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 | 17.0 |
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 |
The primary objectives of this study are to evaluate the efficacy and safety of MEMP1972A in adult patients with allergic asthma inadequately controlled despite high dose inhaled corticosteroids ( ICS) (≥ 400 μg/day total daily dose of fluticasone propionate [FP] or equivalent) and a second controller after 36 weeks of treatment. |
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E.2.2 | Secondary objectives of the trial |
• To compare the efficacy and safety profiles of three dosing regimens of MEMP1972A in patients with asthma not controlled on high dose ICS and a second controller
• To evaluate the pharmacokinetics of MEMP1972A |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
DNA REPOSITORY SUBSTUDY IN ASSOCIATION WITH MEMP1972A STUDY GB27980. Protocol number: GB27980 (DNA Substudy); Protocol Version 1, dated 13th February |
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E.3 | Principal inclusion criteria |
- Age 18-75 years
- Body weight ≥ 40 kg
- Normal CXR
- Diagnosis of asthma for at least 12 months
- Evidence of documented bronchodilator reversibility
- Prebronchodilator FEV1 ≥ 40% and ≤ 80% predicted
- Daily use of ICS and second controller for a minimum of 3 consecutive months prior to screen
- History of at least one protocol-defined asthma exacerbation in the 18 months prior to screen
- Inadequately controlled asthma despite compliance with asthma controller therapy documented by daily diary and ACQ
- Positive aeroallergen-specific IgE OR a total serum IgE ≥ 75 IU/mL |
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E.4 | Principal exclusion criteria |
- Asthma exacerbation requiring systemic steroids in the 30 days prior to randomization
- Have pre-existing active lung disease other than asthma
- Any infection including chronic or latent infections or infections requiring treatment during screening
- Clinically significant medical disease that is uncontrolled despite treatment
- Any condition that contraindicates the use of an investigational drug
- History of significant exposure to water-borne parasites and/or have recent diarrheal illness of indeterminate etiology
- Former smoker with >10 pack year history or current smoker
- History of anaphylaxis or allergic reaction during the use of a monoclonal antibody
- Use of any excluded concomitant therapies
- Men and women who are not willing to use highly effective method of contraception
- Women who are pregnant or lactating |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of protocol-defined asthma exacerbations resulting in use of systemic steroids or hospitalization over 36 weeks |
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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) |
- Incidence and severity of treatment-emergent adverse events
- Change in asthma symptoms |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- From consent through last study visit
- Baseline through week 36 |
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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 | No |
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 | 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
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 |
Canada |
Germany |
Hungary |
Mexico |
New Zealand |
Peru |
Poland |
Romania |
Russian Federation |
Ukraine |
United States |
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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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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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |