NCT05495932Completed
Mepolizumab Pharmacokinetics Among Patients With Severe Asthma
Mepolizumab Pharmacokinetics Among Patients With Severe Asthma: Protocol for a Case Control Study Comparing Clinical Responders Versus Non Responders
Source: ClinicalTrials.gov · Last updated 30 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 8 Aug 2022
- Start date
- 15 Nov 2022
- Primary completion date
- 20 Dec 2024
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Asthma
- NCT number
- NCT05495932
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 15 Nov 2022 to the primary completion date, 20 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other respiratory diseases
- Immunosuppressive treatment (i.e methotrexate, polyvalent immunoglobulins, other monoclonal antibody for other condition such as cancer; oral and/or inhaled corticosteroids are allowed)
Other
- Potential interference from another study
- 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
Who the study is looking for
- Minimum age: 18 years old
- History of severe asthma diagnosed by a physician (according to Global Initiative for Asthma (GINA) criteria)
- Subject on a combination of high-dose (ICS equivalent to 1000 μg beclomethasone) and medium dose inhaled corticosteroid and long acting beta-agonists at least 12 months before inclusion
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| University Hospital of Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.