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CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04656418
Recruitment Status : Completed
First Posted : December 7, 2020
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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Brief Summary:
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Biological: CSL312 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
Actual Study Start Date : January 13, 2021
Actual Primary Completion Date : June 7, 2022
Actual Study Completion Date : June 7, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CSL312
Subjects with C1-INH HAE receiving CSL312
 Biological: CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
Other Names:
  • Factor XIIa antagonist monoclonal antibody
  • garadacimab
Placebo Comparator: Placebo
Subjects with C1-INH HAE receiving buffer only
 Drug: Placebo
Buffer without active ingredient


Outcome Measures
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Primary Outcome Measures :
  1. Time-normalized number of hereditary angioedema (HAE) attacks during treatment period [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Change in the HAE attack rate during the treatment period compared to the run-in period [ Time Frame: up to 6 months ]
  2. Time-normalized number of attacks requiring on-demand treatment [ Time Frame: 6 months, and first 3 months and second 3 months ]
  3. Time-normalized number of moderate and/or severe HAE attacks [ Time Frame: 6 months, and first 3 months and second 3 months ]
  4. Time-normalized number of HAE attacks at various timepoints during the treatment period [ Time Frame: First 3 months and second 3 months and 6 months ]
  5. Percent change in the time-normalized number of HAE attacks between CSL312 and Placebo [ Time Frame: 6 months, and first 3 months and second 3 months ]
  6. Subject's Global Assessment of Response to Therapy (SGART) [ Time Frame: Up to 6 months ]
    Comparison of the distribution of responses to therapy between CSL312 and placebo based on proportions of subjects with"excellent," "good," "fair," "poor or none" response to therapy

  7. Number of subjects with adverse events, adverse events of special interest, serious adverse events, CSL312-induced anti-CSL312 antibodies, clinically significant abnormalities in laboratory assessments [ Time Frame: Up to 8 months ]
  8. Percent of subjects with Adverse events, adverse events of special interest, serious adverse events, CSL312-induced anti-CSL312 antibodies, clinically significant abnormalities in laboratory assessments [ Time Frame: Up to 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening

Exclusion Criteria:

  • Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3
Contacts and Locations
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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): NCT04656418


Locations
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Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04656418    
Other Study ID Numbers: CSL312_3001
2020-000570-25 ( EudraCT Number )
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
Access Criteria:

Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.

An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.

The requesting party must execute an appropriate data sharing agreement before IPD will be made available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hereditary Complement Deficiency Diseases
Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes