E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Asthma |
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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 | 20.0 |
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 effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma |
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E.2.2 | Secondary objectives of the trial |
Secondary: - to assess the PK and immunogenicity
Safety: - to assess the safety and tolerability of tezepelumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Documented physician-diagnosed asthma for at least 12 months prior to Visit 1. - Morning pre-bronchodilator FEV1 (Forced expiratory volume) of > 50% predicted normal value at Visit 1 or Visit 2. - Body weight ≥ 40 kg. - For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3. - Must have 'not well-controlled' asthma. |
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E.4 | Principal exclusion criteria |
- Clinically important pulmonary disease other than asthma. - Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment. - Life-threatening asthma. - History of cancer. - Allergy to eggs, if egg based influenza vaccine will be administered. - History of anaphylaxis to any biologic therapy. - Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible. - History of alcohol or drug abuse within 12 months prior to the date of informed consent. - Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures during the conduct of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Post-vaccination strain-specific hemagglutination-inhibition (HAI) antibody geometric mean fold rises (GMFRs) from Week 12 (pre-vaccination antibody measure) to Week 16 (EOT). - Post-vaccination strain-specific microneutralization (MN) antibody GMFRs from Week 12 (pre-vaccination antibody measure) to Week 16 (EOT). - Post-vaccination strain-specific serum HAI antibody geometric mean titers (GMTs) obtained at Week 16 (EOT). - Post-vaccination strain-specific serum MN antibody GMTs obtained at Week 16 (EOT). - Post-vaccination strain-specific antibody response at Week 16 (EOT) with antibody response defined as a ≥ 4-fold rise in HAI antibody titer from Week 12 (pre-vaccination antibody measure) to Week 16 (EOT). - Post-vaccination strain-specific antibody response at Week 16 (EOT) with antibody response defined as a ≥ 4-fold rise in MN antibody titer from Week 12 (pre-vaccination antibody measure) to Week 16 (EOT). - Post-vaccination strain-specific HAI antibody titer ≥ 40 at Week 16 (EOT). - Post-vaccination strain-specific MN antibody titer ≥ 40 at Week 16 (EOT). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Week 12 (pre-vaccination antibody measure) to Week 16 (EOT)
Week 16 (EOT) |
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E.5.2 | Secondary end point(s) |
Secondary: - serum trough tezepelumab concentrations - anti-drug antibodies |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 0, 12, 16, and 28
Baseline to Week 28 |
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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 | No |
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 | 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) | 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 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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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The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure for the last participant in the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 25 |