Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03712228
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Biological: Factor XIIa antagonist monoclonal antibody Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects are assigned to 1 of 2 or more groups in parallel for the duration of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy, Pharmacokinetics, and Safety of CSL312 in Subjects With Hereditary Angioedema
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects with C1-INH HAE receiving buffer only
Drug: Placebo
Buffer without active ingredient

Active Comparator: CSL312 (low)
Subjects with C1-INH HAE receiving low dose CSL312
Biological: Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Other Name: CSL312

Active Comparator: CSL312 (med)
Subjects with C1-INH HAE receiving medium dose CSL312
Biological: Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Other Name: CSL312

Active Comparator: CSL312 (high)
Subjects with C1-INH HAE receiving high dose CSL312
Biological: Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Other Name: CSL312

Active Comparator: CSL312 (med/high)
Subjects with C1-INH HAE receiving medium/high dose CSL312
Biological: Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Other Name: CSL312

Active Comparator: CSL312-F
Subjects with FXII or plasminogen mutation (FXII/PLG) HAE receiving CSL312
Biological: Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Other Name: CSL312




Primary Outcome Measures :
  1. Time normalized number of HAE attacks [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. The number of responder subjects and HAE attack-free subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
    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

  2. The percentage of responder subjects and HAE attack-free subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
    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.

  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 [ Time Frame: 13 weeks ]
  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 [ Time Frame: 13 weeks ]
  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 [ Time Frame: 13 weeks ]
  6. Maximum concentration (Cmax) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  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 [ Time Frame: 13 weeks ]
  8. Time of maximum concentration (Tmax) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  9. Terminal elimination half-life (T1/2) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  10. Total systemic clearance (CLtot) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  11. Volume of distribution during the elimination phase (Vz) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  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 during Treatment Period 1 [ Time Frame: 13 weeks ]
    Special interest is defined as anaphylaxis, thromboembolic events, and bleeding events.

  13. The percentage of subjects with C1-INH HAE with adverse events, serious adverse events, adverse events of special interest, injection site reactions, inhibitory antibodies to CSL312 during Treatment Period 1 [ Time Frame: 13 weeks ]
    Special interest is defined as anaphylaxis, thromboembolic events, and bleeding events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712228


Contacts
Layout table for location contacts
Contact: Trial Registration Coordinator 610.878.4000 clinicaltrials@cslbehring.com

Locations
Layout table for location information
United States, Alabama
Clinical Research Center of Alabama Not yet recruiting
Birmingham, Alabama, United States, 35209
Contact: Call Center         
United States, California
Donald S. Levy Recruiting
Orange, California, United States, 92868
Contact: Call Center         
Allergy & Asthma Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Call Center         
United States, Colorado
Immunoe Health Centers Not yet recruiting
Centennial, Colorado, United States, 80112
Contact: Call Center         
United States, Maryland
Institute for Asthma and Allergy Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Call Center         
United States, Missouri
Washington University, St. Louis Not yet recruiting
Saint Louis, Missouri, United States, 63141
Contact: Call Center         
United States, Ohio
Toledo Institute of Clinical Research Not yet recruiting
Toledo, Ohio, United States, 43617
Contact: Call Center         
United States, Pennsylvania
Pennsylvania State University Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Call Center         
United States, Texas
AARA Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Call Center         
Australia, New South Wales
Campbelltown Hospital Recruiting
Campbelltown, New South Wales, Australia, 2560
Contact: Call Center         
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Call Center         
Canada, Ontario
Allergy and Clinical Immunology McMaster University Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Call Center         
Ottawa Allergy Research Corp Recruiting
Ottawa, Ontario, Canada, K1G 6C6
Contact: Call Center         
Gordon Sussman Clinical Research Inc. Not yet recruiting
Toronto, Ontario, Canada, M4V1R2
Contact: Call Center         
Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Call Center         
Universitätsklinikum Frankfurt Goethe-Universität Not yet recruiting
Frankfurt, Germany, 60590
Contact: Call Center         
Hautklinik und Poliklinik der Universitätsklinik Mainz Recruiting
Mainz, Germany, 55131
Contact: Call Center         
HZRM Hämophilie Zentrum Rhein Main GmbH Recruiting
Mörfelden-Walldorf, Germany, 64546
Contact: Call Center         
Sponsors and Collaborators
CSL Behring
Investigators
Layout table for investigator information
Study Director: Study Director CSL Behring LLC

Layout table for additonal information
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03712228     History of Changes
Other Study ID Numbers: CSL312_2001
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents