Allergic RhinitisPhase 2NCT02556801
Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy
A Phase 2 study testing SUBLIVAC FIX Phleum Prat. in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 1 site in Canada.
Trial summary
The purpose of this study is to assess safety, tolerability and demonstrate a dose response signal using Total Symptom Score (TSS), based on challenges with grass pollen in an Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of SUBLIVAC FIX Phleum (SP) after 10 months of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- SUBLIVAC FIX Phleum Prat.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who signed informed consent.
- Subjects aged ≥18 and ≤65 years at signing of informed consent.
- Subjects with at least two-year clinical history of allergic rhinitis/rhinoconjunctivitis to grass pollen, with or without concomitant asthma (asthma must be controlled).
- Subjects with a forced expiratory volume at one second (FEV1) >70% of the predicted value as measured during screening or documented within 1 year of study start.
- Subjects with a positive skin prick test (SPT) (mean wheal diameter of at least 3 mm larger than the negative control; negative control should be <2 mm, histamine control should be positive (mean wheal diameter of at least 3 mm larger than the negative control)) for grass pollen assessed during screening or a documented positive response obtained within 1 year before screening.
- Subjects with a grass pollen specific IgE greater than or equal to 0.7 kiloUnits (kU)/L assessed during screening or a documented positive result obtained within 1 year before screening.
- Subjects with a TSS of at least 10/24 during baseline EEC challenge (V2) in combination with a staff assessed score of at least 2/3 for two objective TSS symptoms (i.e. running nose, sneezing or red eyes), during the baseline EEC challenge.
Who cannot join
- Subjects with (expected) clinically relevant symptoms at the timing of the scheduled EEC assessments at Visit 2 and Visit 6 due to concomitant sensitization i.e. positive SPT (mean wheal diameter of at least 3 mm larger than the negative control) and a history of allergic response to the causative allergen, at the discretion of the investigator.
- Patients with grass pollen induced asthma.
- Subjects who cannot tolerate the Baseline Challenge in the EEC.
- Subjects who received immunotherapy (SCIT or SLIT) with grass pollen allergens within the past 5 years.
- (Ongoing) allergen-specific immunotherapy with any allergen(s) during the study period.
- Subjects with unsuccessful allergen-specific immunotherapy within the past 5 years (e.g., but not limited to, prematurely stopped immunotherapy due to non-compliance, AEs or lack of therapeutic effect), at the discretion of the investigator.
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- Subjects undergoing anti-IgE therapy within the 6 months prior to inclusion and/or during the study.
- Subjects suffering from severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
- Subjects suffering from active malignancies or any malignant disease (except for localized basal cell cancers of the skin as long as they have been adequately treated and no recurrence within 3 months of screening visit) during 5 years prior to screening.
- Subjects suffering from severe uncontrolled diseases that could increase the risk for participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders at the discretion of the Investigator.
- Subjects who have active inflammation or infection of the target organs (nose, eyes or lower airways) at Visit 1.
- Subjects suffering from diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma).
- Subjects receiving vaccination within one week before start of therapy or during the up-dosing phase.
- Subjects receiving treatment with systemic steroids within 4 weeks before visit 1 and/or during the study.
- Subjects receiving treatment with systemic or local β-blockers anytime during the study.
- Subjects who participated in a clinical study within the last 3 months (e.g. new investigational drug or biological) or within the last 30 days (e.g. bio-equivalent drug), at the discretion of the Investigator.
- Female subjects of child-bearing potential who are pregnant, lactating or using inadequate contraceptive measures (adequate contraceptive measures will be: sexual abstinence; oral contraceptives, trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to investigational medicinal product (IMP) administration); double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent; intrauterine device (IUD), intrauterine system (IUS), implant, or vaginal ring (placed at least 4 weeks prior to IMP administration); or male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into trial and is the sole sexual partner for that female subject.
- Subjects that have a history of alcohol, drug or medication abuse within the past year before study start.
- Subjects with any clinically relevant abnormal laboratory parameter at screening.
- Subjects that lack cooperation or compliance, as judged by the investigator.
- Subjects suffering from severe psychiatric, psychological, or neurological disorders.
- Subjects who are employees of the sponsor or contract research organisation and/or 1st grade relatives or partners of the (principal) investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Relative Efficacy and Safety of Immunotherapy With SUBLIVAC FIX Phleum Pratense in Grass Pollen-Allergic Subjects With IgE-Mediated Seasonal ARC
The purpose of this study is to assess safety, tolerability and demonstrate a dose response signal using Total Symptom Score (TSS), based on challenges with grass pollen in an Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo.
The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.
