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

Primary Purpose

Hay Fever

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo solution

gpASIT+TM

About this trial

This is an interventional treatment trial for Hay Fever

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Ghent
Clinica dell'Azienda Opsedaliera Luigi Sacco
Fundacion Jiménez Diaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

gpASIT+TM

Arm Description

Outcomes

Primary Outcome Measures

Combined Symptom and Medication Score (CSMS)

Secondary Outcome Measures

Combined Symptom and Medication Score (CSMS)

Symptom sub-scores (Eyes, Nose)

Well days: number of days with symptomatic score below or equal to 2 and no rescue medication

Lung Symptom Score (LLS: the average of coughing, wheezing, chest tightness and exercise induced dyspnoea scores) in asthmatic patients

Total Symptom Score (TSS: the sum of the nose, eye and lung scores) in asthmatic patients

Use of rescue medication to relief asthma symptoms in asthmatic patients

Conjunctival Provocation Test (CPT) outcomes

Standardized Quality-of-Life Questionnaires for asthma and rhinoconjunctivitis

Number of working day lost due to grass pollen induced-allergy symptoms

Loss of productivity at work due to grass pollen induced-allergy symptoms, using a visual analog scale (VAS)

Solicited adverse events

Local reactions at the injection site (swelling and redness) Allergic systemic reactions

Unsolicited adverse events and serious adverse events

Physical examinations and vital signs

Laboratory investigations (haematology, clinical biochemistry, immunological parameters)

Use of rescue medication

Full Information

NCT ID

NCT02560948

First Posted

September 23, 2015

Last Updated

October 10, 2018

Sponsor

BioTech Tools S.A.

1. Study Identification

Unique Protocol Identification Number

NCT02560948

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioTech Tools S.A.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hay Fever

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

554 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

gpASIT+TM

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Placebo solution

Intervention Description

4 x 2 injections over 21 days

Intervention Type

Biological

Intervention Name(s)

gpASIT+TM

Intervention Description

4 x 2 injections over 21 days

Primary Outcome Measure Information:

Title

Combined Symptom and Medication Score (CSMS)

Time Frame

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 Measure Information:

Title

Combined Symptom and Medication Score (CSMS)

Time Frame

over the entire grass pollen season estimated between 3 and 6 months after treatment

Title

Symptom sub-scores (Eyes, Nose)

Time Frame

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

Title

Well days: number of days with symptomatic score below or equal to 2 and no rescue medication

Time Frame

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

Title

Lung Symptom Score (LLS: the average of coughing, wheezing, chest tightness and exercise induced dyspnoea scores) in asthmatic patients

Time Frame

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

Title

Total Symptom Score (TSS: the sum of the nose, eye and lung scores) in asthmatic patients

Time Frame

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

Title

Use of rescue medication to relief asthma symptoms in asthmatic patients

Time Frame

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

Title

Conjunctival Provocation Test (CPT) outcomes

Time Frame

at baseline and up to 6 weeks

Title

Standardized Quality-of-Life Questionnaires for asthma and rhinoconjunctivitis

Time Frame

between 2 weeks and 8 months after treatment

Title

Number of working day lost due to grass pollen induced-allergy symptoms

Time Frame

between 2 weeks and 8 months after treatment

Title

Loss of productivity at work due to grass pollen induced-allergy symptoms, using a visual analog scale (VAS)

Time Frame

between 2 weeks and 8 months after treatment

Title

Solicited adverse events

Description

Local reactions at the injection site (swelling and redness) Allergic systemic reactions

Time Frame

up to 4 weeks

Title

Unsolicited adverse events and serious adverse events

Time Frame

up to 8 months

Title

Physical examinations and vital signs

Time Frame

up to 8 months

Title

Laboratory investigations (haematology, clinical biochemistry, immunological parameters)

Time Frame

up to 8 months

Title

Use of rescue medication

Time Frame

up to 4 weeks

Other Pre-specified Outcome Measures:

Title

Production of grass pollen specific immunoglobulins IgE, IgG and IgG4

Time Frame

up to 8 months

Title

Production of blocking antibodies (FAB assay)

Time Frame

up to 8 months

Title

Reduction of Th2 response by measuring IL-4+ and IFN-gamma+ production

Time Frame

up to 8 months

Title

Induction of regulatory T cells (Treg)

Time Frame

up to 8 months

Title

Induction of regulatory B cells (Breg) and their phenotyping

Time Frame

up to 8 months

Title

Reduction of basophil activation measured through detection of CD63 expression marker on activated cells

Time Frame

up to 8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: