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

NCT03724240 | Unknown Phase 3 DMC

• 2 other identifiers: ABT-gpASIT0112017-002911-33
• Study Type: interventional
• Target: 624
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Average daily Combined Symptom and Medication Score collected during the peak of the grass pollen season

  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).

  the patients assessed up to 9 months. [Safety Issue: No]

Secondary Outcomes (12)

• 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]

• 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]

• Number (%) of "well days"

  the patients assessed up to 9 months. [Safety Issue: No]

Study Arms (2)

Placebo solution

PLACEBO COMPARATOR

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.

Biological: Placebo solution

gpASIT+™ (Grass Pollen-ASIT+™)

EXPERIMENTAL

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.

Biological: gpASIT+TM

Interventions

Placebo solution BIOLOGICAL

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

Placebo solution

gpASIT+TM BIOLOGICAL

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

gpASIT+™ (Grass Pollen-ASIT+™)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• ASIT Biotech S.A.: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Bachert Claus, Prof Dr

  Uz Gent-Gent, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Remy Von Frenckell, clinDev

CONTACT

0032 2 264 03 90; remy.vonfrenckell@biotech.be

Florence Lair, CPM

CONTACT

0032 2 264 0390; florence.lair@biotech.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 30, 2018
• Study Start: January 2, 2019
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 30, 2018

Record last verified: 2018-10