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

Hay Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560948
• Other study ID #: BTT-gpASIT009
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2015
• Source: BioTech Tools S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Conjunctivitis, Allergic
• Hay Fever
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• Placebo solution
4 x 2 injections over 21 days
• gpASIT+TM
4 x 2 injections over 21 days

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent
Italy	Clinica dell'Azienda Opsedaliera Luigi Sacco	Milano
Spain	Fundacion Jiménez Diaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
BioTech Tools S.A.

Countries where clinical trial is conducted

Belgium,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Production of grass pollen specific immunoglobulins IgE, IgG and IgG4		up to 8 months
Other	Production of blocking antibodies (FAB assay)		up to 8 months
Other	Reduction of Th2 response by measuring IL-4+ and IFN-gamma+ production		up to 8 months
Other	Induction of regulatory T cells (Treg)		up to 8 months
Other	Induction of regulatory B cells (Breg) and their phenotyping		up to 8 months
Other	Reduction of basophil activation measured through detection of CD63 expression marker on activated cells		up to 8 months
Primary	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	Combined Symptom and Medication Score (CSMS)		over the entire grass pollen season estimated between 3 and 6 months after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Conjunctival Provocation Test (CPT) outcomes		at baseline and up to 6 weeks
Secondary	Standardized Quality-of-Life Questionnaires for asthma and rhinoconjunctivitis		between 2 weeks and 8 months after treatment
Secondary	Number of working day lost due to grass pollen induced-allergy symptoms		between 2 weeks and 8 months after treatment
Secondary	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
Secondary	Solicited adverse events	Local reactions at the injection site (swelling and redness); Allergic systemic reactions	up to 4 weeks
Secondary	Unsolicited adverse events and serious adverse events		up to 8 months
Secondary	Physical examinations and vital signs		up to 8 months
Secondary	Laboratory investigations (haematology, clinical biochemistry, immunological parameters)		up to 8 months
Secondary	Use of rescue medication		up to 4 weeks