Lanadelumab in Bradykinin Angioedema

  • STATUS
    Recruiting
  • End date
    Sep 26, 2025
  • participants needed
    80
  • sponsor
    University Hospital, Grenoble
Updated on 26 January 2021
angioedema

Summary

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

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.

Details
Condition Angioneurotic Edema, Urticaria, Vascular Diseases, Hives (Urticaria), angioedema, quincke's edema
Clinical Study IdentifierNCT04597944
SponsorUniversity Hospital, Grenoble
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Urticaria or Hives (Urticaria) or Angioneurotic Edema or Vascular Diseases?
Do you have any of these conditions: Angioneurotic Edema or quincke's edema or Hives (Urticaria) or angioedema or Urticaria or Vascular Diseases?
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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