment period. * Subject Global Assessment of Response to Treatment (SGART). * Adverse events (AEs). * Adverse events of special interest (AESIs). * Serious adverse events (SAEs). * CSL312 induced anti-CSL312 antibodies. * Clinically significant abnormalities in laboratory assessments (ie, laboratory abnormalities reported as AEs).	—

Measure

Time frame

The secondary endpoints of the study are: * The reduction in the attack rate during the Treatment Period compared to the Run-in Period. * The time-normalized number of HAE attacks requiring on-demand treatment. * The time-normalized number of moderate and / or severe HAE attacks. * The time-normalized number of HAE attacks at various time points during the treatment period. * Subject Global Assessment of Response to Treatment (SGART). * Adverse events (AEs). * Adverse events of special interest (AESIs). * Serious adverse events (SAEs). * CSL312 induced anti-CSL312 antibodies. * Clinically significant abnormalities in laboratory assessments (ie, laboratory abnormalities reported as AEs).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)