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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02135692
Ethics application status
Date submitted
8/05/2014
Date registered
12/05/2014

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
Treatment: Other - 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.


Treatment: Other: 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
Treatment: Other
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
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)
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
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
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Number of Participants Withdrawn From the Study Due to Lack of Efficacy and Adverse Events
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
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
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)
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
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
Timepoint [8] 0 0
Baseline (Week 0) to Week 168
Secondary outcome [9] 0 0
Change From Baseline in Pulse Rate
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)
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
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
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
Sex
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
NA
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
29/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2017
Sample size
Target
Accrual to date
Final
339
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
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
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
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Chile
State/province [24] 0 0
Reg Del Libert Bern Ohiggins
Country [25] 0 0
Chile
State/province [25] 0 0
Santiago
Country [26] 0 0
Chile
State/province [26] 0 0
Talcahuano
Country [27] 0 0
Czechia
State/province [27] 0 0
Brno
Country [28] 0 0
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
State/province [32] 0 0
Kremlin-Bicêtre
Country [33] 0 0
France
State/province [33] 0 0
Lille cedex
Country [34] 0 0
France
State/province [34] 0 0
Lyon cedex 04
Country [35] 0 0
France
State/province [35] 0 0
Marseille cedex 20
Country [36] 0 0
France
State/province [36] 0 0
Montpellier cedex 5
Country [37] 0 0
France
State/province [37] 0 0
Nantes cedex 1
Country [38] 0 0
France
State/province [38] 0 0
Paris Cedex 18
Country [39] 0 0
France
State/province [39] 0 0
Perpignan
Country [40] 0 0
France
State/province [40] 0 0
Strasbourg
Country [41] 0 0
Germany
State/province [41] 0 0
Bayern
Country [42] 0 0
Germany
State/province [42] 0 0
Brandenburg
Country [43] 0 0
Germany
State/province [43] 0 0
Hessen
Country [44] 0 0
Germany
State/province [44] 0 0
Niedersachsen
Country [45] 0 0
Germany
State/province [45] 0 0
Rheinland-Pfalz
Country [46] 0 0
Germany
State/province [46] 0 0
Schleswig-Holstein
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Hamburg
Country [49] 0 0
Germany
State/province [49] 0 0
Magdeburg
Country [50] 0 0
Italy
State/province [50] 0 0
Campania
Country [51] 0 0
Italy
State/province [51] 0 0
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
State/province [55] 0 0
Veneto
Country [56] 0 0
Japan
State/province [56] 0 0
Chiba
Country [57] 0 0
Japan
State/province [57] 0 0
Fukuoka
Country [58] 0 0
Japan
State/province [58] 0 0
Gunma
Country [59] 0 0
Japan
State/province [59] 0 0
Hokkaido
Country [60] 0 0
Japan
State/province [60] 0 0
Ibaraki
Country [61] 0 0
Japan
State/province [61] 0 0
Kanagawa
Country [62] 0 0
Japan
State/province [62] 0 0
Okinawa
Country [63] 0 0
Japan
State/province [63] 0 0
Osaka
Country [64] 0 0
Japan
State/province [64] 0 0
Tokyo
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Anyang-Si Gyeonggi-do
Country [66] 0 0
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
State/province [71] 0 0
Amsterdam
Country [72] 0 0
Netherlands
State/province [72] 0 0
Leeuwarden
Country [73] 0 0
Poland
State/province [73] 0 0
Bialystok
Country [74] 0 0
Poland
State/province [74] 0 0
Krakow
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Chelyabinsk
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Moscow
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Saint-Petersburg
Country [78] 0 0
Russian Federation
State/province [78] 0 0
St. Petersburg
Country [79] 0 0
Spain
State/province [79] 0 0
Alicante
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
Country [81] 0 0
Spain
State/province [81] 0 0
Pozuelo De Alarcón/Madrid
Country [82] 0 0
Ukraine
State/province [82] 0 0
Kharkiv
Country [83] 0 0
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/Posting.aspx?ID=20059


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02135692