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 | 17.1 |
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 effect of tralokinumab compared with placebo on the annualised asthma exacerbation rate in adult and adolescent subjects with asthma that is inadequately controlled with inhaled corticosteroid plus long-acting β2-agonist |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of tralokinumab with regards to lung function
To assess the effect of tralokinumab with regards to asthma symptoms
To assess the effect of tralokinumab with regards to asthma specific health-related quality of life
To assess the effect of tralokinumab with regards to ACQ-6 defined asthma control
To assess the effect of tralokinumab with regards to ER and urgent care visits and hospitalizations due to asthma
To assess the effect of tralokinumab with regards to health care resource utilization and productivity loss due to asthma
To assess the effect of tralokinumab with regards to health related quality of life
To assess the effect of tralokinumab with regards to asthma symptoms and asthma control
To evaluate the PK and immunogenicity of tralokinumab
To evaluate the safety and tolerability tralokinumab
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age 12 -75
2. Documented physician-diagnosed asthma.
3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV.
5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1
6. ACQ-6 score ≥1.5 |
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E.4 | Principal exclusion criteria |
1. Pulmonary disease other than asthma
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant or breastfeeding
5. History of cancer
6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
7. Previous receipt of tralokinumab |
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E.5 End points |
E.5.1 | Primary end point(s) |
Annual asthma exacerbation rate |
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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.Percent change from baseline to Week 52 in pre-dose/pre-bronchodilator forced expiratory volume in 1 second
2. Change from baseline to Week 52 in daily asthma symptom score
3. Change from baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older total score
4. Change from baseline to Week 52 in Asthma Control Questionnaire-6 defined asthma control
5. Time to first asthma exacerbation and proportion of subjects with ≥1 asthma exacerbation
6. Annualised asthma exacerbation rate that is associated with an ER or urgent care visit, or a hospitalization
7. Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire and European Quality of Life - 5 Dimension 5 Level Daily Living Questionnaire
8. Rescue medication use, Home peak expiratory flow (morning and evening)
9. Night-time awakening due to asthma
10. Pharmacokinetic parameters and Anti-Drug Antibodies
11. Safety and Tolerability of tralokinumab assessed by the reporting of adverse events/serious adverse events and assessments for physical examination, electrocardiogram, laboratory values and vital signs |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 0 to Week 52
- endpoints 1-9
Week 0 to Week 72
- endpoints 10-11 |
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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 | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | 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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 82 |
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 |
Belgium |
Brazil |
Bulgaria |
Colombia |
Germany |
Hungary |
Korea, Republic of |
Peru |
Poland |
Slovakia |
Spain |
United States |
Vietnam |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 28 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 28 |