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 | 16.0 |
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 the efficacy of lebrikizumab compared with placebo as measured by the rate of asthma exacerbations
To evaluate the efficacy and safety of different dose levels of lebrikizumab compared with placebo
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E.2.2 | Secondary objectives of the trial |
To evaluate change in pre-bronchodilator FEV1, time to first asthma exacerbation, change in FeNO, change in patient-reported asthma-specific health related quality of life, change in asthma rescue medication use, and rate of urgent asthma-related health care utilization during the placebo-controlled period
To evaluate the acceptability (perceived pain) of injections of lebrikizumab
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adolescent patients, 12 - 17 years of age at the time of screening and randomization
• Asthma diagnosis for >/= 12 months at Visit 1
• Bronchodilator response during screening
• Pre-bronchodilator FEV1 of 40% - 90% predicted at both Visits 2 and 3
• On high dose inhaled corticosteroid (ICS) therapy for >/= 6 months prior to Visit 1
• On an eligible second controller medication for 6 months prior to Visit 1
• Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization
• Demonstrated adherence with controller medication during the screening period. |
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E.4 | Principal exclusion criteria |
• History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
• Maintenance oral corticosteroid therapy within 3 months of Visit 1
• Treatment with systemic (oral, intravenous, or intramuscular) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
• Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
• Infection that meets the following criteria:
- Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening:
- Any active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening;
- Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening;
- Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening;
• History of active tuberculosis requiring treatment
• Known immunodeficiency, including, but not limited to, HIV infection
• Evidence of acute or chronic hepatitis or known liver cirrhosis
• History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma
• Diagnosis or history of malignancy or current evaluation for potential malignancy
• Current smoker or former smoker with a history of > 10 pack-years
• History of alcohol or drug abuse
• Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months prior to Visit 1
• Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of asthma exacerbations during the 52-week placebo-controlled period |
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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) |
1. Relative change in pre-bronchodilator FEV1 (liters)
2. Time to first asthma exacerbation
3. Change in fractional exhaled nitric oxide (FeNO)
4. Change in asthma-specific, health-related quality of life: overall score of the Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12)
5. Change in asthma rescue medication use
6. Rate of urgent asthma-related health care utilization
7. Safety: incidence of adverse events. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. from baseline to week 52
2. week 52
3 to 5. from baseline to week 52
6. 52 weeks
7. 124 weeks |
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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 | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 3 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
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 |
Brazil |
Canada |
Colombia |
Czech Republic |
France |
Germany |
Hungary |
India |
Israel |
Italy |
Korea, Republic of |
Mexico |
Peru |
Poland |
Portugal |
Russian Federation |
Serbia |
Slovakia |
South Africa |
Spain |
Taiwan |
Ukraine |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |