Mepolizumab Pharmacokinetics Among Patients With Severe Asthma

NCT05495932 | Completed

• 2 other identifiers: RECHMPL22_00352022-A00982-41
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Asthma is a chronic disease characterized by inflammation and obstruction of the airways. Identification of the mechanisms of action of corticosteroids has made it possible to define the type 2 inflammation present in nearly 80% of patients with asthma. Monoclonal antibodies (MAb) in severe asthma target type-2 inflammation. Mepolizumab is a humanized IgG1 (immunoglobulin gamma-1) kappa subclass monoclonal antibody directed specifically against interleukin 5 (IL-5). It acts specifically on eosinophil homeostasis, with IL-5 being a key interleukin in eosinophil maturation. The investigators propose to measure the concentrations of mepolizumab in the serum of asthmatic patients treated with this mAb. The investigators hypothesize that the individual pharmacokinetics (PK) of mepolizumab may differ between clinical responders and non-responders.

Conditions

Asthma

Keywords

Severe asthma; Mepolizumab; Biologics; Response; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Change in Mepolizumab serum concentration

  The primary outcome is the change in trough concentration of mepolizumab in serum at 1-month post-enrolment. Mepolizumab serum concentration will be determine by ELISA

  1 month

Secondary Outcomes (11)

• Mepolizumab serum concentration

  6 months

• Complete blood cell count at 1 month

  1 month

• Complete blood cell count at 6 months

  6 months

• Comparison of lung function by airway obstruction

  6 months

• Comparison of asthma control by ACQ-6 score

  6 months

Study Arms (1)

Eligible patients

EXPERIMENTAL

Diagnostic Test: blood sample

Interventions

blood sample DIAGNOSTIC_TEST

blood sample taken to measure serum mepolizumab concentration at baseline, 1 month and 6 months during study follow-up

Eligible patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age: 18 years old
• History of severe asthma diagnosed by a physician (according to Global Initiative for Asthma (GINA) criteria)
• Treatment with mepolizumab in line with the Marketing Authorization
• Having received at least 6 doses of mepolizumab (monthly subcutaneous administration)
• Documented initial clinical response to mepolizumab

You may not qualify if:

• Other respiratory diseases
• Potential interference from another study
• Immunosuppressive treatment (i.e methotrexate, polyvalent immunoglobulins, other monoclonal antibody for other condition such as cancer; oral and/or inhaled corticosteroids are allowed)
• Populations protected according to the French public health code
• Patient is unavailable, unable or unwilling to attend future visits
• Non-beneficiary of the French national health insurance system
• Lack of informed consent

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

university Hospital of Montpellier

Montpellier, France, 34295, France

Location

University Hospital of Tours

Tours, France, 37044, France

Location

MeSH Terms

Conditions

Asthma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anne-Sophie GAMEZ, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-control study including adult patients with severe asthma successfully treated with mepolizumab for at least 24 weeks, and then divided into two groups at inclusion : responders and non-responders according to the results of blood samples taken at inclusion, 1 month and 6 months during study follow-up The clinical criteria used to define a complete response to mepolizumab are : Reduction of maintenance corticotherapy \> 50% reduction OR dose \>5mg/day; Reduction of exacerbation rate by \> 50%; ACQ-6 score \< 1.5 and no increase in score \> 0.5 since enrolment Patients lacking any one of the previous criteria are classified as non-responders. Clinical response criteria are evaluated at each study visit, and the final classification at 6 months post-inclusion determines study groups to be matched and compared during statistical analyses

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: November 15, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: September 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Datasets that underlie the results reported in the article (text, tables, figures, and appendices) can be requested after the publication process has been completed.
• Access Criteria: The conditions under which members of the public will be granted access to datasets are: * The data will be used/examined in a not-for-profit manner; * The data will not be used in an attempt to identify a participant or group of participants; * The user does not work for a private insurance company; * The data will not be used in support of any kind of private insurance policy or health penalties; * The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights; * The user will state why they wish to access the data. * If the data do not fulfil the requirements of the reference methodology (MR-001) (ex: data about religion, etc.), the appropriate CNIL (National Commission for Computing and Liberties) approval has to be obtained by the user. * If the data will be used outside the European Union, standard contractual clauses have to be signed between Montpellier University Hospital and the user before sharing data.

Locations

FR (2)