Lanadelumab in Bradykinin Angioedema

Angioedema Clinical Trial

— KALAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04597944
• Other study ID #: 38RC20.187
• Secondary ID: 2020-A01528-31
• Status: Recruiting
• Start date: September 18, 2020
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: University Hospital, Grenoble
• Contact: Federica Defendi, PhD
• Phone: +330476765416
• Email: fdefendi[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble
France	CHU Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema	Levels of cleaved HK measured by Western Blot	3 months
Secondary	Evaluation of the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema between T0 and the others visits	Levels of cleaved HK as measured by Western Blot Ratio Day 7/ Day 0, Ratio Month 6/ Day 0, Ratio Month 12/ Day (and if possible Month 24/ Day 0) of the levels of cleaved HK as measured by Western Blot; - SE2: antidrug antibodies in the sera of patients at Months 3, 6, 12 (and if possible Month 24).	Day 7; 6, 12 and if possible 24 months
Secondary	Immunogenicity of lanadelumab	Levels of antidrug antibodies in the sera of patients	Months 3, 6, 12 (and 24 if possible)
Secondary	Evaluation of therapeutic escape	Increase/absence of decrease of the number of attacks during lanadelumab administration	Months 3, 6, 12 and if possible 24