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

October 10, 2018 updated by: BioTech Tools S.A.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
554

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • University Hospital Ghent
  • Italy
      • Milano, Italy
        • Clinica dell'Azienda Opsedaliera Luigi Sacco
  • Spain
      • Madrid, Spain
        • Fundación Jiménez Díaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Biological: Placebo solution
4 x 2 injections over 21 days
Experimental: gpASIT+TM
Biological: gpASIT+TM
4 x 2 injections over 21 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Combined Symptom and Medication Score (CSMS)
Time Frame: over the entire grass pollen season estimated between 3 and 6 months after treatment
over the entire grass pollen season estimated between 3 and 6 months after treatment
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
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
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
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
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
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
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
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
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
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
Time Frame: at baseline and up to 6 weeks
at baseline and up to 6 weeks
Standardized Quality-of-Life Questionnaires for asthma and rhinoconjunctivitis
Time Frame: between 2 weeks and 8 months after treatment
between 2 weeks and 8 months after treatment
Number of working day lost due to grass pollen induced-allergy symptoms
Time Frame: between 2 weeks and 8 months after treatment
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)
Time Frame: between 2 weeks and 8 months after treatment
between 2 weeks and 8 months after treatment
Solicited adverse events
Time Frame: up to 4 weeks
  • Local reactions at the injection site (swelling and redness)
  • Allergic systemic reactions
up to 4 weeks
Unsolicited adverse events and serious adverse events
Time Frame: up to 8 months
up to 8 months
Physical examinations and vital signs
Time Frame: up to 8 months
up to 8 months
Laboratory investigations (haematology, clinical biochemistry, immunological parameters)
Time Frame: up to 8 months
up to 8 months
Use of rescue medication
Time Frame: up to 4 weeks
up to 4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Production of grass pollen specific immunoglobulins IgE, IgG and IgG4
Time Frame: up to 8 months
up to 8 months
Production of blocking antibodies (FAB assay)
Time Frame: up to 8 months
up to 8 months
Reduction of Th2 response by measuring IL-4+ and IFN-gamma+ production
Time Frame: up to 8 months
up to 8 months
Induction of regulatory T cells (Treg)
Time Frame: up to 8 months
up to 8 months
Induction of regulatory B cells (Breg) and their phenotyping
Time Frame: up to 8 months
up to 8 months
Reduction of basophil activation measured through detection of CD63 expression marker on activated cells
Time Frame: up to 8 months
up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioTech Tools S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ralph Mösges, Professor, Private practice, Aachen, Germany
  • Principal Investigator: Claus Bachert, Professor, UZ Gent, Gent, Belgium
  • Principal Investigator: Petr Panzner, MD, University Hospital of Pilsen, Pilsen, Czech Republic
  • Principal Investigator: Frédéric de Blay, Professor, CHRU de Strasbourg, Strasbourg, France
  • Principal Investigator: Enrico Iemoli, MD, Clinica dell'Azienda Ospedaliera Luigi Sacco Di Milano, Milano, Italy
  • Principal Investigator: Joachin Sastre, Professor, Fundación Jiménez Díaz, Madrid,Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTT-gpASIT009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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