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Trial record 1 of 1 for:    csl312_2001
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A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)

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ClinicalTrials.gov Identifier: NCT03712228
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 28, 2018
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

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 : January 2020
Estimated Study Completion Date : November 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 person-time adjusted rate of HAE attack-free subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Maximum concentration (Cmax) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  8. 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 ]
  9. Accumulation ratio (AR) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  10. Time of maximum concentration (Tmax) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  11. Terminal elimination half-life (T1/2) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  12. Total systemic clearance (CLtot) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  13. Volume of distribution during the elimination phase (Vz) of CSL312 in subjects with C1-INH HAE during Treatment Period 1 [ Time Frame: 13 weeks ]
  14. 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.

  15. 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.



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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
Contact: Trial Registration Coordinator 610.878.4000 clinicaltrials@cslbehring.com

Locations
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 Not yet recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Call Center         
United States, Ohio
Toledo Institute of Clinical Research Not yet recruiting
Toledo, Ohio, United States, 43617
Contact: Call Center         
United States, Texas
AARA Research Center Not yet recruiting
Dallas, Texas, United States, 75231
Contact: Call Center         
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Study Director CSL Behring LLC

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: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant 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
Immunologic Factors
Physiological Effects of Drugs