Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab
NCT ID: NCT06806657
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2025-03-19
2026-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Garadacimab
Garadacimab
Participants will receive a loading dose of garadacimab, followed by once monthly garadacimab administration for 2 months. Garadacimab will be given as a subcutaneous injection. The timing for the administration of the loading dose (first administration of garadacimab) is determined by the dosing schedule of the current HAE prophylactic treatment. No washout necessary.
Interventions
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Garadacimab
Participants will receive a loading dose of garadacimab, followed by once monthly garadacimab administration for 2 months. Garadacimab will be given as a subcutaneous injection. The timing for the administration of the loading dose (first administration of garadacimab) is determined by the dosing schedule of the current HAE prophylactic treatment. No washout necessary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a history of response to on-demand HAE treatment for the treatment of acute HAE attacks.
* Documented laboratory diagnosis in medical records of C1-esterase inhibitor hereditary angioedema (HAE-C1INH) type 1 or type 2:
* Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria),
* C1-esterase inhibitor (C1INH) antigen concentration or functional activity less than (\<) 50% of normal as documented in the participant's medical record, or
* C4-antigen concentration below the lower limit of the reference range as documented in the participant's medical record.
For HAE-nC1INH: Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria); an HAE-associated FXII gene mutation (eg, FXII point mutation Thr328Lys or Thr328Arg, or deletion of 72 base pairs \[c.971\_1018 + 24del72\], or duplication of 18 base pairs \[c.892-909dup\]), as documented in the participant's medical record, OR an HAE-associated plasminogen gene mutation (PLG) gene mutation (eg, PLG point mutation Lys330Glu), as documented in the participant's medical record; C1INH antigen concentration or functional activity 70 to 120% of the normal level, as documented in the participant's medical record.
• Use of lanadelumab, berotralstat, or pdC1INH for the prophylactic treatment of HAE and be on a stable (consistent) dose / regimen of such medication for at least 3 months prior to Screening.
Exclusion Criteria
* Use of androgens, antifibrinolytics, or investigational products (other than garadacimab) for routine prophylaxis against HAE attacks.
* Known or suspected hypersensitivity to monoclonal antibody therapy or hypersensitivity to the active substance (garadacimab) or to any of the excipients.
12 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
Locations
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Research Solutions of Arizona
Litchfield Park, Arizona, United States
Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States
Donald Levy M.D.
Orange, California, United States
Raffi Tachdjian MD, Inc.
Santa Monica, California, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Clinique Spécialisée en Allergie de la Capitale
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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Trial Information Contact
Role: primary
Trial Information Contact
Role: primary
Trial Information Contact
Role: primary
Trial Information Contact
Role: primary
Trial Information Contact
Role: primary
Trial Information Contact
Role: primary
Other Identifiers
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2024-517757-27-00
Identifier Type: OTHER
Identifier Source: secondary_id
CSL312_4002
Identifier Type: -
Identifier Source: org_study_id
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