E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Grass pollen induced allergic rhinoconjunctivitis requiring treatment during the grass pollen season |
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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 |
Comparison of two updosing schedules with respect to the pharmacodynamic efficacy regarding changes from baseline in spec. IgE-blocking factor against Phleum pratense after seven injections of the IMP (ALK-Flex SQ) |
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E.2.2 | Secondary objectives of the trial |
To compare both groups with respect to incidences of delayed systemic adverse events (1-24 hrs) in Group 1 and Group 2 classified as 'urticaria' and/or 'asthma' according to EAACI.
To compare both groups with respect to incidences of early adverse events (0-60 min) in Group 1 and Group 2, graduated according to EAACI and classified according to MedDRA version 11.0.
To compare both groups with respect to changes from baseline in spec. IgG4 against Phleum pratense 1 week after the 7th injection of the IMP (ALK-Flex SQ).
To compare both groups with respect to changes from baseline in spec. IgE against Phleum pratense 1 week after the 7th injection of the IMP (ALK-Flex SQ).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
Lack of adequate relief with symptomatic medication during the previous pollen season
Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter ≥ 3 mm) currently performed or not older than 60 days before screening.
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E.4 | Principal exclusion criteria |
FEV1 < 70% of predicted value at screening
Bronchial asthma corresponding to GINA step 3 or more, even if controlled
History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months
Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ 4 grass mix + rye.
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes from baseline in specific IgE-blocking factor measured 1 week after the 7th injection will be the only primary endpoint of this study. Equivalence of the updosing schedules Group 1 and Group 2 will be tested with a prespecified equivalence margin. |
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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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Two different administration schedules of the same IMP |
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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 | 50 |
E.8.5 | The trial involves multiple Member States | No |
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 | 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
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Follow-up Visit 1 week after the 7th injection |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |