E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal rhino-conjunctivitis due to grass pollen allergy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001728 |
E.1.2 | Term | Allergic rhinoconjunctivitis |
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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 and safety of orally administered MGPE compared with placebo when dosing is initiated at least 8 weeks prior to and continuing throughout the grass pollen season in grass allergic subjects. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the treatment effect of MGPE on: average daily TSS during the grass pollen season, concomitant relief medication-adjusted TSS, concomitant relief medication usage, Rhino-conjunctivitis quality of life, global allergy evaluation score, average daily nasal and non-nasal symptom scores, individual symptom scores, proportion of days with minimal symptoms and no concomitant medication used to relieve allergy symptoms and serum immunoglobulin levels of grass specific IgG, IgG4 and IgE. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Have signed the informed consent. Have a history of two consecutive seasons of moderate to severe seasonal allergic rhinitis in the period May to July that has required repeated treatment e.g. antihistamines, leukotriene antagonists, nasal steroids and topical cromones. Have a positive skin prick test to a standardised grass pollen extract (diameter of the wheal must be the same size as the positive control or longest diameter 5mm) Have a grass specific IgE level of at least 0.7kU/L using the Phadia ImmunoCAP assay. Have a positive nasal provocation test. Will be available for clinic visits for the duration of the study. Aged 18-65 |
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E.4 | Principal exclusion criteria |
Are pregnant and/or breastfeeding Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the efficacy or the safety of the study medication or might place the subject at additional risk. Have medical conditions in which the administration of adrenaline is contraindicated (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension) Have chronic infections Have moderate to severe perennial or structurally related rhinitis, including vasomotor rhinitis. Have a routine sleeping pattern between the hours of 6.00am to 6.00pm (i.e. night workers). Are currently receiving immunotherapy to any allergens and/or have received grass immunotherapy within 3 years of the Screening Visit. Have insufficiently treated asthma and/or irreversible airway obstruction with a value of forced FEV1<70% of the predicted value despite treatment with asthma medication. Have moderate to severe persistent asthma (GINA criteria III and IV). Will travel outside a grass pollen region during the grass pollen season (May 1-July 15) for more than 3 consecutive days or for more than a total of 7 days. Have been legally institutionalized |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy measure will be the average daily Total Symptom Score (TSS) of six symptoms during the 3 contiguous peak grass pollen weeks or the grass pollen season if the peak season is less than 3 weeks. |
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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 | No |
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) | 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.8.3 |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 70 |
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 | Information not present in EudraCT |
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 |
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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
|
The end of the study is defined as a database lock, which is the time point after which no subject will be exposed to study-related activities. |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |