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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01691521




Registration number
NCT01691521
Ethics application status
Date submitted
20/09/2012
Date registered
24/09/2012

Titles & IDs
Public title
Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
Scientific title
MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
Secondary ID [1] 0 0
115588
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
Description of intervention(s) / exposure
Treatment: Drugs - Mepolizumab IV
Treatment: Drugs - Mepolizumab SC
Treatment: Drugs - IV Placebo
Treatment: Drugs - SC Placebo

Experimental: Mepolizumab IV - Mepolizumab 75 mg will be administered intravenously approximately every 4 weeks with the last dose at week 32. Subjects in the Mepolizumab IV arm will receive mepolizumab 75 mg intravenously and placebo SC once every 4 weeks with the last dose at Week 28 (total of 8 doses)

Experimental: Mepolizumab SC - Subjects in the Mepolizumab SC arm will receive mepolizumab 100 mg SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)

Placebo comparator: Placebo - Subjects in the Placebo arm will receive matching placebo SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)


Treatment: Drugs: Mepolizumab IV
Mepolizumab 75 mg IV will be administered every 4 weeks with the last dose at Week 28

Treatment: Drugs: Mepolizumab SC
Mepolizumab 100 mg SC will be administered every 4 weeks with the last dose at Week 28

Treatment: Drugs: IV Placebo
Normal saline (placebo) will be administered IV every 4 weeks with the last dose at Week 28

Treatment: Drugs: SC Placebo
Normal saline (placebo) will be administered SC every 4 weeks with the last dose at Week 28
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Clinically Significant Exacerbations of Asthma Per Year
Timepoint [1] 0 0
From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose
Secondary outcome [1] 0 0
Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year
Timepoint [1] 0 0
From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose
Secondary outcome [2] 0 0
Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year
Timepoint [2] 0 0
From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose
Secondary outcome [3] 0 0
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32
Timepoint [3] 0 0
Baseline, Week 32
Secondary outcome [4] 0 0
Mean Change From Baseline in the St. George's Respiratory Questionnaire Total Score at Week 32
Timepoint [4] 0 0
Baseline, Week 32

Eligibility
Key inclusion criteria
* 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
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
8/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2014
Sample size
Target
Accrual to date
Final
580
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 hospital [5] 0 0
GSK Investigational Site - Parkville
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 postcode(s) [5] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Minnesota
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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United States of America
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Utah
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Argentina
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Santa Fe
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Argentina
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Ciudad Autónoma de Buenos Aires
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liège
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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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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France
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Le Kremlin-Bicêtre Cedex
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France
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Lille cedex
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France
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Lyon cedex 04
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France
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Marseille cedex 20
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France
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Montpellier cedex 5
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France
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Perpignan
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France
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Saint Pierre cedex
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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
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Germany
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Rheinland-Pfalz
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Germany
State/province [42] 0 0
Sachsen-Anhalt
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Germany
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Berlin
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Germany
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Hamburg
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Liguria
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Italy
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Puglia
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Italy
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Toscana
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Italy
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Umbria
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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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Gunma
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Hiroshima
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Hokkaido
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Hyogo
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Ibaraki
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Mie
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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
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Korea, Republic of
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Bucheon-si,
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Korea, Republic of
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Cheongju, Chungcheongbuk-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Donggu Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeonju-si, Jeollabuk-Do
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Korea, Republic of
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Kangwon-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon, Kyonggi-do
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Mexico
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Jalisco
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Mexico
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Nuevo León
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Mexico
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México DF
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Pozuelo De Alarcón/Madrid
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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Mykolayiv
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Ukraine
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Vinnytsia
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United Kingdom
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Bradford
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
State/province [92] 0 0
Plymouth
Country [93] 0 0
United Kingdom
State/province [93] 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?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01691521