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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02135692




Registration number
NCT02135692
Ethics application status
Date submitted
8/05/2014
Date registered
12/05/2014
Date last updated
3/12/2019

Titles & IDs
Public title
A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects
Scientific title
A Multi-Centre, Open-Label, Study of Mepolizumab in a Subset of Subjects With a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial
Secondary ID [1] 0 0
2014-000314-54
Secondary ID [2] 0 0
201312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Other interventions - Mepolizumab
Treatment: Drugs - SOC

Experimental: Mepolizumab 100 mg - All subjects will receive mepolizumab 100mg administered SC into the upper arm or thigh approximately every 4 weeks.


Other interventions: Mepolizumab
Mepolizumab is a fully humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks. Mepolizumab will be supplied as a lyophilised cake in sterile vials for individual use.

Treatment: Drugs: SOC
Standard of Care (SOC) will differ by participant, however it will generally include oral corticosteroids and an inhaled controller medicine (an inhaled corticosteroid plus a long acting beta agonist) and/or short acting beta agonists

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Rate of On-treatment Exacerbations Per Year - Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids intravenous (IV) or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. On-Treatment data between first dose date and earliest of Withdrawal date/last dose + 28 days was considered for analysis. Analysis of the number of exacerbations was performed using a negative binomial generalized linear model.
Timepoint [1] 0 0
Baseline (Week 0) to Week 172
Primary outcome [2] 0 0
Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE) - An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose+28 days.
Timepoint [2] 0 0
Baseline (Week 0) to Week 172
Secondary outcome [1] 0 0
Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score - The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.
Timepoint [1] 0 0
Baseline (Week 0) to Week 168
Secondary outcome [2] 0 0
Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1 - FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline and Weeks 24, 48, 72, 96, 120, 144 and 168. Spirometry was performed within 1 hour of the Baseline assessment. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Data between first dose date and earliest of Withdrawal date/last dose + 28 days considered on-treatment.
Timepoint [2] 0 0
Baseline (Week 0) to Week 168
Secondary outcome [3] 0 0
Number of Participants Withdrawn From the Study Due to Lack of Efficacy and Adverse Events - AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Number of participants withdrawn due to lack of efficacy and adverse events from the study have been presented.
Timepoint [3] 0 0
Baseline (Week 0) to Week 172
Secondary outcome [4] 0 0
Number of Participants Hospitalized Due to Adverse Events Including Asthma Exacerbations - AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of mepolizumab date and before/on last dose of mepolizumab + 28 days.
Timepoint [4] 0 0
Baseline (Week 0) to Week 172
Secondary outcome [5] 0 0
Number of Participants With AEs Including Both Systemic (Allergic and Non-allergic) and Local Site Reactions - AEs were collected from the Baseline visit until the follow-up visit (Week 172). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. Number of participants with AEs including both systemic (i.e. allergic/immunoglobulin (Ig)E-mediated and non-allergic) and local site reactions have been presented.
Timepoint [5] 0 0
Baseline (Week 0) to Week 172
Secondary outcome [6] 0 0
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) - Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)..
Timepoint [6] 0 0
Baseline (Week 0) to Week 172
Secondary outcome [7] 0 0
Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline - Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Participants with maximum change from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.
Timepoint [7] 0 0
Baseline (Week 0) to Week 172
Secondary outcome [8] 0 0
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure - Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.
Timepoint [8] 0 0
Baseline (Week 0) to Week 168
Secondary outcome [9] 0 0
Change From Baseline in Pulse Rate - Vital sign measurements including pulse rate was done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.
Timepoint [9] 0 0
Baseline (Week 0) to Week 168
Secondary outcome [10] 0 0
Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb) - Blood samples were collected for the determination of ADA just prior to administration of mepolizumab. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. The highest value post-Baseline visit are based on each participant's highest post-Baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-Baseline would be positive for a participant who had both negative and positive post-Baseline results. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Timepoint [10] 0 0
Baseline (Week 0) to Week 172
Secondary outcome [11] 0 0
Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline - Blood samples were collected to assess clinical chemistry laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the "To Normal or No Change" category. Alanine Aminotransferase=ALT. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Timepoint [11] 0 0
Baseline (Week 0) to Week 172
Secondary outcome [12] 0 0
Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline - Blood samples were collected to assess hematology laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the "To Normal or No Change" category.
Timepoint [12] 0 0
Baseline (Week 0) to Week 172

Eligibility
Key inclusion criteria
- Informed Consent: Prior to commencing any study related activities, subjects must be
able and willing to provide written informed consent.

