| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| MedDRA Classification |
| 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 of specific immunotherapy with the 75,000 SQ-T ALK Grass tablet compared to placebo in subjects with grass pollen induced rhinoconjunctivitis, based on the rhinoconjunctivitis symptom score as well as the rhinoconjunctivitis medication score during the grass pollen season. | |
| E.2.2 | Secondary objectives of the trial | To evaluate the efficacy of specific immunotherapy with the 75,000 SQ-T ALK Grass tablet compared to placebo in subjects with grass pollen induced rhinoconjunctivitis based on:
Rhinoconjunctivitis medication score in the grass pollen season.
Rhinoconjunctivitis symptom and medication score in the peak grass pollen season.
Rhinoconjunctivitis and asthma symptom score and medication score in the entire and peak grass pollen season.
Asthma symptom score and medication score in the entire and peak grass pollen season.
Rhinoconjunctivitis by VAS in the grass pollen season and peak grass pollen season.
QoL , Pharmacoeconomics and Number of well days in the grass pollen season
Global evaluation of rhinoconjunctivitis symptoms.
Impact of pre-seasonal treatment on rhinoconjunctivitis symptom and medication score during the entire and peak grass pollen season.
Safety and tolerability of the 75,000 SQ-T ALK Grass tablet compared to placebo.
| |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | •Male and female 18-65 years of age who have given informed consent, with the following selection criteria:
•Written informed consent obtained before entering the trial
•A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
•A clinical history of severe rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep), which remain troublesome despite treatment with antiallergic drugs during the grass pollen season
•Positive Skin Prick Test (SPT) response (wheal diameter ≥ 3 mm) to Phleum pratense
•Positive specific IgE against Phleum pratense (≥ IgE Class 2)
•Physical examination with no clinically relevant findings
•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
•Willingness to comply with this protocol
Adequate contraception methods include: male sterilisation by vasectomy for at least 6 months; condom + spermicide; diaphragm + spermicide; intra-uterine contraceptive device placed at least 4 weeks prior to trial drug administration); oral contraceptives (starting at least 4 weeks prior to trial drug administration); implant (e.g. Norplant - starting at least 4weeks prior to trial drug administration); depot injection of a progestogen drug (e.g. Depo-Provera - starting at least 4 weeks prior to trial drug administration)
| |
| E.4 | Principal exclusion criteria | •FEV1 < 70% of predicted value
•A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of – and potentially overlapping - the grass pollen season
•A clinical history of significant symptomatic perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed
•A clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis
•At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media is not an exclusion criterion)
•History of emergency visit or admission for asthma in the previous 12 months
•Use of an investigational drug within 30 days prior to screening
•Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
•History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
•History of angioedema
•Any of the following underlying conditions known or suspected to be present:
Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal or hepatic insufficiency, chronic infection, drug dependency or alcoholism
ischemic heart disease or angina requiring current daily medication or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric,
endocrine, or other major systemic disease)
•Immunosuppressive treatment
•History of hypersensitivity to the excipients of the trial medications
•History of allergy, hypersensitivity or intolerance to trial medications or rescue medications
•A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude
•Unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the grass pollen season
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| E.5 End points |
| E.5.1 | Primary end point(s) | | The primary efficacy endpoints are the average rhinoconjunctivitis symptom score as well as the average rhinoconjunctivitis medication score. These two average scores will be calculated for each subject as the sum of the daily score throughout the entire grass pollen season, divided by the duration of the grass pollen season. | |
| 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 | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| 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.8.6 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 | Information not present in EudraCT |
| 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 | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
