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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01691859




Registration number
NCT01691859
Ethics application status
Date submitted
13/09/2012
Date registered
25/09/2012

Titles & IDs
Public title
MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
Scientific title
MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial
Secondary ID [1] 0 0
2012-001643-51
Secondary ID [2] 0 0
115666
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: Drugs - Mepolizumab

Experimental: Mepolizumab - Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.


Treatment: Drugs: Mepolizumab
100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE)
Timepoint [1] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [1] 0 0
Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions
Timepoint [1] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [2] 0 0
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B])
Timepoint [2] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [3] 0 0
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F])
Timepoint [3] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [4] 0 0
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B)
Timepoint [4] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [5] 0 0
Number of Participants With Clinical Chemistry Data of Potential Clinical Concern
Timepoint [5] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [6] 0 0
Number of Participants With Hematology Data of Potential Clinical Concern
Timepoint [6] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [7] 0 0
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure
Timepoint [7] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [8] 0 0
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate
Timepoint [8] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [9] 0 0
Annualized Rate of On-treatment Exacerbations
Timepoint [9] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [10] 0 0
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score
Timepoint [10] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [11] 0 0
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [11] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [12] 0 0
Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb)
Timepoint [12] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [13] 0 0
Number of Participants Who Withdrew Due to Lack of Efficacy
Timepoint [13] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [14] 0 0
Number of Participants Requiring Hospitalizations Due to Adverse Events Including Asthma Exacerbations
Timepoint [14] 0 0
Baseline (Week 0) to Week 240
Secondary outcome [15] 0 0
Number of Participants Who Withdrew Due to AE
Timepoint [15] 0 0
Baseline (Week 0) to Week 240

Eligibility
Key inclusion criteria
* Informed Consent.
* MEA112997 Study Participation: Received at least 2 doses of double-blind investigational product during the MEA112997 trial.
* MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have had a positive risk: benefit ratio.
* Currently being treated with a controller medication and the subject has been on a controller medication for the past 12 weeks.
* Male or Eligible Female Subjects. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control for the duration of the trial and for 4 months after the last study drug administration.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hypersensitivity related to mepolizumab.
* Clinically significant change in health status since completing participation in the MEA112997 trial.
* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
* For those subjects who had a SAE in MEA112997 that was assessed as possibly related to mepolizumab by the investigator.
* Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
* Screening ECG which has a clinically significant abnormality.
* Received Xolair (omalizumab) within the past 130 days.
* Participated in a clinical trial within the past 30 days or have received investigational medication within five terminal half-lives of Screen Visit, whichever is longer.
* Current smokers.

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
28/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2017
Sample size
Target
Accrual to date
Final
347
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 - Adelaide
Recruitment hospital [3] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [4] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [5] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 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
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Ciudad Autónoma de Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Mendoza
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Región Metro De Santiago
Country [18] 0 0
Chile
State/province [18] 0 0
Valparaíso
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago
Country [20] 0 0
Chile
State/province [20] 0 0
Talcahuano
Country [21] 0 0
France
State/province [21] 0 0
Le Kremlin-Bicêtre Cedex
Country [22] 0 0
France
State/province [22] 0 0
Marseille cedex 20
Country [23] 0 0
France
State/province [23] 0 0
Montpellier cedex 5
Country [24] 0 0
France
State/province [24] 0 0
Saint Pierre cedex
Country [25] 0 0
Germany
State/province [25] 0 0
Brandenburg
Country [26] 0 0
Germany
State/province [26] 0 0
Hessen
Country [27] 0 0
Germany
State/province [27] 0 0
Rheinland-Pfalz
Country [28] 0 0
Germany
State/province [28] 0 0
Schleswig-Holstein
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Magdeburg
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Cheongju, Chungcheongbuk-do
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Suwon, Kyonggi-do
Country [33] 0 0
Poland
State/province [33] 0 0
Lodz
Country [34] 0 0
Poland
State/province [34] 0 0
Wroclaw
Country [35] 0 0
Romania
State/province [35] 0 0
Bucharest
Country [36] 0 0
Romania
State/province [36] 0 0
Iasi
Country [37] 0 0
Romania
State/province [37] 0 0
Targu Mures
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Barnaul
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Chelyabinsk
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Kazan
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Moscow
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Saint-Petersburg
Country [43] 0 0
Russian Federation
State/province [43] 0 0
St'Petersburg
Country [44] 0 0
Ukraine
State/province [44] 0 0
Dnipropetrovsk
Country [45] 0 0
Ukraine
State/province [45] 0 0
Donetsk
Country [46] 0 0
Ukraine
State/province [46] 0 0
Kharkiv
Country [47] 0 0
Ukraine
State/province [47] 0 0
Kiev
Country [48] 0 0
Ukraine
State/province [48] 0 0
Kyiv
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Leicestershire
Country [50] 0 0
United Kingdom
State/province [50] 0 0
London
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Manchester
Country [52] 0 0
United Kingdom
State/province [52] 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?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available to whom?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01691859