Clinical Trial Results:
A Multi-Center, Randomized, Double-Blind, Placebo-
Controlled study to investigate the efficacy and safety of 52 weeks treatment with QGE031 subcutaneous (s.c). in Asthma Patients not adequately controlled by medium- or high-dose inhaled corticosteroid (ICS) plus long acting β2-agonist (LABA) with or without oral corticosteroid (OCS)
Summary
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EudraCT number |
2014-003155-57 |
Trial protocol |
GB HU IT DE BE ES SK NL LU |
Global end of trial date |
07 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Mar 2017
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First version publication date |
09 Mar 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CQGE031B2204
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02336425 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
CH-4002, Basel, Switzerland,
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Public contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
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Scientific contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Mar 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Mar 2016
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of the study was to evaluate the efficacy of QGE031 (24 mg, 72 mg,
240 mg s.c. q4w) compared to placebo on top of standard of care (SoC) in atopic patients with asthma who were
not adequately controlled by medium- or high-dose ICS plus LABA with or without OCS on
the reduction in rate of severe asthma exacerbations during 52 weeks of treatment.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
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Background therapy |
A short-acting β2-agonist (SABA) (salbutamol/albuterol) was provided to patients for use as a rescue medication. For the treatment of potential anaphylactic reactions, patients were supplied epinephrine autoinjector. If an epinephrine auto-injector was not available locally, the administration of epinephrine followed local standard of care. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Sep 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Hungary: 3
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Country: Number of subjects enrolled |
Netherlands: 1
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Country: Number of subjects enrolled |
Canada: 1
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Country: Number of subjects enrolled |
Japan: 2
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Country: Number of subjects enrolled |
Italy: 1
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Country: Number of subjects enrolled |
Slovakia: 2
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Worldwide total number of subjects |
10
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EEA total number of subjects |
7
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
9
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||
Pre-assignment
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Screening details |
Participants were randomized to one of the four treatment arms. | |||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Data analyst, Assessor | |||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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QGE031 240 mg | |||||||||||||||||||||||||
Arm description |
QGE031 240 mg subcutaneous injection every 4 weeks | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
QGE031
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Investigational medicinal product code |
QGE031
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
QGE031 240 mg subcutaneous injection every 4 weeks
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Arm title
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QGE031 72 mg | |||||||||||||||||||||||||
Arm description |
QGE031 72 mg subcutaneous injection every 4 weeks | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
QGE031
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Investigational medicinal product code |
QGE031
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
QGE031 72 mg subcutaneous injection every 4 weeks
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Arm title
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QGE031 24 mg | |||||||||||||||||||||||||
Arm description |
QGE031 24 mg subcutaneous injection every 4 weeks | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
QGE031
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Investigational medicinal product code |
QGE031
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
QGE031 24 mg subcutaneous injection every 4 weeks
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Arm title
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Placebo to QGE031 | |||||||||||||||||||||||||
Arm description |
Placebo subcutaneous injection every 4 weeks | |||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Matching placebo to QGE031 subcutaneous injection every 4 weeks
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Baseline characteristics reporting groups
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Reporting group title |
QGE031 240 mg
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Reporting group description |
QGE031 240 mg subcutaneous injection every 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
QGE031 72 mg
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Reporting group description |
QGE031 72 mg subcutaneous injection every 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
QGE031 24 mg
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Reporting group description |
QGE031 24 mg subcutaneous injection every 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo to QGE031
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Reporting group description |
Placebo subcutaneous injection every 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
QGE031 240 mg
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Reporting group description |
QGE031 240 mg subcutaneous injection every 4 weeks | ||
Reporting group title |
QGE031 72 mg
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Reporting group description |
QGE031 72 mg subcutaneous injection every 4 weeks | ||
Reporting group title |
QGE031 24 mg
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Reporting group description |
QGE031 24 mg subcutaneous injection every 4 weeks | ||
Reporting group title |
Placebo to QGE031
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Reporting group description |
Placebo subcutaneous injection every 4 weeks |
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End point title |
QGE031 compared to placebo in atopic asthma patients on the reduction in rate of severe asthma exacerbations [1] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 52
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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Notes [2] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [3] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [4] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [5] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
QGE031 compared to placebo in all asthma patients on the reduction in rate of severe asthma exacerbations | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Week 52
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Notes [6] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [7] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [8] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [9] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
QGE031 compared to placebo in non-atopic asthma patients on the reduction in rate of severe asthma exacerbations | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Week 52
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Notes [10] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [11] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [12] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [13] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on the reduction in rate of asthma exacerbations (by severity) | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Week 52
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Notes [14] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [15] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [16] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [17] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on time to first asthma exacerbations (by severity) | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Week 52
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Notes [18] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [19] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [20] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [21] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on change from baseline in Asthma Control Questionnaire (ACQ) | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
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Notes [22] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [23] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [24] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [25] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on change from baseline in Asthma Control Diary (ACD) | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Over 52 weeks (Treatment) and 20 weeks (follow-up)
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Notes [26] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [27] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [28] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [29] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on Forced Expiratory Volume in 1 second (FEV1) | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
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Notes [30] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [31] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [32] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [33] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on Peak expiratory flow (PEF) in the morning and evening | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Over 52 weeks (Treatment) and 20 weeks (follow-up)
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Notes [34] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [35] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [36] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [37] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on Total daily symptom score | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Over 52 weeks (Treatment) and 20 weeks (follow-up)
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|||||||||||||||||||||
Notes [38] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [39] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [40] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [41] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
Response to QGE031 between atopic asthma and non-atopic asthma | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Over 52 weeks (treatment) and 20 weeks (follow up)
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Notes [42] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [43] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [44] - Due to the small number of patients randomized, the planned statistical analysis was not performed. [45] - Due to the small number of patients randomized, the planned statistical analysis was not performed. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
QGE031 240 mg
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Reporting group description |
QGE031 240 mg subcutaneous injection every 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
QGE031 72 mg
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Reporting group description |
QGE031 72 mg subcutaneous injection every 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
QGE031 24 mg
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Reporting group description |
QGE031 24 mg subcutaneous injection every 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo to QGE031
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Reporting group description |
Placebo subcutaneous injection every 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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25 Feb 2015 |
This amendment 1 was triggered by a request from the European Health Authorities as part of the VHP (Voluntary Harmonization Procedure) process. Specifically, VHP requested the clarifications for the composition and the independency of the review committees from Novartis. Accordingly this amendment provided further clarification of the two committees that were supposed to review the data from the two pre-specified interim analyses. |
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17 Mar 2015 |
This amendment 2 was triggered by a request from the European Health Authorities as part of the VHP (Voluntary Harmonization Procedure) process. VHP requested to change the contraception method in the exclusion criteria based on “Recommendations related to contraception and pregnancy testing in clinical trials” issued by Clinical Trial Facilitation Group on 15-Sep-2014. |
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24 Apr 2015 |
This amendment 3 was triggered by feasibility challenges potentially affecting the conduct of the study. The detailed changes are outlined in the study protocol |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Study was terminated due to the efficacy results from the Phase II study CQGE031B2201 (NCT01716754). Data analyses were not performed due to the very limited dataset (only 10 participants received study medication of the 440 participants planned). |