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CompletedNCT06806657Updated Jul 23, 2026

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

A Phase 4 interventional study of Garadacimab in Hereditary Angioedema, sponsored by CSL Behring. Completed at 11 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by CSL Behring · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hereditary Angioedema

Keywords

  • Autosomal dominant disease
  • Hereditary angioedema attack
  • Monoclonal antibody
03

In context

Angioedemas, Hereditary

171 studies on the registry are indexed under Angioedemas, Hereditary; 25 are open to participants now.

This study's enrollment of 18 is below the median of 53 across 115 interventional studies indexed under Angioedemas, Hereditary.

Browse Angioedemas, Hereditary studies →

Lead sponsor

CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Garadacimab

    Biological: Garadacimab

Interventions

  • BiologicalGaradacimab

    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.

    Also known as: CSL312 and Factor XIIa inhibitor monoclonal antibody

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 95 (End of study [EoS])

  2. Percentage of Participants With TEAEs

    Time frame: Up to Day 95 (EoS)

  3. Number of TEAEs

    Time frame: Up to Day 95 (EoS)

  4. Rate of TEAEs per injection

    Time frame: Up to Day 95 (EoS)

  5. Rate of TEAEs per participant year

    Time frame: Up to Day 95 (EoS)

Secondary outcomes

  1. Number of Participants With: Serious Adverse Events (SAEs), Deaths, Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and Adverse Events of Special Interest (AESI)

    The AESIs for garadacimab are severe hypersensitivity including anaphylaxis.

    Time frame: Up to Day 95 (EoS)

  2. Percentage of Participants With: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI

    Time frame: Up to Day 95 (EoS)

  3. Number of SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, AESI and Laboratory Findings Reported as an AE, and AESI

    Time frame: Up to Day 95 (EoS)

  4. Rate per injection of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI

    Time frame: Up to Day 95 (EoS)

  5. Rate per participant year of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI

    Time frame: Up to Day 95 (EoS)

  6. Number of Participants with Anti-garadacimab Antibodies

    Time frame: Up to Day 95 (EoS)

  7. Percentage of Participants with Anti-garadacimab Antibodies

    Time frame: Up to Day 95 (EoS)

  8. Plasma Concentrations of Garadacimab

    Time frame: Up to Day 95 (EoS)

  9. Percentage of Participants who Indicated Their Preference for Garadacimab

    Time frame: Up to Day 95 (EoS)

07

Study locations

11 sites
  • Research Solutions of Arizona
    Litchfield Park, Arizona 85340, United States
  • Allergy and Asthma Clinic of Northwest Arkansas
    Bentonville, Arkansas 72712, United States
  • Donald Levy M.D.
    Orange, California 92868, United States
  • Raffi Tachdjian MD, Inc.
    Santa Monica, California 90404, United States
  • Bernstein Clinical Research Center, LLC
    Cincinnati, Ohio 45236, United States
  • Chronicle Bio
    West Valley City, Utah 84119, United States
  • McMaster University-Hamilton
    Hamilton, Ontario ON L8N3Z5, Canada
  • Montreal Clinical Research Institute
    Montreal, Quebec QC H2W 1R7, Canada
  • Clinique Spécialisée en Allergie de la Capitale
    Québec, G1V 4W2, Canada
  • HZRM Hämophilie Zentrum Rhein Main GmbH
    Frankfurt, 60596, Germany
  • Hautklinik und Poliklinik der Universitätsklinik Mainz
    Mainz, 55131, Germany
08

References and documents

Individual participant data

Plan to share: Yes — CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06806657
Lead sponsor
CSL Behring
Responsible party
Sponsor
First posted
Feb 4, 2025
Start date
Apr 28, 2025
Primary completion
Jun 29, 2026
Completion
Jun 29, 2026
Last update
Jul 23, 2026

Study contacts

Study Director
study director · CSL Behring

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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