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Lanadelumab in Bradykinin Angioedema (KALAN)

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Enrolling

Conditions

Angioedema

Study type

Observational

Funder types

Other

Identifiers

NCT04597944
2020-A01528-31 (Other Identifier)
38RC20.187

Details and patient eligibility

About

A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema

Full description

The bradykinin-angioedema (AE-BK) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening.

The clinical symptoms depend on accumulation of bradykinin (BK), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. BK formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (HK).

Lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing BK production; it represents an attractive therapeutic strategy for BK-AE prophylaxis.

The aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved HK and the immunogenicity of the lanadelumab.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male/female >18 years old
  • Patient with hereditary or acquired angioedema
  • Patient treated by lanadelumab
  • Patient whose the biological explorations have been carried out or will be carried out at Laboratory of Immunology of CHUGA
  • Informed consent is obtained from the participant

Exclusion criteria

  • Absence of biological material at T0 and M3 (stored for routine analysis)
  • Person under guardianship or curatorship
  • Female who is pregnant, nursing

Trial design

80 participants in 1 patient group

Participants with Hereditary or Acquired Angioedema
Description:
Participants older than 18 years that are diagnosed with Hereditary or Acquired Angioedema and treated by lanadelumab.

Trial contacts and locations

2

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Central trial contact

Federica Defendi, PhD; Charlotte Kevorkian-Verguet

Data sourced from clinicaltrials.gov

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