E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic rhinitis and/or allergic rhinoconjunctivitis with or without intermittent asthma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001726 |
E.1.2 | Term | Allergic rhinitis due to pollen |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001728 |
E.1.2 | Term | Allergic rhinoconjunctivitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 assess the effective dose range and the optimum dose after one year of treatment with Depigoid® Phleum administered subcutaneously in adult subjects with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of different doses of Depigoid® Phleum administered subcutaneously during a one-year treatment period. To assess the impact of pre-seasonal treatment with different doses of Depigoid® Phleum administered subcutaneously on the conjunctival provocation test (CPT) in adult subjects with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma. To assess the impact of a one year treatment with Depigoid® Phleum administered subcutaneously on the skin reactivity to a Phleum allergen extract at different concentrations administered with the titrated skin prick test (tSPT). To assess the impact of a one year treatment with Depigoid® Phleum administered subcutaneously on the Health Related Quality of Life of adult subjects with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject must be ≥ 18 years and ≤ 70 years of age. 2. Subject is either male or female. 3. Subject must have a perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS). 4. Subject must have a forced expiratory volume in the first second (FEV1) or a peak expiratory flow rate (PEFR) value > 80% of predicted normal value. 5. Subject must complain about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years, with or without intermittent asthma symptoms, caused by clinical sensitisation against grass pollen. The IgE-mediated sensitisation must be verified by the following: suggestive medical history AND specific IgE against Phleum pollen radioallergosorbent test (RAST) ≥ 2 AND a positive skin prick test (SPT) AND a positive CPT for grass pollen. A SPT is considered positive when the test results in a wheal diameter of at least 3 mm and at least the size of the positive control. A CPT is deemed to be positive if a score of 5 is achieved with any one of the following concentrations: 100, 330, 1,000, 3,300 or 10,000 SQ-U/mL. 6. Female subject who is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, e.g. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy 7. Female subject of childbearing potential must be non-lactating and non-pregnant (with a negative pregnancy test at Visit 1). The female subject must use correctly an effective method of contraception during the study. An effective method of contraception is defined as one that results in less than 1% per year of rate failure. The following are allowed methods of contraception when continuously and properly used: hormonal contraceptives by implants, injections or oral, complete abstinence, partner’s vasectomy only if single partner. Barrier methods (e.g., preservatives) are only effective if used together with one of the above. 8. Subject is able to provide written informed consent to participate in the trial and able to understand the procedures and trial requirements. 9. Subject has completed at least 5 of 7 days of the subject’s diary card during the week prior to Visit 2.
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E.4 | Principal exclusion criteria |
1. Subject has a history of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial allergens (e.g., house dust mites), including those: a) with typical symptoms against co-allergens like trees or weed pollen, house dust mites, cat and dog, b) sensitised to birch or other trees (positive SPT or specific IgE RAST ≥ 2).
N.B.: a) Subjects who are sensitised against pets and do not have symptoms may enter into the trial if they are not exposed to the allergen, even if the specific IgE RAST is ≥ 2. In case they are exposed to the allergen, they must have a specific IgE RAST < 2 to be able to be enroled into the trial. b) Subjects who are sensitised against house dust mites and do not have symptoms may enter into the trial if the specific IgE RAST is ≤ 2. 2. Subject has persistent asthma, according to Global Initiative for Asthma (GINA) Guidelines. 3. Subject has acute or chronic inflammatory or infectious diseases of the airways, sinuses or the conjunctiva. 4. Subject has chronic structural diseases of the lung (e.g., emphysema or bronchiectasis). 5. Subject has diseases of the immune system, both autoimmune and immune deficiencies. 6. Subject has any disease that prohibits the use of adrenaline (e.g. hyperthyroidism). 7. Subject has severe uncontrolled diseases that could increase the risk of the subjects participating in the study, which include, but are not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders. 8. Subject has had active malignant disease during the previous 5 years. 9. Subject has a significant abnormal laboratory parameter or alteration in the vital signs that could increase the risk to the study subject. 10. Subject has had alcohol, drug or medication abuse within 12 months prior to Visit 1. 11. Subject has severe psychiatric, psychological or neurological disorders. 12. Subject has used immunotherapy against grass pollen with comparable extracts within the last five years. 13. Subject has used systemic and/or topical treatment with β-blockers within 1 week prior to Visit 2. 14. Subject has used any medication that interferes with the immune system within 1 week prior to Visit 2. 15. Subject has used tranquiliser or psychoactive drugs within 1 week prior to Visit 1. 16. Subject has used systemic corticosteroids within 3 months prior to Visit 1. 17. Subject has been immunised with vaccines within 1 week prior to Visit 2. 18. Subject has hypersensitivity to excipients of the investigational medicinal product. 19. Subject is expected to be non-compliant and/or not co-operative. 20. Subject has participated in another clinical study within 30 days prior to Visit 2. 21. Subject has already participated in this study. 22. Subject is an employee at the investigational centre or 1st degree relative or partner of the investigator. 23. Subject plans to donate germ cells, blood, organs, or bone marrow during the course of the study. 24. Persons who are jurisdictionally or governmentally institutionalized.
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of subjects who need an increased amount of allergen to elicit a positive CPT performed after the pollen season in comparison to baseline. |
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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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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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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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |