A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)

Hereditary Angioedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712228
• Other study ID #: CSL312_2001
• Secondary ID: 2018-000605-24
• Status: Completed
• Phase: Phase 2
• Start date: October 29, 2018
• Est. completion date: October 15, 2021

Study information

• Verified date: October 2022
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Biological:
• Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use

Drug:
• Placebo
Buffer without active ingredient

Locations

Country	Name	City	State
Australia	Campbelltown Hospital	Campbelltown	New South Wales
Canada	University of Alberta	Edmonton	Alberta
Canada	Allergy and Clinical Immunology McMaster University	Hamilton	Ontario
Canada	Ottawa Allergy Research Corp	Ottawa	Ontario
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Frankfurt Goethe-Universität	Frankfurt
Germany	Hautklinik und Poliklinik der Universitätsklinik Mainz	Mainz
Germany	HZRM Hämophilie Zentrum Rhein Main GmbH	Mörfelden-Walldorf
Israel	Barzilai University Medical Center	Ashkelon
United States	Immunoe Health Centers	Centennial	Colorado
United States	Institute for Asthma and Allergy	Chevy Chase	Maryland
United States	AARA Research Center	Dallas	Texas
United States	Pennsylvania State University	Hershey	Pennsylvania
United States	The Mount Sinai Hospital	New York	New York
United States	Donald S. Levy	Orange	California
United States	Allergy & Asthma Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1	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	13 weeks
Secondary	The Number of Responder Subjects With C1-INH HAE During Treatment Period 1	Response is defined as a = 50% relative reduction in the time-normalized number of HAE attacks (per month) during Treatment Period 1 compared to each subject's time-normalized number of HAE attacks (per month) during the Run-in Period	13 weeks
Secondary	The Percentage of Responder Subjects With C1-INH HAE During Treatment Period 1	Response is defined as a = 50% relative reduction in the time-normalized number of HAE attacks (per month) during Treatment Period 1 compared to each subject's time-normalized number of HAE attacks (per month) during the Run-in Period.	13 weeks
Secondary	The Number of HAE Attack-free Subjects With C1-INH HAE During Treatment Period 1		13 weeks
Secondary	The Percentage of HAE Attack-free Subjects With C1-INH HAE During Treatment Period 1		13 weeks
Secondary	The Number of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1		13 weeks
Secondary	The Percentage of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1		13 weeks
Secondary	The Mean Time-normalized Number of Mild, Moderate or Severe HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1	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	13 weeks
Secondary	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
Secondary	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
Secondary	Maximum Concentration (Cmax) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1		13 weeks
Secondary	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
Secondary	Time of Maximum Concentration (Tmax) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1		13 weeks
Secondary	Terminal Elimination Half-life (T1/2) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1		13 weeks
Secondary	Clearance (CL/F) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1		13 weeks
Secondary	Volume of Distribution During the Elimination Phase (Vz/F) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1		13 weeks
Secondary	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	Adverse events of special interest is defined as anaphylaxis, thromboembolic events, and bleeding events.	13 weeks