Treatment of seasonal grass pollen rhinoconjunctivitis MedDRA version: 18.0 Level: LLT Classification code 10019170 Term: Hay fever System Organ Class: 100000004870
Conditions
Interventions
Product Name: gpASIT+TM
Pharmaceutical Form: Injection
INN or Proposed INN: gpASIT+TM
Other descriptive name: POLLEN PEPTIDES
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equa
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 18–64 years • The patients are in good physical and mental health according to his/her medical history and vital signs • For Females: non-pregnant, non-lactating females with adequate contraception or females unable to bear children (i.e. tubul 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 (SARC) for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al 2001)) o A positive skin prick test (SPT - wheal diameter = 3 mm) to grass pollen mixture, histamine wheal = 3 mm, NaCl control reaction 0.7 kU/L. o Positive response to CPT with at least 10,000 SQ-E/mL of grass allergens • Patients treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrollment • For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014) • For patients with co-sensitisation to birch and parietaria pollen allergens, all of the following criteria must be fulfilled: o The result of the SPT to birch and parietaria pollen has to be less than the result to grass pollen o The specific-IgE level to birch and parietaria pollen allergens has to be less than the specific-IgE level to grass (the CAP RAST class for birch and parietaria has to be at least 1 CAP RAST class less than the CAP RAST class for grass) 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 654 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 with grass allergens or any other allergens • 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 anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin) • Patients with a history of hypersensitivity to the excipients of the investigational product (gpASIT+TM or placebo) • Patients with partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014). • Patients with chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the predicted value (ECSC) or with a peak expiratory flow (PEF) < 70% of the individual optimum value • Patients symptomatic to inhaled allergens circulating during the grass pollen season (specific to each country: e.g. birch, hazel, mugwort, ragweed, olive, Alternaria alternata) • Patients symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed • Patients with a history of significant renal disease or chronic hepatic disease • Patients with malignant disease • Patients with a known severe autoimmune disease • Patients with any chronic disease which may impair the patient’s ability to participate in the trial (e.g. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.) • Patients requiring beta-blockers/acetylcholinesterase inhibitors medication • Patients requiring antidepressant drugs with potent antihistamine properties i.e. tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.) • Patients requiring anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents • Patients with any contraindication for the use of adrenaline • Patients with a known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus • Patients who are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before study entry • Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method • Consumption of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in Chapter VIII.6 of the protocol • Patients with laboratory values greater than grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit * • 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 *Patients with laboratory values greater than grade 1 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit will require a retest and only if normalising, the patient will be eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are • To assess individual symptom and medication scores over the peak and entire pollen season after treatment with gpASIT+TM compared to placebo, • To assess changes in allergic reactivity to Conjunctival Provocation Test (CPT) after treatment with gpASIT+TM compared to placebo, • To assess the Quality-of-Life of patients and health economic aspects after treatment with gpASIT+TM compared to placebo, • To assess the safety and clinical tolerability of gpASIT+TM treatment. ;Primary end point(s): The primary endpoint will be the reduction - in the treated group compared to the placebo group - of the Combined Symptom and Medication Score (CSMS) taking into account the daily Rhinoconjunctivitis Total Symptom Score (RTSS) and the daily Rescue Medication Score (RMS) over the peak of grass pollen season subsequent to treatment. ;Timepoint(s) of evaluation of this end point: Reduction of the Combined Symptom and Medication Score (CSMS): over the peak of the grass pollen season.;Main Objective: The primary objective of this clinical trial is to demonstrate the clinical efficacy of gpASIT+TM during the peak of the grass pollen season following subcutaneous administration to patients suffering from hay fever. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Clinical efficacy endpoints will include: - Combined Symptom and Medication Score (CSMS) over the entire grass pollen season - Rhinoconjunctivitis Total Symptom Score (RTSS) over the peak period and the pollen season - Rescue Medication Score (RMS) over the peak period and the pollen season - Symptom sub-scores (Eyes, Nose) over the peak period and the pollen season - Well days over the peak period and the pollen season - In asthmatic patients - Lung symptoms over the peak period and the pollen season - Total Symptom Score (TSS; the sum of the nose, eye and lung scores) over the peak period and the pollen season - Use of rescue medication to relief asthma symptoms over the peak period and the pollen season • Conjunctival Provocation Test (CPT) outcomes • Quality-of-Life Questionnaires: - Standardised Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ(S)) and Nocturnal Rhinoconjunctivitis Quality-of-Life Questionnaire (NRQLQ) in all patients - Standardised Asthma Quality-of-Life Questionnaire (AQLQ(S)) in asthmatic patients • Health economic endpoints: - Number of working days lost due to grass pollen-induced allergy symptoms - Loss of productivity at work due to grass pollen induced-allergy symptoms, using a visual analog scale (VAS) • Responder analysis on - Reactivity to CPT: one patient will be considered as a responder if the reactivity to CPT decreases between V1 and V6 - CSMS over the peak pollen period and entire pollen season: one patient will be considered as a responder if the score is lower of at least 20% with respect to the median score observed in the placebo group • Safety and clinical tolerability endpoints will include: - Solicited adverse events: - Local reactions at the injection site (swelling and redness) after investigational product administration ? - Allergic systemic reactions after investigational product ad | — |
Countries
Belgium, Czech Republic, France, Germany, Spain
Contacts
Public ContactPirotton Sabine
BioTech Tools S.A.
Outcome results
None listed