209682 - Phase 4 study of mepolizumab 100 mg SC in Indian participants aged =18years with severe eosinophilic asthma requiring maintenance oral corticosteroids
- Conditions
- Health Condition 1: J00-J99- Diseases of the respiratory system
- Registration Number
- CTRI/2020/11/029078
- Lead Sponsor
- GlaxosmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Age1.Participant must be =18 to 65 years of age inclusive, at the time of signing the informed consent.Type of Participant and Disease Characteristics2.Asthma: Evidence of asthma as documented by either: •Airway reversibility (FEV1=12% and 200 ml) demonstrated at Visit 1 (screening), or Visit 2 (Week 0) OR documented in the previous 12 months OR•Airway hyper-responsiveness (methacholine: PC20 of <8mg/mL or histamine: PD20 of <7.8 µmol; mannitol: decrease in FEV1 as per the labelled product instructions) documented in the 12 months prior to Visit 2 (Week 0) OR•Airflow variability in clinic FEV1 =20% between two consecutive clinic visits documented in the 12 months prior to Visit 2 (FEV1 recorded during an exacerbation should not be considered for this criteria) OR•Airflow variability as indicated by >20% diurnal variability in peak flow observed on 3 or more days during the optimisation period3.Participants with Eosinophilic asthma: prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as
FEV1: Persistent airflow obstruction as indicated by:For participants = 18 years of age at Visit 1 (screening), or Visit 2 (Week 0), a pre-bronchodilator FEV1 <80% predicted.For predicted FEV1 values NHANES III values will be used and adjustments to these values will be made for race [Hankinson, 1999]. 4.Eosinophilic Phenotype: Airway inflammation characterized as eosinophilic in nature as indicated by one of the following characteristics:a.An elevated peripheral blood eosinophil level of =300 cells/µL that is related to asthma within the previous 12 months prior to Visit 2 (Week 0)or b.Peripheral baseline eosinophil level =150 cells/µL between Visit 1 (screening) and Visit 2 (Week 0) that is related to asthma5.Patients eligible for mepolizumab treatment as per independent clinical judgment of treating physician in alignment with local prescribing information.
6.Inhaled Corticosteroids: requirement for regular treatment with high dose inhaled corticosteroid in the 6 months prior to Visit 1 (screening).
For 18 years of age and older:•ICS dose must be =880 mcg/day fluticasone propionate (FP) (ex-actuator) or equivalent daily. 7.Controller Medication: Current treatment with an additional controller medication for at least 3 months OR having used and failed an additional controller medication for at least 3 successive months during the prior 12 months [e.g., long-acting beta2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline].
Sex
8.Male or eligible female:Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:a.Is not a woman of childbearing potential (WOCBP)
ORb.Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Appendix 4 during the intervention period and for at least 16 weeks after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.c. A WOCBP must have a negative highly sensitive (Appendix 2) pregnancy test (serum) within 8 weeks before the first dose of study intervention.d. Additional requirements for pregnancy
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1.Concurrent Respiratory Disease: Presence of a clinically important lung condition other than asthma. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
2.Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior screening (Participants who had localized carcinoma (i.e. basal or squamous cell) of the skin which was resected for cure will not be excluded).
3.Liver Disease: Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
4.Cardiovascular: Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to:
•known ejection fraction of <30% OR
•severe heart failure meeting New York Heart Association Class IV (Appendix 5) OR
•hospitalised in the 12 months prior to Visit 1 (screening) for severe heart failure meeting New York Heart Association Class III (Appendix 5) OR
•angina diagnosed less than 3 months prior to Visit 1 (screening) or at Visit 1
5.Other Concurrent Medical Conditions: Participants who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
6.Eosinophilic Diseases: Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophaghitis.
7.Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 (screening) are also to be excluded.
Prior/Concomitant Therapy
8.Omalizumab Use: Participants who have received omalizumab [Xolair] within 130 days of Visit 1 (screening)
9.Other Monoclonal Antibodies: Participants who have received any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1 (screening)
10.Investigational Medications: Participants 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, prior to Visit 1 (this also includes investigational formulations of marketed products).
Prior/Concurrent Clinical Study Experience
11.Participants who have previously participated in any study of mepolizumab and received Investigational Product (including placebo).
Diagnostic assessments
12.ECG: ECG assessment QTcF > 450msec or QTcF > 480 msec for participants with Bundle Branch Block.
Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening (Visit 1) is considered to be clinically significant and would impact the participant’s participation during the study, based on the evaluation of the Investigator.
13.Immunodeficiency: A known immuno
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method