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 | 18.1 |
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 to placebo in reducing the prescribed, oral corticosteroid (OCS) maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance oral corticosteroid (OCS) in addition to inhaled corticosteroid plus long-acting β2-agonist (ICS/LABA). |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of tralokinumab compared to placebo on the proportion of subjects with the prescribed, oral corticosteroid (OCS) maintenance dose ≤5 mg in adult and adolescent subjects with asthma requiring chronic treatment with maintenance oral corticosteroids (OCS) in addition to inhaled corticosteroid plus long-acting β2-agonist (ICS/LABA).
2. To evaluate the effect of tralokinumab compared to placebo on the proportion of subjects with at least 50% reduction in their prescribed, oral corticosteroid (OCS) maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance oral corticosteroids (OCS) in addition to inhaled corticosteroid plus long-acting β2-agonist (ICS/LABA). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age 12 to 75 years
2. Documented physician-diagnosed asthma.
3. Documented treatment with Inhaled Corticosteroid (ICS) at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents and a LABA.
4. Receiving Oral Corticosteroid (OCS) for the treatment of asthma.
5. Pre-BD FEV1 value <80% (<90% for patients 12 to 17 years of age) of their predicted normal value (PNV).
6. Post-BD reversibility of ≥12% in FEV1. |
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E.4 | Principal exclusion criteria |
1. Clinically important 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) |
Percent change from baseline in the daily, average, oral corticosteroid (OCS) dose at week 40 post randomization while not losing asthma control. |
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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. Difference vs. placebo in the proportion of subjects with final daily average oral corticosteroid (OCS) dose ≤5 mg at Week 40 post randomization.
2. Difference vs. placebo in the proportion of subjects with ≥50% reduction in average daily oral corticosteroid (OCS) dose at Week 40 post randomization. |
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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 | 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 | No |
E.6.10 | Pharmacogenetic | No |
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 | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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 |
Belgium |
France |
Germany |
Netherlands |
Poland |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 23 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 23 |