E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Grass pollen induced rhinoconjunctivitis |
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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 | 10039097 |
E.1.2 | Term | 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 |
The primary objective of the trial is to investigate the pharmacodynamic efficacy of Grazax® compared to placebo when treatment is initiated during season, based on IgE blocking antibodies. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the trial are to investigate the pharmacodynamic efficacy of Grazax® compared to placebo when treatment is initiated during season, with respect to other immunological assessments and toevaluate the tolerability of Grazax® treatment compared to placebo when initiated during the grass pollen season. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms, which remain troublesome despite treatment with anti-allergic drugs during the GPS of two years or more
- A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms during GPS causing symptoms more the 4 days per week (for > 4 weeks)
- A clinical history of significant persistent rhinoconjunctivitis symptoms during GPS causing least one of the a-d symptoms a. Abnormal sleep b. Impairment of daily activities, sports, leisure c. Impaired work and school d. Troublesome symptoms
- Positive specific IgE against Phleum pratense (≥ IgE Class 2)
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E.4 | Principal exclusion criteria |
- Uncontrolled asthma in the past 12 months
- FEV1 < 70% of predicted value after adequate pharmacologic treatment
- Inflammatory condition in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis
- History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
- History of facial angioedema in GPS or presence of facial angioedema at time of randomization
- History of swallowing difficulties in GPS or presence of swallowing difficulties at time of randomization
- History of allergy symptoms in the GPS leading to hospital admission
- History of allergy symptoms in the GPS leading to treatment with corticosteroids other than topical corticosteroids
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E.5 End points |
E.5.1 | Primary end point(s) |
To investigate the pharmacodynamic efficacy of Grazax® compared to placebo when treatment is initiated during season, based on IgE blocking antibodies (e.g to demonstrate a lower level of IgE blocking antibodies at visit 4 (approximately 8 weeks after treatment initiation) as compared to placebo)
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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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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.8.3 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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End of trial is defined as database closure. |
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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 | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |