Hay FeverPhase 3NCT03724240
Clinical Efficacy and Safety of Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis
A Phase 3 study testing gpASIT+TM in people with Hay Fever, run by ASIT Biotech S.A..
Trial summary
This is a randomised, double-blind, placebo-controlled, international, multicentre, confirmatory Phase III study in patients with grass pollen-related allergic rhinoconjunctivitis. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hay Fever
- What is being tested?
- gpASIT+TM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 624 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2019to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicentre, International, Randomised, Double-blind, Placebo-controlled Study to Demonstrate the Clinical Efficacy and Safety of Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis
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
- Being tested
- Placebo solution, gpASIT+TM
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo solutionBiological
4 x 2 injection over 21 days the dosage is100 µg/ml
gpASIT+TMBiological
4 x 2 injection over 21 days the dosage is100 µg/ml
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: gpASIT+TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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
Symptom scores for nose (rhinorrhoea, sneezing, nasal pruritus, nasal congestion) and eye (ocular pruritus, watery eyes) symptoms will be collected on a daily basis, using a four-point ordinal scale.
Nasal symptoms:
(Score 0-3) 0 = no symptoms
- = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated)
- = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable)
- = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) Itchy nose:0-3 Sneezing:0-3 Runny nose:0-3 Blocked nose:0-3
Conjunctival symptoms:
Itchy/red eyes:0-3 Watery eyes:0-3
Measured: 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 daily Rhinoconjunctivitis Total Symptom Score (RTSS) will correspond to the sum of the six nose and eye symptoms (score ranging from 0 to 18). Then, daily symptom score is calculated as: daily RTSS/6.The common rating system is the following:
- 0 = no symptoms;
- 1 = mild symptoms (sign/symptom clearly present but minimal awareness, easily tolerated);
- 2 = moderate symptoms (definite awareness of any sign/symptom that is bothersome but tolerated);
- 3 = severe symptoms (sign/symptom that is hard to tolerate, causing interference with activities of daily living and/or sleeping) as defined by Pfaar et al. 2014
Measured: the patients assessed up to 9 months. [Safety Issue: No]
Use of rescue medication to relieve asthma symptoms in asthmatic patients
Patients will be instructed to use the rescue medications according to the following standardised and stepwise procedure: 1. In first instance: oral H1 antihistamine (desloratadine, one 5 mg tablet/day); 2. If Step 1 fails or is insufficient, intranasal corticosteroid: fluticasone propionate (50 µg/dose, one puff/nostril as needed) (alone or combined with oral antihistamine); 3. If Step 2 fails: oral corticosteroid (methylprednisolone 16 mg tablet, one tablet/day for a maximum of 3 days).
Measured: the patients assessed up to 9 months. [Safety Issue: No]
Number (%) of "well days"
A "well day" is a day for which the patient does not report any intake of any rescue medication ( RMS = 0) and with no Grade ≥2 individual eye or nose symptom and overall Rhinoconjunctivitis Total Symptom Score (RTSS) ≤2.
Measured: the patients assessed up to 9 months. [Safety Issue: No]
Standardised Rhinoconjunctivitis Quality of Life Questionnaire in all patients
to measure the functional impairments of the patients resulting from their rhinoconjunctivitis in their day-to-day life (Juniper et al. 1999)-The validated RQLQ has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). There are 3 'patient-specific' questions in the activity domain which allow patients to select 3 activities in which they are most limited by their rhinoconjunctivitis. Patients recall how bothered they have been by their rhinoconjunctivitis during the previous week and to respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains.
Measured: the patients assessed up to 9 months. [Safety Issue: No]
Patient's Global Efficacy (PGE) assessment.
At the end of the study, the patients will be asked how they have felt overall during the study grass pollen season compared to previous grass pollen seasons ("much better", "better", "the same", "worse", "much worse"
Measured: the patients assessed up to 9 months. [Safety Issue: No]
Number of working days lost due to grass pollen-induced allergy symptoms
Absenteeism, evaluated by recording the number of working days lost due to grass pollen-induced allergic rhinoconjunctivitis
Measured: the patients assessed up to 9 months. [Safety Issue: No]
Systemic allergic reactions <30 minutes after investigational product administration
Immediate and delayed systemic reactions will be graded according to the World Allergy Organisation classification (Cox et al. 2010).
