A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
NCT ID: NCT03712228
Last Updated: 2022-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2018-10-29
2021-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Subjects with C1-INH HAE receiving buffer only
Placebo
Buffer without active ingredient
CSL312 (low)
Subjects with C1-INH HAE receiving low dose CSL312
Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
CSL312 (med)
Subjects with C1-INH HAE receiving medium dose CSL312
Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
CSL312 (high)
Subjects with C1-INH HAE receiving high dose CSL312
Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
CSL312 (med/high)
Subjects with C1-INH HAE receiving medium/high dose CSL312
Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Interventions
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Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Placebo
Buffer without active ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring LLC
Locations
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Donald S. Levy
Orange, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Immunoe Health Centers
Centennial, Colorado, United States
Institute for Asthma and Allergy
Chevy Chase, Maryland, United States
The Mount Sinai Hospital
New York, New York, United States
Pennsylvania State University
Hershey, Pennsylvania, United States
AARA Research Center
Dallas, Texas, United States
Campbelltown Hospital
Campbelltown, New South Wales, Australia
University of Alberta
Edmonton, Alberta, Canada
Allergy and Clinical Immunology McMaster University
Hamilton, Ontario, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada
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, , Germany
Barzilai University Medical Center
Ashkelon, , Israel
Countries
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References
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Craig TJ, Levy DS, Reshef A, Lumry WR, Martinez-Saguer I, Jacobs JS, Yang WH, Ritchie B, Aygoren-Pursun E, Keith PK, Busse P, Feuersenger H, Alexandru Bica M, Jacobs I, Pragst I, Magerl M. Garadacimab for hereditary angioedema attack prevention: long-term efficacy, quality of life, and safety data from a phase 2, randomised, open-label extension study. Lancet Haematol. 2024 Jun;11(6):e436-e447. doi: 10.1016/S2352-3026(24)00081-4. Epub 2024 May 3.
Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
Craig T, Magerl M, Levy DS, Reshef A, Lumry WR, Martinez-Saguer I, Jacobs JS, Yang WH, Ritchie B, Aygoren-Pursun E, Keith PK, Busse P, Feuersenger H, Pawaskar D, Jacobs I, Pragst I, Doyle MK. Prophylactic use of an anti-activated factor XII monoclonal antibody, garadacimab, for patients with C1-esterase inhibitor-deficient hereditary angioedema: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2022 Mar 5;399(10328):945-955. doi: 10.1016/S0140-6736(21)02225-X. Epub 2022 Feb 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-000605-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL312_2001
Identifier Type: -
Identifier Source: org_study_id
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