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 |
Asthma is a chronic condition which causes narrowing and inflammation of the airways and breathing difficulty |
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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 | LLT |
E.1.2 | Classification code | 10003560 |
E.1.2 | Term | Asthma NOS |
E.1.2 | System Organ Class | 100000004855 |
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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 MTPS9579A compared with placebo |
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E.2.2 | Secondary objectives of the trial |
•To evaluate the safety and other measures of efficacy of MTPS9579A compared with placebo
•To evaluate the pharmacokinetics of MTPS9579A
•To evaluate the immune response to MTPS9579A
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Ability to comply with the study protocol, in the investigator's judgment
- Age 18-75 years
- Documented physician-diagnosed asthma
- Pre-bronchodilator FEV1 40%-80% predicted at screening
- On inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication
- Documented history of >= 2 asthma exacerbations within the 12 months prior to screening while on daily ICS maintenance therapy
- Use of contraceptive measures |
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E.4 | Principal exclusion criteria |
- Diagnosis of mimics of asthma or significant respiratory disease other than asthma
- Recent history of smoking
- Pregnant, lactating, or intending to become pregnant during the study or within 120 days after the last dose of the investigational medical product
- Comorbid conditions that may interfere with the evaluation of an investigational medical product
- Known sensitivity to any of the active substances or their excipients to be administered during dosing
- History or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
- Asthma exacerbation within 4 weeks prior to screening
The above information is not intended to contain all considerations relevant to a patient’s participation in this clinical trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Time to first event, defined as a composite of asthma exacerbation or diary worsening, during the double-blind treatment period |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. From treatment start through Week 50 |
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E.5.2 | Secondary end point(s) |
1.Rate of asthma exacerbations during the double-blind treatment period
2.Time to first asthma exacerbation during the double-blind treatment period
3.Change from randomization in pre-bronchodilator FEV1
4.Change from randomization in FeNO
5.Incidence and severity of adverse events, with severity determined according to the World Health Organization Toxicity Grading Scale
6.Change from randomization visit in physical examination findings, vital signs, ECG parameters, clinical laboratory results
7.Serum concentration of MTPS9579A at specified timepoints
8.Prevalence of anti-drug antibodies (ADAs) during the study |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-2. Up to Week 50
3-4. From treatment start through Week 50
5. Up to 67 weeks
6. From treatment start through Week 54
7. Week 2, Week 3, Week 6, Week 10, Week 14, Week 22, Week 30, Week 38, Week 50, Week 54, unscheduled visit and early termination visit
8. Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 54, unscheduled visit and early termination visit |
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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 | No |
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 |
Immunogenecity, Biomarker & exploratory |
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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) | 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 | No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
Germany |
Peru |
Poland |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |