E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate effect on the reduction in rate of severe asthma
exacerbations of different dose levels of QGE031 in asthma patients that
are inadequately controlled with inhaled steroid plus beta-2 agonist
medication with or without oral steroid. Safety will also be assessed.
Comparison will be to placebo. |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the efficacy of QGE031 compared to placebo on top of
SoC in patients (all: atopic and non-atopic) with asthma 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.
2. To evaluate the efficacy of QGE031 compared to placebo on top of
SoC in patients (non-atopic) with asthma 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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A diagnosis of allergic asthma, uncontrolled on current medication.
•History of at least 2 asthma exacerbations 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. |
|
E.4 | Principal exclusion criteria |
History of malignancy of any organ system (other than localized basal cell
carcinoma of the skin or in-situ cervical cancer) within the past 5 years
Patients who have smoked or inhaled tobacco products within 6 month period
prior to Visit 1, or who have a smoking history of greater than 10 pack years.
Patients who have had an asthma attack/exacerbation requiring a short burst
of SCSs for at least 3 continuous days within 6 weeks prior to Visit 1
Patients who have had a respiratory tract infection within 4 weeks prior to
Visit 1
History of life-threatening asthma in the previous ten years
History or active of chronic lung diseases other than asthma
Pregnant or nursing (lactating) women
Women of child-bearing potential without effective contraception methods |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of exacerbations within 52 weeks in atopic patients |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Number of exacerbation in all patients (atopic and non-atopic)
Number of exacerbations in non-atopic patients
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 94 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belgium |
Brazil |
Canada |
Chile |
Colombia |
Czech Republic |
Denmark |
France |
Germany |
Greece |
Guatemala |
Hungary |
India |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Netherlands |
Norway |
Panama |
Peru |
Poland |
Russian Federation |
Slovakia |
Slovenia |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Completion of the study in general will be when all randomized have completed the 20 weeks follow-up period (Visit 303) or have prematurely withdrawn. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |