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ClinicalTrials.gov ID

NCT04597944

Lead Sponsor

University Hospital, GrenobleOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

80Estimated

Last Update Posted

Mar 19, 2024Actual

Start Date

Sep 18, 2020Actual

Primary Completion Date

Sep 2025Estimated

Completion Date

Sep 2025Estimated

Official Title

Evaluation of the Efficacy of Kallikrein Inhibition by Lanadelumab for Patients With Bradykinin Angioedema: a Cohort Study

Brief Summary

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

Detailed 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.

• Angioedema

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Hospital, GrenobleOTHER

Sebastien.Miranda@chu-rouen.fr+33 (0)2 32 88 90 01