E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
seasonal allergic rhinoconjunctivitis |
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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 |
The primary objective of this clinical trial in allergic patients is : • the assessment of the safety of gpASIT+TM.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this trial are • the study of its impact on the immunological status of the subjects, • the study of the impact of gpASIT+TM on the clinical status of the subjects, • to determine if the efficacy of gpASIT+TM is dose related.
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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 Female 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: o A history of 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 (RAST class 2 or IgE > 0.7 kU/l) o Asymptomatic to perennial inhalant allergens.
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E.4 | Principal exclusion criteria |
• Subjects with current or past immunotherapy (any time in the past) • Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids) • Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator) • Subjects with a history of hepatic or renal disease • Subjects symptomatic to perennial inhalant allergens • Subject with malignant disease, autoimmune disease • Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD) • Any chronic disease, which may impair the subject’s ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, 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) • Subject with febrile illness (> 37.5°C, oral) • A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies • The subject is immunocompromised by medication or illness, has 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 • 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 • 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 • Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start • A history of hypersensitivity to the excipients • Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…) • Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator • Subjects who participated to trial BTT-gpASIT002
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the trial is to demonstrate clinical tolerability and safety of gpASIT+TM: the possible adverse reactions will be investigated via recording of • general physical status, vital signs (heart rate and blood pressure), • haematological parameters (hemoglobin, hematocrit, RBC, WBC including differential counts and platelets), • general blood biochemistry parameters, • all adverse events, serious adverse events, • immunological analysis (total IgE and IgG levels, anti-nuclear antibodies (ANA) and Rheumatoid Factor (RF)), • inflammatory parameters (C-Reactive protein (CRP), blood sedimentation rate).
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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 | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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 | 4 |
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 | 11 |
E.8.9.1 | In the Member State concerned days | |