A study to investigate CSL312 in subjects with hereditary angioedema (HAE)

A multicenter, randomized, placebo-controlled, parallel-arm study to investigate the efficacy, pharmacokinetics, and safety of CSL312 in subjects with hereditary angioedema

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000605-24-DE

Enrollment

Registered

2018-06-28

Start date

2018-12-20

Completion date

Unknown

Last updated

2021-11-15

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: Factor XIIa antagonist monoclonal antibody Current Sponso

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female - Aged = 18 to = 65 years - A diagnosis of C1-INH HAE or FXII/PLG HAE; - For subjects with C1-INH HAE: = 4 HAE attacks over a consecutive 2- month period during the 3 months before Screening, as documented in the subject's medical record. Are the trial subjects under 18? no Number of subjects for this age range: 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic risk - History of an uncontrolled, abnormal bleeding event due to a coagulopathy, or a current clinically significant coagulopathy or clinically significant risks for bleeding events - Known incurable malignancies

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to evaluate the efficacy of CSL312 in the prevention of HAE attacks in subjects with C1-INH HAE.;Secondary Objective: The secondary objectives of the study are: 1. To further evaluate the efficacy of CSL312 in subjects with C1-INH HAE 2. To evaluate the pharmacokinetics of CSL312 in subjects with C1-INH HAE 3. To evaluate the safety and tolerability of CSL312 in subjects with C1- INH HAE;Primary end point(s): Time normalized number of HAE attacks;Timepoint(s) of evaluation of this end point: 13 weeks	—

Measure

Time frame

Main Objective: The main objective is to evaluate the efficacy of CSL312 in the prevention of HAE attacks in subjects with C1-INH HAE.;Secondary Objective: The secondary objectives of the study are: 1. To further evaluate the efficacy of CSL312 in subjects with C1-INH HAE 2. To evaluate the pharmacokinetics of CSL312 in subjects with C1-INH HAE 3. To evaluate the safety and tolerability of CSL312 in subjects with C1- INH HAE;Primary end point(s): Time normalized number of HAE attacks;Timepoint(s) of evaluation of this end point: 13 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1. The number of Responder subjects and HAE attack-free subjects with C1-INH HAE during Treatment Period 1 2. The percentage of Responder subjects and HAE attack-free subjects with C1-INH HAE during Treatment Period 1 3. The number of mild, moderate or severe HAE attacks, as well as mild, moderate or severe HAE attacks treated with on-demand HAE medication, in subjects with C1-INH HAE during Treatment Period 1 4. The time-normalized number of mild, moderate or severe HAE attacks, as well as mild, moderate or severe HAE attacks treated with on-demand HAE medication, in subjects with C1-INH HAE during Treatment Period 1 5. The percentage of mild, moderate or severe HAE attacks, as well as mild, moderate or severe HAE attacks treated with on-demand HAE medication, in subjects with C1-INH HAE during Treatment Period 1 6. Maximum concentration (Cmax) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 7. Area under the concentration-time curve in 1 dosing interval (AUC0- tau) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 8. Time of maximum concentration (Tmax) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 9. Terminal elimination half-life (T1/2) of CSL312 in subjects with C1- INH HAE during Treatment Period 1 10. Total systemic clearance (CLtot) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 11 Volume of distribution during the elimination phase (Vz) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 12. The number of subjects with C1-INH HAE with adverse events, serious adverse events, adverse events of special interest, injection site reactions, inhibitory antibodies to CSL312, clinically significant abnormalities in laboratory assessment that are reported as adverse events during Treatment Period 1 13. The percentage of subjects with C1-INH HAE with adverse events, serious adverse events, adverse events of special interest, injection sit	—

Measure

Time frame

Secondary end point(s): 1. The number of Responder subjects and HAE attack-free subjects with C1-INH HAE during Treatment Period 1 2. The percentage of Responder subjects and HAE attack-free subjects with C1-INH HAE during Treatment Period 1 3. The number of mild, moderate or severe HAE attacks, as well as mild, moderate or severe HAE attacks treated with on-demand HAE medication, in subjects with C1-INH HAE during Treatment Period 1 4. The time-normalized number of mild, moderate or severe HAE attacks, as well as mild, moderate or severe HAE attacks treated with on-demand HAE medication, in subjects with C1-INH HAE during Treatment Period 1 5. The percentage of mild, moderate or severe HAE attacks, as well as mild, moderate or severe HAE attacks treated with on-demand HAE medication, in subjects with C1-INH HAE during Treatment Period 1 6. Maximum concentration (Cmax) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 7. Area under the concentration-time curve in 1 dosing interval (AUC0- tau) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 8. Time of maximum concentration (Tmax) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 9. Terminal elimination half-life (T1/2) of CSL312 in subjects with C1- INH HAE during Treatment Period 1 10. Total systemic clearance (CLtot) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 11 Volume of distribution during the elimination phase (Vz) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 12. The number of subjects with C1-INH HAE with adverse events, serious adverse events, adverse events of special interest, injection site reactions, inhibitory antibodies to CSL312, clinically significant abnormalities in laboratory assessment that are reported as adverse events during Treatment Period 1 13. The percentage of subjects with C1-INH HAE with adverse events, serious adverse events, adverse events of special interest, injection sit

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Countries

Australia, Canada, Denmark, Germany, Israel, United States

Contacts

Public ContactTrial Registration Coordinator

CSL Behring LLC

clinicaltrials@cslbehring.com+1610 878 4000

Outcome results

None listed

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