A Multicentre, International, Randomised, Double-blind, Placebo-controlled Study to Demonstrate the Clinical Efficacy and Safety of Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hay Fever
- Sponsor
- ASIT Biotech S.A.
- Enrollment
- 624
- Primary Endpoint
- Average daily Combined Symptom and Medication Score collected during the peak of the grass pollen season
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a randomised, double-blind, placebo-controlled, international, multicentre, confirmatory Phase III study in patients with grass pollen-related allergic rhinoconjunctivitis. After having given written informed consent, the patients will be examined to establish eligibility according to inclusion/exclusion criteria. The eligible patients will be randomised to Placebo or gpASIT+™ treatment according to a 1:1 ratio. Study treatment will be administered before the start of the pollen season in 2019
Investigators
Eligibility Criteria
Inclusion Criteria
- •Allergy diagnosis:
- •A clinical history of moderate to severe grass pollen-induced Seasonal Allergic Rhinoconjunctivitis (SARC) for at least 2 pollen seasons, requiring treatment with either antihistamines or nasal corticosteroids during the 2017 and 2018 grass pollen seasons and with symptoms interfering with usual daily activities or with sleep, as defined according to Allergic Rhinitis and its Impact on Asthma (ARIA) classification of rhinitis (Bousquet et al. 2001)
- •A positive Skin Prick Test (SPT) (wheal diameter ≥3 mm) to grass pollen mixture, histamine wheal ≥3 mm, sodium chloride (NaCl) control reaction \<2 mm AND
- •Specific IgE against grass pollen ≥0.7 kU/L. 6)
- •For asthmatic patients, confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA; 2018)
Exclusion Criteria
- •Diagnosis of mastocytosis;
- •Previous (within the last 5 years) immunotherapy with grass allergens;
- •Ongoing immunotherapy with grass allergens or any other allergens;
- •Patients with any history of anaphylaxis due to any cause;
- •Patients with a history of hypersensitivity to the excipients of the investigational product;
- •Patients with a forced expiratory volume in 1 second (FEV1) \<80% of the predicted value (European Community for Steel and Coal) or with a peak expiratory flow (PEF) \<70% of the individual optimum value at the Screening visit;
- •History of being intubated with mechanical ventilator support or in intensive care unit for asthma at any point in the patient's life;
- •History of emergency visit or hospital admission for asthma in the previous 12 months;
- •Clinical history of moderate to severe allergic rhinitis, as defined according to the ARIA classification of rhinitis, due to tree pollen near or overlapping the grass pollen season;
- •Clinical history of moderate to severe allergic rhinitis as defined according to the ARIA classification of rhinitis caused by an allergen to which the participant is regularly exposed;
Outcomes
Primary Outcomes
Average daily Combined Symptom and Medication Score collected during the peak of the grass pollen season
Time Frame: the patients assessed up to 9 months. [Safety Issue: No]
Symptoms are measured on a scale from 0 to 3- No symptoms= 0 mild symptoms=1 moderate symptoms =2 severe symptoms =3. Daily symptom score is calculated as: daily RTSS/6. Medication score: No rescue medications used =0 Tablet of antihistamine = 1 Nasal spray of fluticasone propionate with or without antihistamine= 2 Tablet of methylprednisolone with or without antihistamine/ fluticasone propionate= 3 Maximum daily Rescue Medication Score (RMS):3 CSMS= dSS (daily symptom score) (0-3) + dMS (daily medication score)(0-3)= 0-6 The daily symptom score and the daily RMS each range from 0 to 3 and, thus, the daily CSMS ranges from 0 to 6. The average CSMS of the peak of the grass pollen season or the whole grass pollen season will be calculated, per patient, as the sum of the daily CSMS within the peak of pollen season or the whole pollen season divided by the number of days of the peak pollen season or the whole pollen season, respectively (as defined by Pfaar et al. 2014).
Secondary Outcomes
- Combined symptom and medication score (CSMS) over the entire grass pollen season(the patients assessed up to 9 months. [Safety Issue: No])
- Symptom subscores (eyes and nose) over the peak period and the entire grass pollen season(the patients assessed up to 9 months. [Safety Issue: No])
- Number (%) of "well days"(the patients assessed up to 9 months. [Safety Issue: No])
- Number of working days lost due to grass pollen-induced allergy symptoms(the patients assessed up to 9 months. [Safety Issue: No])
- Patient's Global Efficacy (PGE) assessment.(the patients assessed up to 9 months. [Safety Issue: No])
- Total Symptom Score (TSS: the sum of the eyes, nose and lung symptom scores) in asthmatic patients only over the peak period and the entire grass pollen season(the patients assessed up to 9 months. [Safety Issue: No])
- Use of rescue medication to relieve asthma symptoms in asthmatic patients(the patients assessed up to 9 months. [Safety Issue: No])
- Local reactions at the injection site (swelling and redness) after investigational product administration(up to 4 weeks [Safety Issue: Yes])
- Induction of grass pollen-specific Immunoglobulin: IgE, IgG and IgG4 in serum of all patients(up to 8 months [Safety Issue: No])
- Standardised Rhinoconjunctivitis Quality of Life Questionnaire in all patients(the patients assessed up to 9 months. [Safety Issue: No])
- Systemic allergic reactions <30 minutes after investigational product administration(up to 4 months ( safety issue:No))
- Other treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)(up to 8 months [Safety Issue: Yes])