Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab

Completed · Phase 4

Conditions studied: Hereditary Angioedema

In brief

This study is designed to evaluate the safety after switching to garadacimab from another prophylactic hereditary angioedema (HAE) treatment (marketed kallikrein \[KK\] inhibitor or plasma-derived C1-esterase inhibitor \[pdC1INH\]prophylactic) when administered once monthly for approximately 3 months in participants aged greater than or equal to (\>=) 12 years with HAE.

Key facts

Study ID

NCT06806657

Run by

CSL Behring

People needed

18

Starts

2025-04-28

Expected to finish

2026-06-29

Last updated by the study team

2026-07-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged >= 12 years at the time of providing written informed consent / assent.
• 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.

You may not qualify if…

• Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria.
• 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.

Where it is running

• 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
• Chronicle Bio — West Valley City, Utah, United States
• McMaster University-Hamilton — Hamilton, Ontario, Canada
• Montreal Clinical Research Institute — Montreal, Quebec, Canada
• Clinique Spécialisée en Allergie de la Capitale — Québec, Canada
• HZRM Hämophilie Zentrum Rhein Main GmbH — Frankfurt, Germany
• Hautklinik und Poliklinik der Universitätsklinik Mainz — Mainz, Germany

Full record on ClinicalTrials.gov

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