Treatment of seasonal grass pollen rhinoconjunctivitis. MedDRA version: 15.1 Level: LLT Classification code 10019170 Term: Hay fever System Organ Class: 100000004870
Conditions
Interventions
Product Name: gpASIT+TM
Pharmaceutical Form: Solution for injection
Sponsors
BioTech Tools S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed and dated Informed Consent Form by a legally competent patient • Female or male patients aged 18–70 years • The patients are in good physical and mental health according to his/her medical history and vital signs • Non-pregnant, non-lactating females with adequate contraception (see Annex XX.3) • Females unable to bear children must have signed the form for adequate contraceptive protection (see Annex XX.3) (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) for 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, histamine wheal = 3 mm, NaCl control reaction = 2 mm o Specific IgE against grass pollen (IgE > 0.7 kU/l) o Patients treated with anti-allergic medication for at least 2 years prior to enrolment • In asthmatic patients: o Confirmed diagnosis of controlled asthma according to GINA-guidelines (GINA 2006) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion • Previous immunotherapy with grass allergens within the last 5 years, • Ongoing immunotherapy • Patients being in any relationship or dependence with the Sponsor and/ or Investigator • Inability to understand instructions/ study documents • Patients with a history of hypersensitivity to the excipients of investigational products • Patients with partly controlled or uncontrolled asthma • Chronic asthma or emphysema, particularly with a FEV 1 37.5°C, oral) • Patients with a known positive serology for HIV-1/2, HBV or HCV • Patients who are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry • Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (see Annex XX.3) • Consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 3 weeks preceding the trial (screening visit) • Patients with laboratory values greater than grade 1 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) • Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial in patients suffering from hay fever is the assessment of the safety and clinical tolerability of increasing doses of gpASIT+TM when administered by subcutaneous injections, in order to determine the maximal tolerated dose.;Secondary Objective: The secondary objectives of this trial are the assessment of the immunogenicity of increasing doses of gpASIT+TM administered subcutaneously and the comparison of the reaction to Conjunctival Provocation Test (CPT) performed before and after treatment as well as at Visit V5 ;Primary end point(s): The possible adverse reactions will be investigated by the systematic recording at predetermined time points of - general physical status, vital signs - solicited local adverse events, unsolicited adverse events, serious adverse events - haematological parameters - routine blood chemistry parameters - immunological analysis - inflammatory parameters - urinanalysis;Timepoint(s) of evaluation of this end point: - general physical status, vital signs (visit 1 to 8) - solicited local adverse events, unsolicited adverse events, serious adverse events (visit 2 to 8) - haematological parameters (visit 1 and 8) - routine blood chemistry parameters (visit 1 and 8) - immunological analysis (visit 1 and 8) - inflammatory parameters (visit 1 and 8) - urinanalysis (visit 1 and 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Theses will be performed before and after treatment as well as at visit 6;Secondary end point(s): The secondary objectives of this trial are the assessment of the immunogenicity of increasing doses of gpASIT+TM administered subcutaneously and the comparison of the reaction to Conjunctival Provocation Test (CPT) | — |
Countries
Germany
Contacts
Public ContactContract Research Organisation
Institut für Medizinische Statistik, Informatik und Epidemiologie
Outcome results
None listed