Clinical Trial Results:
An open-label, multi-center, extension study to evaluate the long-term safety of subcutaneous 240 mg QGE031 given every 4 weeks for 52 weeks in allergic asthma patients who completed study CQGE031B2201
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Summary
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EudraCT number |
2013-003683-31 |
Trial protocol |
SK CZ PL FI HU DE IT PT |
Global end of trial date |
22 Mar 2016
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Results information
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Results version number |
v1 |
This version publication date |
30 Mar 2017
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First version publication date |
30 Mar 2017
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Other versions |
v2 |
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 |
CQGE031B2201E1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02075008 | ||
WHO universal trial number (UTN) |
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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 |
22 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 |
22 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 this study was to assess the long-term safety and tolerability of QGE031 (240 mg sc) given every 4 weeks for an additional 12 months in allergic asthma patients who completed the core study CQGE031B2201, as assessed by:
• Incidence and severity of adverse events (AEs) including serious adverse events (SAEs) including any events of special interest
• Changes in vital signs, laboratory assessments, and electrocardiogram (ECGs)
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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 |
All patients were provided with a short-acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication on an ‘as needed basis’ as was previously done in the core study. Patients were advised that between visits they could take their rescue medication for symptoms of intercurrent bronchospasm. In order to standardize measurements, patients were instructed to abstain from taking rescue salbutamol/albuterol within 6 hours of the start of each spirometry visit unless absolutely necessary. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Mar 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Argentina: 37
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Country: Number of subjects enrolled |
Canada: 11
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Country: Number of subjects enrolled |
Czech Republic: 30
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Country: Number of subjects enrolled |
Finland: 2
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Country: Number of subjects enrolled |
France: 1
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Country: Number of subjects enrolled |
Germany: 32
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Country: Number of subjects enrolled |
United Kingdom: 4
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Country: Number of subjects enrolled |
Hungary: 6
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Country: Number of subjects enrolled |
Israel: 14
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Country: Number of subjects enrolled |
Italy: 9
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Country: Number of subjects enrolled |
Korea, Republic of: 15
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Country: Number of subjects enrolled |
Mexico: 3
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Country: Number of subjects enrolled |
Poland: 15
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Country: Number of subjects enrolled |
Portugal: 4
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Country: Number of subjects enrolled |
Romania: 26
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Country: Number of subjects enrolled |
Russian Federation: 18
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Country: Number of subjects enrolled |
Slovakia: 18
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Country: Number of subjects enrolled |
Turkey: 12
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Country: Number of subjects enrolled |
United States: 13
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Worldwide total number of subjects |
270
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EEA total number of subjects |
147
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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) |
237
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From 65 to 84 years |
33
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
This was an open-label, single arm study for participants who completed the core study CQGE031B2201 (NCT01716754). | ||||||||||||||||||||||||||
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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 |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||
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Arms
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Arm title
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QGE031 every 4 weeks (q4w) | ||||||||||||||||||||||||||
Arm description |
QGE031 240 mg subcutaneously q4w | ||||||||||||||||||||||||||
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 subcutaneously q4w
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Baseline characteristics reporting groups
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Reporting group title |
QGE031 every 4 weeks (q4w)
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Reporting group description |
QGE031 240 mg subcutaneously q4w | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
QGE031 every 4 weeks (q4w)
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Reporting group description |
QGE031 240 mg subcutaneously q4w | ||
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End point title |
Numbers of participants with non-serious adverse events (AEs), serious AEs and deaths as a measure of safety and tolerability [1] | ||||||||||||
End point description |
Safety was monitored throughout the study.
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End point type |
Primary
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End point timeframe |
52 weeks
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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: Statistical analysis does not apply to this end point. |
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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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Adverse event reporting additional description |
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator. The one death reported was not related to study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
QGE031 240 mg q4w
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Reporting group description |
QGE031 240 mg q4w | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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22 Apr 2015 |
This amendment included one additional Adjudication Committees (AC) for the assessment of CCV events.
While there was no known mechanism linking IgE suppression to CCV events, statistically non-significant imbalances of these events had been identified in selected omalizumab datasets
and had been reflected in some Xolair country labeling.
In order to closely monitor any potential relationship between IgE suppression and these events, and to strengthen patient safety in this trial and future trials, Novartis had decided to
institute a CCV adjudication committee. The other key change in this amendment was the removal of some exploratory biomarkers from the study protocol. The high number of biomarkers sampled and the required shipping
conditions had frequently been reported as very cumbersome and too complex by the sites. Novartis decided to remove some of the exploratory biomarkers from the protocol. Samples already collected were planned to be analyzed and corresponding results were planned to be included in the final Clinical Study Report (CSR). |
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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. | |||
| The two anaphylaxis events reported as both related to study medication and as serious adverse events reflect two observations on the same patient and on the same day after one injection of study drug. | |||