Measured: up to 4 months ( safety issue:No)
Local reactions at the injection site (swelling and redness) after investigational product administration
local reaction (wheal diameter) is 5 to 8 cm
Measured: up to 4 weeks [Safety Issue: Yes]
Other treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
A TEAE is defined as an event that emerges during treatment having been absent pre-treatment, or which worsens relative to the pre-treatment state.Adverse Events will be tabulated by System Organ Class (SOC) and Preferred Term (PT) after medical coding using MedDRA
Measured: up to 8 months [Safety Issue: Yes]
Induction of grass pollen-specific Immunoglobulin: IgE, IgG and IgG4 in serum of all patients
In all patients at all sites, 2 mL of blood will be withdrawn for the measurement of grass pollen-specific IgE, IgG4 and IgG in serum sites. Grass pollen-specific IgE, IgG and IgG4 measurements in patient serum will be assessed by ImmunoCAP® method in a central laboratory
Measured: up to 8 months [Safety Issue: No]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start2 Jan 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hay FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASIT Biotech S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bachert Claus, Prof Dr, Principal investigator, Uz Gent-Gent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724240
- Sponsor's protocol ID
- ABT-gpASIT011
- Other IDs
- 2017-002911-33, 2017
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, International, Randomised, Double-blind, Placebo-controlled Study to Demonstrate the Clinical Efficacy and Safety of Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT03724240
- Acronym / sponsor ID
- ABT-gpASIT011
- Conditions
- Hay Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- ASIT Biotech S.A.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo solution | Placebo comparator | Biological: Placebo solutionPlacebo 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. |
| gpASIT+™ (Grass Pollen-ASIT+™) | Experimental | Biological: gpASIT+TMExperimental: 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo solution4 x 2 injection over 21 days the dosage is100 µg/ml | Biological | Placebo solution |
| gpASIT+TM4 x 2 injection over 21 days the dosage is100 µg/ml | Biological | gpASIT+™ (Grass Pollen-ASIT+™) |
Primary outcome
Average daily Combined Symptom and Medication Score collected during the peak of the grass pollen season
Time frame: the patients assessed up to 9 months. [Safety Issue: No]
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).
12 secondary outcomes
Combined symptom and medication score (CSMS) over the entire grass pollen season
Time frame: 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
Time frame: 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
Time frame: the patients assessed up to 9 months. [Safety Issue: No]
Use of rescue medication to relieve asthma symptoms in asthmatic patients
Time frame: the patients assessed up to 9 months. [Safety Issue: No]
Number (%) of "well days"
Time frame: the patients assessed up to 9 months. [Safety Issue: No]
Standardised Rhinoconjunctivitis Quality of Life Questionnaire in all patients
Time frame: the patients assessed up to 9 months. [Safety Issue: No]
Patient's Global Efficacy (PGE) assessment.
Time frame: the patients assessed up to 9 months. [Safety Issue: No]
Number of working days lost due to grass pollen-induced allergy symptoms
Time frame: the patients assessed up to 9 months. [Safety Issue: No]
Systemic allergic reactions <30 minutes after investigational product administration
Time frame: up to 4 months ( safety issue:No)
Local reactions at the injection site (swelling and redness) after investigational product administration
Time frame: up to 4 weeks [Safety Issue: Yes]
Other treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: up to 8 months [Safety Issue: Yes]
Induction of grass pollen-specific Immunoglobulin: IgE, IgG and IgG4 in serum of all patients
Time frame: up to 8 months [Safety Issue: No]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bachert Claus, Prof Dr principal investigator
Uz Gent-Gent, Belgium
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gpASIT+TM in people with Hay Fever, run by ASIT Biotech S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Remy Von Frenckell, clinDev (0032 2 264 03 90, remy.vonfrenckell@biotech.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily Combined Symptom and Medication Score collected during the peak of the grass pollen season (time frame: the patients assessed up to 9 months. [Safety Issue: No]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.