Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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25 April 2016 |
Main ID: |
EUCTR2012-002298-69-DE |
Date of registration:
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17/12/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and safety of QGE031 versus placebo and Omalizumab in patients aged 18-75 years with asthma
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Scientific title:
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A Multi-Center, Randomized, Double Blind, Placebo and Active-Controlled study with exploratory dose-ranging, to investigate the efficacy and safety of 16 weeks treatment with subcutaneous QGE031 in asthma patients not adequately controlled with high-dose inhaled corticosteroids and long acting ß2-agonists |
Date of first enrolment:
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07/05/2013 |
Target sample size:
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457 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002298-69 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 14
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Phase:
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Countries of recruitment
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Argentina
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Canada
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Czech Republic
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Finland
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France
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Germany
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Hungary
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Israel
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Italy
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Mexico
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Poland
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Portugal
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Romania
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Russian Federation
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Singapore
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Slovakia
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Medical Compentence Center (MCC)
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Address:
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Roonstrasse 25
90429
Nürnberg
Germany |
Telephone:
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+491802232300 |
Email:
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infoservice.novartis@novartis.com |
Affiliation:
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Novartis Pharma GmbH, Medizinischer Infoservice |
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Name:
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Medical Compentence Center (MCC)
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Address:
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Roonstrasse 25
90429
Nürnberg
Germany |
Telephone:
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+491802232300 |
Email:
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infoservice.novartis@novartis.com |
Affiliation:
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Novartis Pharma GmbH, Medizinischer Infoservice |
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Key inclusion & exclusion criteria
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Inclusion criteria: -A diagnosis of allergic asthma , uncontrolled on current medication.
-History of at least 1 asthma exacerbation during the last 1 year
-Forced Expiratory Volume in one second (FEV1) of = 40% and = 80% of
the predicted normal value;
- reversibility following administration of bronchodilator must also be
demonstrated (historical positive reversibility or bronchoprovocation
result can be used).
Other inclusion criteria are listed in the clinical study protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 366 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 91
Exclusion criteria: - Baseline IgE levels or body weight outside the omalizumab dosing table
- Use of tobacco products within the previous 6 months.
- Recent asthma attack/exacerbation or asthma worsening/respiratory infection.
Other exclusion criteria are listed in the clinical study protocol
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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asthma MedDRA version: 19.0
Level: PT
Classification code 10003553
Term: Asthma
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Intervention(s)
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Product Code: QGE031 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: QGE031 Current Sponsor code: QGE031 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 120- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
Trade Name: Xolair Product Name: Xolair (Omalizumab) Product Code: IGE025 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: OMALIZUMAB CAS Number: 242138-07-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: 1) Responder rate compared to omalizumab 2) ACQ score 3) Change from baseline in ACQ score less than -1.1 4) AQLQ score
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Timepoint(s) of evaluation of this end point: Baseline, Week 16
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Primary end point(s): Responder rate compared to placebo
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Main Objective: Responder rate compared to placebo
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1) Baseline, Week 16
2) Baseline, Week 4, Week 8, Week 12, Week 16 and Week 28
3) Baseline, Week 16
4) Baseline, Week 16
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Secondary end point(s): 1) Responder rate compared to omalizumab
2) ACQ score
3) Change from baseline in ACQ score less than -1.1
4) AQLQ score
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Secondary ID(s)
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2012-002298-69-FI
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CQGE031B2201
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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