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

NCT ID: NCT03724240

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 624 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2019-12-31

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

Conditions

Hay Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo solution

Placebo Comparator: Placebo The product will be supplied as ready-to-use vials containing 1.5 mL of aqueous buffered solutions at pH 7.4 containing sodium phosphate, NaCl, mannitol and trehalose. the dosage is100 µg/ml. The treatment schedule will consist in a subcutaneous injection over four visits during 3 consecutive weeks. The patient will receive two injections (1 per arm)with an interval of 30 minutes between both.

Group Type: PLACEBO_COMPARATOR

Placebo solution

Intervention Type: BIOLOGICAL

4 x 2 injection over 21 days the dosage is100 µg/ml

gpASIT+™ (Grass Pollen-ASIT+™)

Experimental: gpASIT+™ The product will be supplied as ready-to-use vials containing 1.5 mL of aqueous buffered solutions at pH 7.4 with a grass pollen peptide concentration of 100 µg/mL. Excipients are sodium phosphate, NaCl, mannitol and trehalose. the dosage is100 µg/ml.The treatment schedule will consist in a subcutaneous injection over four visits during 3 consecutive weeks.The patient will receive two injections (1 per arm)with an interval of 30 minutes between both.

Group Type: EXPERIMENTAL

gpASIT+TM

Intervention Type: BIOLOGICAL

4 x 2 injection over 21 days the dosage is100 µg/ml

Interventions

Placebo solution

4 x 2 injection over 21 days the dosage is100 µg/ml

Intervention Type: BIOLOGICAL

gpASIT+TM

4 x 2 injection over 21 days the dosage is100 µg/ml

Intervention Type: BIOLOGICAL

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ASIT Biotech S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bachert Claus, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Uz Gent-Gent, Belgium

Central Contacts

Remy Von Frenckell, clinDev

Role: CONTACT

remy.vonfrenckell@biotech.be

0032 2 264 03 90

Florence Lair, CPM

Role: CONTACT

florence.lair@biotech.be

0032 2 264 0390

Other Identifiers

2017-002911-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ABT-gpASIT011

Identifier Type: -

Identifier Source: org_study_id