Treatment of seasonal grass pollen rhinoconjunctivitis MedDRA version: 12.1 Level: LLT Classification code 10019170 Term: Hay fever
Conditions
Interventions
Product Name: gpASIT+TM
Product Code: gpASIT+TM 400 µg
Pharmaceutical Form: Gastro-resistant capsule, soft
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: POL2
Other descriptive name: Pol
Sponsors
Biotech Tools sa
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;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. | — |
Countries
Belgium
Outcome results
None listed