Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Able to give written informed consent prior to participation in the study
At least 12 years of age at visit 1 and a minimum weight of 45 kilogram (kg)
A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS)
Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months
Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma
At Visit 1, a pre-bronchodilator FEV1 \<80% (for subjects \>= 18 years of age), a pre-bronchodilator FEV1 \<90% or FEV1:FVC ratio \<0.8 (for subjects 12-17 years of age).
Previously confirmed history of two or more exacerbations requiring treatment with systemic CS
Male or Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
French subjects will be included only if either affiliated to or a beneficiary of a social security category.
You may not be if
Current smokers or former smokers with a smoking history of \>=10 pack years
Presence of a known pre-existing, clinically important lung condition other than asthma
A current malignancy or previous history of malignancy in less than 12 months
Known, pre-existing, unstable liver disease cirrhosis and known biliary abnormalities
Known, pre-existing severe or clinically significant cardiovascular disease
known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment
Subjects with any eosinophilic diseases
QTc(F) ≥450msec or QTc(F) ≥480 msec
A history of alcohol/substance abuse
Subject with known immunodeficiency
Subjects who have received omalizumab within 130 days of Visit 1 or any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1
Subjects who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer
Subjects with allergy/intolerance to a monoclonal antibody or biologic.
Subjects who are pregnant or breastfeeding
Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations
Previously participated in any study with mepolizumab and received investigational product (including placebo)
Clareo Health | Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
