Clinical Trials/NCT03712228

NCT03712228

Completed

Phase 2

A Multicenter, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy, Pharmacokinetics, and Safety of CSL312 in Subjects With Hereditary Angioedema

CSL Behring16 sites in 5 countries44 target enrollmentOctober 29, 2018

ConditionsHereditary Angioedema

InterventionsPlacebo Factor XIIa antagonist monoclonal antibody

DrugsPlacebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Hereditary Angioedema
Sponsor: CSL Behring
Enrollment: 44
Locations: 16
Primary Endpoint: The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to prevent attacks in subjects with HAE.

Registry

clinicaltrials.gov

Start Date

October 29, 2018

End Date

October 15, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSL Behring

Responsible Party

Sponsor

Eligibility 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.

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

Arms & Interventions

Placebo

Subjects with C1-INH HAE receiving buffer only

Intervention: Placebo

CSL312 (low)

Subjects with C1-INH HAE receiving low dose CSL312

Intervention: Factor XIIa antagonist monoclonal antibody

CSL312 (med)

Subjects with C1-INH HAE receiving medium dose CSL312

Intervention: Factor XIIa antagonist monoclonal antibody

CSL312 (high)

Subjects with C1-INH HAE receiving high dose CSL312

Intervention: Factor XIIa antagonist monoclonal antibody

CSL312 (med/high)

Subjects with C1-INH HAE receiving medium/high dose CSL312

Intervention: Factor XIIa antagonist monoclonal antibody

Outcomes

Primary Outcomes

The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1

Time Frame: 13 weeks

The time-normalized number of HAE attacks per month during Treatment Period 1 for a subject was calculated as the (number of HAE attacks / length of subject's evaluation period in days) \* 30.4375

Secondary Outcomes

The Number of Responder Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
The Percentage of Responder Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
The Number of HAE Attack-free Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
The Percentage of HAE Attack-free Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
Terminal Elimination Half-life (T1/2) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
Area Under the Concentration-time Curve in 1 Dosing Interval (AUC0-tau) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
The Percentage of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
The Number of Subjects With at Least One (1) HAE Attack Treated With On-demand HAE Medication, in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
The Percentage of Subjects With at Least One (1) HAE Attack Treated With On-demand HAE Medication, in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
Time of Maximum Concentration (Tmax) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
Volume of Distribution During the Elimination Phase (Vz/F) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
Clearance (CL/F) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
The Number of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
The Mean Time-normalized Number of Mild, Moderate or Severe HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
Maximum Concentration (Cmax) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1(13 weeks)
The Number of Subjects With C1-INH HAE With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Injection Site Reactions (ISRs), Binding Antibodies to CSL312 During Treatment Period 1(13 weeks)