E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of seasonal grass pollen rhinoconjunctivitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019170 |
E.1.2 | Term | Hay fever |
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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 this clinical trial is to assess the effect of a 28-day treatment with 2 different doses of gpASIT+TM compared with placebo on the reduction of the rhinoconjunctivitis scores and use of rescue medication in adults suffering from moderate to severe grass pollen allergic rhinitis rhinoconjunctivitis. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the trial are • To assess the impact of gpASIT+TM on the immunological status of the subjects in comparison with placebo, • To assess the safety and clinical tolerability of gpASIT+TM.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subject has given written informed consent • Age between 18 and 50 years • The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status • Male or non pregnant, non-lactating female • Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period)) • Allergy diagnosis: o A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years o A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture o Specific IgE against grass pollen (IgE > 0.7 kU/l) o Asymptomatic to perennial inhalant allergens • Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2008 and who had moderate to severe symptoms during the last two years • Subjects with seasonal asthma are allowed to be included
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E.4 | Principal exclusion criteria |
• Subjects with current immunotherapy and subjects who underwent an immunotherapy within the last 2 years • Participation in another clinical trial and/or treatment with an experimental drug within the last 2 years • A history of hypersensitivity to the excipients • Subjects with perennial asthma. • Subjects requiring control medication against asthma from step 2 according to GINA classification (ref. is made to Appendix 5) • Subjects with an VC < 80% and a FEV1 < 70% of predicted value • Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator) • Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…) • Subjects symptomatic to perennial inhalant allergens • Subjects with a history of hepatic or renal disease • Subject with malignant disease, autoimmune disease • Any chronic disease, which may impair the subject’s ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc…) • Subjects requiring beta-blockers medication • Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants) • Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial • Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial • Use of long-acting antihistamines • Subject with febrile illness (> 37.5°C, oral) • A known positive serology for HIV-1/2, HBV or HCV • Subjects that are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry • Receipt of blood or a blood derivative in the past 6 months preceding trial entry • Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (i.e. OCs, IUD, V-rings and contraceptive implants) • Any condition which could be incompatible with protocol understanding and compliance • Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship • Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol • Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: • The primary endpoint is the reduction of rhinoconjunctivitis total symptom scores (RTSS) in the treated groups in comparison with the placebo group.
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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 | Yes |
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 | 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 |
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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.8.3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |