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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001705 |
E.1.2 | Term | Allergic 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 demonstrate the efficacy of ACT-129968 versus placebo on lung function. |
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E.2.2 | Secondary objectives of the trial |
- To explore the efficacy of different doses of ACT-129968 on lung function and symptoms of asthma.
- To assess the tolerability and safety of ACT-129968.
- To assess the pharmacokinetics (PK) of ACT-129968. |
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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 |
A pharmacokinetic-cardiac monitoring (PK-CM) sub-study of approximately 120 patients will be conducted at selected centers.
In addition to cardiac monitoring and ECG, the pharmacokinetic profile of ACT-129968 will be determined.
Another DNA testing sub-study will be performed to explore genetic variation in CRTH2.
The participation in both sub-studies will be optional. |
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E.3 | Principal inclusion criteria |
- Males and females aged 18 to 65 years.
- Signed informed consent prior to any study-mandated procedure.
- Women of childbearing potential must use adequate contraception.
- Presenting with a diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines.
- Partially controlled asthma while using only rescue medication as needed. |
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E.4 | Principal exclusion criteria |
- Pregnant or lactating women.
- Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced
asthma.
- History of life-threatening asthma at any time, defined as an asthma episode that
required intubation and/or was associated with hypercapnia, respiratory arrest or
hypoxic seizures.
- Any asthma exacerbation requiring treatment with systemic corticosteroids within
the last 3 months.
- Any hospital admission for asthma within the last 6 months.
- Anti-IgE therapy (at any time).
- Ongoing or recent treatment with medication for allergic airway disease (either
prescribed or over-the-counter [OTC]) other than an inhaled beta2 agonist used
solely as reliever therapy on an ‘as-needed’ basis.
- Smoking within the last year, or life-time consumption of 10 pack-years e.g., 20 cigarettes/day for 10 years.
- Treatment with investigational asthma controller biological agents (recombinant
proteins or monoclonal antibodies) within 6 months prior to start of study drug. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the change from baseline in FEV1 percentage of predicted (FEV1%oP) normal value. |
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E.5.1.1 | 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 | No |
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 | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 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 | 30 |
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 |
Australia |
Bulgaria |
Germany |
Hungary |
Israel |
Poland |
Russian Federation |
Serbia |
Singapore |
South Africa |
Sweden |
Ukraine |
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
| |
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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |