Treatment of seasonal grass pollen rhinoconjunctivitis MedDRA version: 16.1 Level: LLT Classification code 10019170 Term: Hay fever System Organ Class: 100000004870
Conditions
Interventions
Product Name: gpASIT+TM
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Sponsors
BioTech Tools s.a.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all the following inclusion criteria in order to participate in this study • 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 • Also females unable to bear children (i.e. tubule ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)) must have signed the form “adequate contraceptive protection”) • Allergy diagnosis: o A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) for the grass pollen season (definition of allergy severity according to ARIA (Bousquet et al 2001)) 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 0.7 kU/L. o Positive response to conjunctival provocation testing with at least 10,000 SQ-E/ml of grass allergens at both visits V1 AND V2. Additionally the difference in reacting concentration at visits V1 and V2 must not exceed one step of allergen concentration. Otherwise, the test will be considered as irregular and the patient must be excluded. In the case that there is a difference between the reactive concentrations at visit V1 and V2 the higher concentration will be assumed as baseline reactivity. • Patients treated with anti-allergic medication for at least 2 years prior to enrolment • In asthmatic patients: Confirmed diagnosis of controlled asthma according to GINA-guidelines (GINA 2012) For all patients with co-sensitizations to birch pollen allergens all of the following criteria must be fullfilled: • The result of the skin prick test to birch pollen has to be less than the result to grass pollen • The specific IgE level to birch pollen allergens has to less than the s-IgE level to grass (the CAP RAST class for grass has to be at least 1 CAP RAST class higher than the CAP RAST class to birch) • Patients with co-sensitization against birch pollen allergens must not suffer from typical rhinoconjunctivitis symptoms in spring time 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
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, CRO and/ or Investigator • Inability to understand instructions/ study documents • Patients with a history of hypersensitivity to the excipients of investigational product (gpASIT+TM or placebo) • Patients with partly controlled or uncontrolled asthma (as defined in: Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2012. Available from http://www.ginasthma.org) • Patients with 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 • Consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in VIII.6 • 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 |
|---|---|
| Primary end point(s): • The primary endpoint will be the proportion of patients in each of the four treatments groups with a reduction of reactivity to a certain concentration of grass pollen allergen solution (from positive (stage II or higher) to negative as defined in protocol section VIII.6.2 “Conjunctival Provocation Test”) between two conjunctival provocation tests (CPT) performed before and after the treatment (V7 versus V1/V2, baseline as defined in protocol section VI.1 “Inclusion criteria”). ;Timepoint(s) of evaluation of this end point: V1/2 and V7;Main Objective: The primary objective of this clinical trial is to assess the therapeutic effect (refered as E) of 3 gpASIT+TM regimens administered by subcutaneous injections in patients suffering from hay fever. The effect is to be assessed by means of the reactivity to a conjunctival provocation test (CPT) for actively treated patients in comparison to placebo regimen.;Secondary Objective: The secondary objectives 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Reactivity to CPT ? The proportion of patients in each of the four treatments groups with a reduction of reactivity to conjunctival provocation tests between V6 and V1/V2 (baseline as defined in protocol section VI.1 “Inclusion criteria”). ? The proportion of patients in each of the four treatments groups who received 170 µg (patients from treatment group III and IV together) with a reduction of reactivity to conjunctival provocation test between V6 and V1/V2 (baseline as defined in protocol section VI.1 “Inclusion criteria”) ? The mean change in allergic severity C (defined in protocol section XVI. “Statistical Methods and Considerations”) from baseline (V1/V2) and V6 and from baseline (V1/V2) to V7 (baseline as defined in section VI.1 “Inclusion criteria” of the protocol) • The immunological status of the patients will be assessed as follows ? The evolution of grass pollen specific IgE, IgG4 and IgG serum levels ? The evolution of blocking antibodies serum levels • The safety and clinical tolerability of gpASIT+TM will be assessed as follows ? The occurrence of local reactions at the injection site (wheal and redness) after investigational product administration ? The occurrence of allergic systemic reactions after investigational product administration ? The description of the (serious) adverse events (frequency, intensity/severity and duration of adverse events) during the cluster titration ? The physical examinations, vital signs ? The laboratory investigation (hematology, clinical biochemistry, immunological parameters);Timepoint(s) of evaluation of this end point: The proportion of patients in each of the groups with a reduction of reactivity to CPT between V6 and V1/V2 The proportion of patients in each of the groups who received 170 µg with a reduction of reactivity to CPT between V6 and V1/V2 The mean change in allergic severity C from V1/V2 and V6 and from V1/V2 to V7 The evolution of grass pollen specific IgE, IgG4 and IgG se | — |
Countries
Germany
Contacts
Public ContactContract Research Organisation
Institut für Medizinische Statistik, Informatik und Epidemiologie
Outcome results
None listed