- Male or Eligible Female Subjects: To be eligible for the study, females of
child-bearing potential must commit to consistent and correct use of an acceptable
method of birth control and for 4 months after the last study drug administration. A
urine pregnancy test is required of all females of childbearing potential at the
initial Baseline Visit (Visit 1).

- French Subjects Only: In France, a subject will be eligible for inclusion in this
study only if either affiliated to or a beneficiary of a social security category.

- MEA115661 Participation: Subjects must have completed Visit 14 of MEA115661.

- Current Anti-Asthma Therapy: The subject's asthma has been treated with an ICS
controller medication for the last 8 months with fluticasone propionate (FP) >=500
mcg/day (or equivalent).

- Disease Severity: Subjects must be assessed as having life-threatening /serious
debilitating asthma in order to enroll, as defined by the following: Subjects enrolled
in MEA115588 must meet one of the following criteria: a) Subject has a history of at
least one intubation during their lifetime; b) >=3 asthma exacerbations in the 12
months prior to screening for MEA115588; c) >=1 or more hospitalization for asthma
exacerbation in the 12 months prior to screening for MEA115588. Subjects enrolled in
MEA115575 must meet one of the following criteria: d) Subject has a history of at
least one intubation during their lifetime; e) Their optimized dose at randomization
in MEA115575 was >=10mg of prednisone; f) >=1 or more hospitalization for asthma
exacerbation in the 12 months prior to screening for MEA115575.

- Clinical Benefit: Subjects must have experienced documented clinical benefit to
enroll. Subjects must meet the following criteria demonstrating clinical benefit:
Subjects enrolled in MEA115588 who received mepolizumab must meet all of the following
criteria: a) Subject must have had a reduction in their exacerbation frequency by
>=50% during MEA115588. The baseline for comparison is the total number of
exacerbations reported in the 12 months prior to screening for MEA115588. b) The
investigator response on the "Clinician-Rated Response to Therapy" questionnaire at
Visit 10 was either: mildly improved, moderately improved or significantly improved.
Subjects enrolled in MEA115588 who received placebo must meet all of the following
criteria: c) Subject must have had a reduction in their exacerbation frequency by
>=50% during the first 8 months of MEA115661. The baseline for comparison is the total
number of exacerbations reported in the 12 months prior to screening for MEA115588; d)
The investigator confirms that the subject demonstrated improvement during MEA115661.
Subjects enrolled in MEA115575 who received mepolizumab must meet all of the following
criteria: e) Subject must have reduced their oral corticosteroid dose by >=50% during
MEA115575. The baseline for comparison is the subject's optimized oral corticosteroid
(OCS) dose at randomization in MEA115575; f) The investigator response on the
"Clinician-Rated Response to Therapy" questionnaire at Visit 9 was either: mildly
improved, moderately improved or significantly improved. Subjects enrolled in
MEA115575 who received placebo must meet all of the following criteria: g) Subject
must have reduced their oral corticosteroid dose at randomization by >=50% in the
first 6 months of MEA115661. The baseline for comparison is the subject's optimized
OCS dose at randomization in MEA115575; h) The investigator confirms that the subject
demonstrated improvement during MEA115661.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Health Status: Clinically significant change in health status during MEA115661 which
in the opinion of the investigator would make the subject unsuitable for participation
in this long-term study.

- Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled
if they plan to become pregnanDeart during the time of study participation.

- Exacerbation History: Subjects who received placebo in MEA115588 and had NO
exacerbations during the study.

- Oral Corticosteroid Use: Subjects who received placebo in MEA115575 and were able to
discontinue oral corticosteroid therapy by the end of the study.

