Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis

Study Overview
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Brief Summary
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gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this study is to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis compared to placebo.

Official Title
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A Multicenter, International, Randomised, Double-blind, Placebo Controlled Study to Demonstrate the Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis

Conditions
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Hay Fever

Intervention / Treatment
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* Biological: Placebo solution
* Biological: gpASIT+TM


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Allergy diagnosis: 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)) A positive skin prick test (SPT - wheal diameter ≥ 3 mm) to grass pollen mixture, histamine wheal ≥ 3 mm, NaCl control reaction < 2 mm Specific IgE against grass pollen (with recombinant allergens - g213) > 0.7 kU/L 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) Key Exclusion Criteria: Previous immunotherapy with grass allergens within the last 5 years Ongoing immunotherapy with grass allergens or any other allergens 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Biological: Placebo solution<br>* 4 x 2 injections over 21 days<br>|
| Experimental: gpASIT+TM<br> | Biological: gpASIT+TM<br>* 4 x 2 injections over 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Symptom and Medication Score (CSMS) |  | over the peak (corresponding to 14 consecutive days with highest pollen counts) of grass pollen season estimated between 3 and 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Symptom and Medication Score (CSMS) |  | over the entire grass pollen season estimated between 3 and 6 months after treatment | 
| Symptom sub-scores (Eyes, Nose) |  | over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment | 
| Well days: number of days with symptomatic score below or equal to 2 and no rescue medication |  | over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment | 
| Lung Symptom Score (LLS: the average of coughing, wheezing, chest tightness and exercise induced dyspnoea scores) in asthmatic patients |  | over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment | 
| Total Symptom Score (TSS: the sum of the nose, eye and lung scores) in asthmatic patients |  | over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and the pollen season estimated between 3 and 6 months after treatment | 
| Use of rescue medication to relief asthma symptoms in asthmatic patients |  | over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and the pollen season estimated between 3 and 6 months after treatment | 
| Conjunctival Provocation Test (CPT) outcomes |  | at baseline and up to 6 weeks | 
| Standardized Quality-of-Life Questionnaires for asthma and rhinoconjunctivitis |  | between 2 weeks and 8 months after treatment | 
| Number of working day lost due to grass pollen induced-allergy symptoms |  | between 2 weeks and 8 months after treatment | 
| Loss of productivity at work due to grass pollen induced-allergy symptoms, using a visual analog scale (VAS) |  | between 2 weeks and 8 months after treatment | 
| Solicited adverse events | Local reactions at the injection site (swelling and redness) Allergic systemic reactions | up to 4 weeks | 
| Unsolicited adverse events and serious adverse events |  | up to 8 months | 
| Physical examinations and vital signs |  | up to 8 months | 
| Laboratory investigations (haematology, clinical biochemistry, immunological parameters) |  | up to 8 months | 
| Use of rescue medication |  | up to 4 weeks |