CSL312 (garadacimab) in the prevention of hereditary angioedema attacks

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000570-25-DE

Enrollment

Registered

2020-09-08

Start date

2021-02-09

Completion date

Unknown

Last updated

2022-08-08

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

Conditions

Hereditary angioedema MedDRA version: 23.1 Level: PT Classification code 10019860 Term: Hereditary angioedema System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Product Name: Factor XIIa antagonist monoclonal antibody Product Code: CSL312 Pharmaceutical Form: Solution for injection INN or Proposed INN: FXIIa inhibitor monoclonal antibody Current Sponsor code:

Eligibility

Sex/Gender

All

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 Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

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
Main Objective: The main objective is to evaluate the efficacy of sucutaneous administration of CSL312 as prophylaxis to prevent hereditary angioedema attacks in subjects with hereditry angioedema ;Secondary Objective: The secondary objectives of the study are: 1. To characterize the clinical efficacy of subcutaneous CSL312 in the prophylactic treatment of hereditary angioedema 2. to evaluate the safety of subcutaneous CSL312 in the prophylactic treatment of hereditary angioedema ;Primary end point(s): Time-normalized number of hereditary angioedema (HAE) attacks during treatment period ;Timepoint(s) of evaluation of this end point: up to 6 months	—

Measure

Time frame

Main Objective: The main objective is to evaluate the efficacy of sucutaneous administration of CSL312 as prophylaxis to prevent hereditary angioedema attacks in subjects with hereditry angioedema ;Secondary Objective: The secondary objectives of the study are: 1. To characterize the clinical efficacy of subcutaneous CSL312 in the prophylactic treatment of hereditary angioedema 2. to evaluate the safety of subcutaneous CSL312 in the prophylactic treatment of hereditary angioedema ;Primary end point(s): Time-normalized number of hereditary angioedema (HAE) attacks during treatment period ;Timepoint(s) of evaluation of this end point: up to 6 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. Reduction in the HAE attack rate during the treatment period compared to the run-in period 2. Time-normalized number of attacks requiring on-demand Treatment 3. Time-normalized number of moderate and/or severe HAE attacks 4. Time-normalized number of HAE attacks at various timepoints during the treatment period 5. Percent reduction in the time-normalized number of HAE attacks between CSL312 and Placebo 6. Subject's Global Assessment of Response to Therapy (SGART) 7. Number of subjects with adverse events, adverse events of special interest, serious adverse events, CSL312-induced anti-CSL312 antibodies, clinically significant abnormalities in laboratory assessments 8. Percent of subjects with Adverse events, adverse events of special interest, serious adverse events, CSL312-induced anti-CSL312 antibodies, clinically significant abnormalities in laboratory assessments ;Timepoint(s) of evaluation of this end point: to 1: up to 6 months to 2: 6 months, and first 3 months and second 3 months to 3: 6 months, and first 3 months and second 3 months to 4: First 3 months and second 3 months and 6 months to 5: 6 months, and first 3 months and second 3 months to 6: Up to 6 months to 7 and 8: Up to 8 months	—

Measure

Time frame

Secondary end point(s): 1. Reduction in the HAE attack rate during the treatment period compared to the run-in period 2. Time-normalized number of attacks requiring on-demand Treatment 3. Time-normalized number of moderate and/or severe HAE attacks 4. Time-normalized number of HAE attacks at various timepoints during the treatment period 5. Percent reduction in the time-normalized number of HAE attacks between CSL312 and Placebo 6. Subject's Global Assessment of Response to Therapy (SGART) 7. Number of subjects with adverse events, adverse events of special interest, serious adverse events, CSL312-induced anti-CSL312 antibodies, clinically significant abnormalities in laboratory assessments 8. Percent of subjects with Adverse events, adverse events of special interest, serious adverse events, CSL312-induced anti-CSL312 antibodies, clinically significant abnormalities in laboratory assessments ;Timepoint(s) of evaluation of this end point: to 1: up to 6 months to 2: 6 months, and first 3 months and second 3 months to 3: 6 months, and first 3 months and second 3 months to 4: First 3 months and second 3 months and 6 months to 5: 6 months, and first 3 months and second 3 months to 6: Up to 6 months to 7 and 8: Up to 8 months

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Countries

Canada, Germany, Hungary, Israel, Italy, Netherlands, Spain, United States

Contacts

Public ContactTrial Registration Coordinator

CSL Behring LLC

clinicaltrials@cslbehring.com+16108784000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026