- Smoking Status: Current smokers

- Previous Significant Protocol Deviation: Subjects who were excluded from the per
protocol analysis due to significant protocol deviations in either study MEA115575 or
MEA115588.

- Electrocardiogram (ECG) Assessment: A clinically significant ECG abnormality at the
exit visit of MEA115661, as determined by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - New Lambton
Recruitment hospital [2] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [3] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [4] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
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New York
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United States of America
State/province [8] 0 0
North Carolina
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United States of America
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Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Mendoza
Country [14] 0 0
Argentina
State/province [14] 0 0
Santa Fe
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liège
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Manitoba
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
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Canada
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Quebec
Country [24] 0 0
Chile
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Reg Del Libert Bern Ohiggins
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Chile
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Santiago
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Chile
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Talcahuano
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Czechia
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Brno
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Czechia
State/province [28] 0 0
Olomouc
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 4
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha 8
Country [31] 0 0
France
State/province [31] 0 0
Gières
Country [32] 0 0
France
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Kremlin-Bicêtre
Country [33] 0 0
France
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Lille cedex
Country [34] 0 0
France
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Lyon cedex 04
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France
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Marseille cedex 20
Country [36] 0 0
France
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Montpellier cedex 5
Country [37] 0 0
France
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Nantes cedex 1
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France
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Paris Cedex 18
Country [39] 0 0
France
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Perpignan
Country [40] 0 0
France
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Strasbourg
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Hessen
Country [44] 0 0
Germany
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Niedersachsen
Country [45] 0 0
Germany
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Rheinland-Pfalz
Country [46] 0 0
Germany
State/province [46] 0 0
Schleswig-Holstein
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Germany
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Berlin
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Germany
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Hamburg
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Germany
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Magdeburg
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Italy
State/province [50] 0 0
Campania
Country [51] 0 0
Italy
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Emilia-Romagna
Country [52] 0 0
Italy
State/province [52] 0 0
Liguria
Country [53] 0 0
Italy
State/province [53] 0 0
Puglia
Country [54] 0 0
Italy
State/province [54] 0 0
Umbria
Country [55] 0 0
Italy
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Veneto
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
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Hokkaido
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Japan
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Ibaraki
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Japan
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Kanagawa
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Japan
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Okinawa
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Anyang-Si Gyeonggi-do
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Korea, Republic of
State/province [66] 0 0
Bucheon city, Gyenggi-do
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Cheongju, Chungcheongbuk-do
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Donggu Gwangju
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Seoul
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Suwon-si, Gyeonggi-do
Country [71] 0 0
Netherlands
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Amsterdam
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Netherlands
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Leeuwarden
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Poland
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Bialystok
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Poland
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Krakow
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Russian Federation
State/province [75] 0 0
Chelyabinsk
Country [76] 0 0
Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
Country [78] 0 0
Russian Federation
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St. Petersburg
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Spain
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Alicante
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Spain
State/province [80] 0 0
Barcelona
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Spain
State/province [81] 0 0
Pozuelo De Alarcón/Madrid
Country [82] 0 0
Ukraine
State/province [82] 0 0
Kharkiv
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Ukraine
State/province [83] 0 0
Kiev
Country [84] 0 0
Ukraine
State/province [84] 0 0
Mykolaiv
Country [85] 0 0
Ukraine
State/province [85] 0 0
Vinnytsia
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Leicestershire
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Bradford
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Plymouth
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-center, open-label, long-term study of subcutaneously (SC) administered
mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic
asthma. This study will enroll a subset of subjects from Study MEA115661 who have
demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy
are individuals at greatest risk of serious deterioration of their health status. In order to
target individuals at greatest risk for serious deterioration of their health status, only
subjects from the MEA115661 study with a history of life-threatening or seriously
debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility
criteria for the study will be offered the opportunity to consent for this study of up to 128
weeks in length (including the Follow-Up Visit). This study will give opportunity to extend
the collection of clinical data for long-term use and further assess the sustainability of
efficacy in a population likely to experience significant loss of asthma control and the need
for higher doses of systemic steroids if returned to SOC only.
Trial website
https://clinicaltrials.gov/show/NCT02135692
Trial related presentations / publications
Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications