E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
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 effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo, on allergen-specific Ig levels in nasal secretion during 2 consecutive treatment years. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate if changes in Ig levels in nasal secretion upon immunotherapy with the hypoallergenic vaccine BM32 or placebo are associated with changes in serum Ig levels • To evaluate if changes in Ig levels in nasal secretion upon immunotherapy with the hypoallergenic vaccine BM32 or placebo are associated with changes in recorded Symptom-Score (SS) and Medication-Score (MS) • To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo on the presence of immune cells in nasal secretions • To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo on the cytokine pattern in nasal secretions
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Positive history of grass pollen allergy, positive skin prick test reaction to grass pollen extract, grass pollen allergen-specific IgE and rPhl p 1/rPhl p 5-specific IgE (at least 3.5 kUA/L) at the screening visit of CS-BM32-003 or within 12 months prior to the screening visit of CS-BM32-003 • Moderate to severe symptoms of grass pollen allergy during pollen peak in the baseline period of CS-BM32-003 • Age between 18 and 60 years (m/f) • Subjects must have a standard health care insurance • Subjects must appear capable to understand and comply with all relevant aspects of the study protocol • Subject must be available during the study period to complete all treatments and assessments • Participation in the study CS-BM32-003 (EK 1104/2012) • Willingness to comply with the study protocol and written informed consent
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E.4 | Principal exclusion criteria |
• Symptomatic perennial allergies • Atopic dermatitis • Pregnangy or breast feeding • Women with childbearing potential who are not using a medically accepted birth control method • Autoimmune diseases, immune defects including immuno-suppression, immune-complex-induced immunopathies • Contra-indication for adrenaline • Severe general maladies, malignant disease • Patients under long-term treatment with systemic corticosteroids, immunosuppressive drugs, tranquilizers or psychoactive drugs • Contra-indications for skin prick testing such as: skin inflammation in the test area, urticaria factitia • Asthma not controlled by low dose corticosteroids • Chronic use of beta-blockers • Participation in a pollen SIT trial in 2 years prior to the study • Patients who had a previous grass pollen SIT • Risk of non-compliance with the study procedure and restricitions • Use of prohibited medication prior to screening of study CS-BM32-003 and throughout the study o Depot corticosteroids – 12 weeks prior to screening of study CS-BM32-003 o Oral corticosteroids – 8 weeks prior to screening visit o High-dose inhaled corticosteroids – 4 weeks prior to screening • Use of anti-histamines three days prior to the visits where a skin prick test is performed
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes on allergen-specific Ig levels in nasal secretions |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Treatment year one: • Visit 1: before the 1st pre-seasonal vaccination • Visit 2: after the 3rd pre-seasonal vaccination • Visit 3: in the middle of the grasspollen season • Visit 4: 2 weeks after the end of the grass pollen season Treatment year two: • Visit 5: before the 1st pre-seasonal vaccination (5th vaccination) • Visit 6: after the 3rd pre-seasonal vaccination (7th vaccination) • Visit 7: in the middle of the grasspollen season • Visit 8: 2 weeks after the end of the grass pollen season
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E.5.2 | Secondary end point(s) |
• Association of changes in Ig levels in nasal secretion upon immunotherapy with the hypoallergenic vaccine BM32 or placebo with changes in serum Ig levels • Association of canges in Ig levels in nasal secretion upon immunotherapy with the hypoallergenic vaccine BM32 or placebo with changes in recorded Symptom-Score (SS) and Medication-Score (MS) • Association of the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo on the presence of immune cells in nasal secretions • Association of the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo on the cytokine pattern in nasal secretions
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Treatment year one: • Visit 1: before the 1st pre-seasonal vaccination • Visit 2: after the 3rd pre-seasonal vaccination • Visit 3: in the middle of the grasspollen season • Visit 4: 2 weeks after the end of the grass pollen season Treatment year two: • Visit 5: before the 1st pre-seasonal vaccination (5th vaccination) • Visit 6: after the 3rd pre-seasonal vaccination (7th vaccination) • Visit 7: in the middle of the grasspollen season • Visit 8: 2 weeks after the end of the grass pollen season
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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 | No |
E.6.5 | Efficacy | No |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
basic research - information on how Ig levels change in nasal secretions during immunotherapy |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |