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

Phase 3

Completed

• Conditions: Hay Fever
• Interventions: Biological: gpASIT+TM; Biological: Placebo solution

• Registration Number: NCT02560948
• Lead Sponsor: BioTech Tools S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Study Start: 2015-12
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gpASIT+TM	gpASIT+TM	-
Placebo	Placebo solution	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Solicited adverse events	up to 4 weeks	* Local reactions at the injection site (swelling and redness); * Allergic systemic reactions
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
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
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
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
Unsolicited adverse events and serious adverse events	up to 8 months
Use of rescue medication	up to 4 weeks
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
Conjunctival Provocation Test (CPT) outcomes	at baseline and up to 6 weeks
Number of working day lost due to grass pollen induced-allergy symptoms	between 2 weeks and 8 months after treatment
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
Physical examinations and vital signs	up to 8 months
Laboratory investigations (haematology, clinical biochemistry, immunological parameters)	up to 8 months
Combined Symptom and Medication Score (CSMS)	over the entire grass pollen season estimated between 3 and 6 months after treatment
Standardized Quality-of-Life Questionnaires for asthma and rhinoconjunctivitis	between 2 weeks and 8 months after treatment

Trial Locations

Locations (3)

Clinica dell'Azienda Opsedaliera Luigi Sacco; 🇮🇹 Milano, Italy

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Fundacion Jiménez Diaz; 🇪🇸 Madrid, Spain