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 |
The primary objective of the trial is to demonstrate the pharmacodynamic efficacy of specific immunotherapy with intraseasonal updosing compared to placebo in subjects with grass pollen induced rhinoconjunctivitis, based on IgX, i.e.: To demonstrate a lower level of IgX at Visit 9, approximately 9 weeks after start of updosing (i.e. approximately 2 weeks after the 8th injection), as compared to placebo.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the trial are: ● To demonstrate the pharmacodynamic efficacy of specific immunotherapy with intraseasonal updosing compared to placebo with respect to 1. IgX measured at Visits 6 and 7 2. IgG4 measured at Visits 6, 7, and 9, i.e.:
To demonstrate a lower level of IgX at Visits 6 and 7, approximately 1 and 3 weeks after start of updosing, as compared to placebo. AND To demonstrate a higher level of IgG4 at Visits 6, 7, and 9 approximately 1, 3, and 9 weeks after start of updosing, as compared to placebo.
● To demonstrate a lower nasal reactivity against challenge with Phleum pratense measured at study end with the titrated nasal provocation test as compared to placebo.
● To demonstrate a lower skin reactivity against challenge with Phleum pratense measured at study end with the titrated skin prick test as compared to placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Male and female patients 18-65 years of age who have given informed consent, with the following selection criteria: • A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season • Positive Skin Prick Test (SPT) response to grass pollen Phleum pratense (wheal diameter ≥ 3 mm) currently performed or not older than 60 days before V1 • If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the trial.
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E.4 | Principal exclusion criteria |
• Not controlled or severe bronchial asthma • Anamnestically known high degree of sensitivity against grass pollen • Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years • Autoimmune disorders • Exclusion criteria in accordance with contraindications in the SPC of Alutard SQ 6 grass mix + rye (secale) (= ALK-depot SQ Gräsermischung und Roggen). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunological changes from baseline in spec. IgX against Phleum pratense after 9 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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 16 |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |