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

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Status and phase

Completed

Phase 3

Conditions

Hay Fever

Treatments

Biological: Placebo solution

Biological: gpASIT+TM

Study type

Interventional

Funder types

Industry

Identifiers

NCT02560948

BTT-gpASIT009

Details and patient eligibility

About

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.

Enrollment

554 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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