Read the detailed description
The current dose range finding study with SP has been designed to test three different concentrations of SUBLIVAC FIX Phleum (SP) that includes 3 doses (10,000 AUN/mL; 40,000 AUN/mL; 80,000 AUN/mL) and placebo to demonstrate a dose response signal and to estimate the minimal effective dose of SP. The study will be conducted in the target population of seasonal allergic subjects in a fully validated Environmental Exposure Chamber (EEC) system. The EEC system is a facility that has temporal uniformity of airborne allergen (pollen) exposure to subjects. Use of the EEC ensures exposure to relatively consistent levels of allergen. This facility has been used in a number of immunotherapy trials and is an improved challenge model of AR compared to the previously used nasal provocation test. Treatment duration of this study is extended to 10 months.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Being tested
- SUBLIVAC FIX Phleum Prat.
- Keywords
- Sublingual immunotherapy, Dose range finding, Grass pollen, Allergic rhinitis/rhinoconjunctivitis, Immunogenicity
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUBLIVAC FIX Phleum Prat.Biological
sublingual daily administration
| Study group | Role | What they receive |
|---|---|---|
| SUBLIVAC FIX Phleum Prat. 0 AUN/ml | Placebo comparator | 42 subjects received placebo (SUBLIVAC FIX Phleum Pratense 0 AUN/ml) sublingually. Subjects will start with one drop and add one drop each consecutive day until the maintenance dose of 5 drops per day is reached. Next treatment at maintenance dose is continued during 10 months. Receives: Biological: SUBLIVAC FIX Phleum Prat. |
| SUBLIVAC FIX Phleum Prat. 10,000 AUN/ml | Experimental | 42 subjects received SUBLIVAC FIX Phleum Pratense 10,000 AUN/ml) sublingually. Subjects will start with one drop and add one drop each consecutive day until the maintenance dose of 5 drops per day is reached. Next treatment at maintenance dose is continued during 10 months. Receives: Biological: SUBLIVAC FIX Phleum Prat. |
| SUBLIVAC FIX Phleum Prat. 40,000 AUN/ml | Experimental | 40 subjects received SUBLIVAC FIX Phleum Pratense 40,000 AUN/ml sublingually. Subjects will start with one drop and add one drop each consecutive day until the maintenance dose of 5 drops per day is reached. Next treatment at maintenance dose is continued during 10 months. Receives: Biological: SUBLIVAC FIX Phleum Prat. |
| SUBLIVAC FIX Phleum Prat. 80,000 AUN/ml | Experimental | 40 subjects received SUBLIVAC FIX Phleum Pratense 80,000 AUN/ml sublingually. Subjects will start with one drop and add one drop each consecutive day until the maintenance dose of 5 drops per day is reached. Next treatment at maintenance dose is continued during 10 months. Receives: Biological: SUBLIVAC FIX Phleum Prat. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Total Symptom Score (TSS) After 10 Months of Treatment (Visit 6) Compared to Placebo
The primary endpoint was the TSS after 10 months of treatment (at visit 6). The mean TSS at visit 6 was calculated as an average of all non-missing TSS scores between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 6. TSS was computed as the sum of individual scores for eight nasal and non-nasal symptoms (rhinorrhea, congestion, sneezing, itchiness, itchy/gritty eyes, tearing/watery eyes, red/burning eyes, and ear/palate itching). Each of eight symptoms was rated on a scale of 0-3 as follows: 0, none; 1, mild; 2, moderate; 3, severe. The range of TSS is from 0 to 24 units on a scale. The highest the score, the more severe symptoms a subject experiences. Negative change of TSS between baseline and visit 6 was expected (reduced symptoms), more negative change at visit 6 versus baseline represents better outcome of the study.
Measured: 10 months after treatment start (baseline - Visit 2)
Secondary outcomes (8)
Change From Baseline in Mean Total Symptom Score (TSS) After 10 Months of Treatment (Visit 6)
The change from baseline of the mean TSS at visit 6. The baseline will be calculated as an average of all non-missing TSS scores between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 2. The range of TSS is from 0 to 24 units on a scale. The highest the score, the more severe symptoms a subject experiences. Negative change of TSS between baseline and visit 6 was expected (reduced symptoms), more negative change at visit 6 versus baseline represents better outcome of the study.
Measured: 10 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP administration)
Change From Baseline in Mean Total Symptom Score (TSS) After 5 Months of Treatment (Visit 4)
The change from baseline of the mean TSS at visit 4. The mean TSS at visit 4 will be calculated as an average of all non-missing TSS between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 4. The baseline will be calculated as an average of all non-missing TSS between 1 and 6 hours after start of EEC challenge at visit 2. The range of TSS is from 0 to 24 units on a scale. The highest the score, the more severe symptoms a subject experiences. Negative change of TSS between baseline and visit 4 was expected (reduced symptoms), more negative change at visit 4 versus baseline represents better outcome of the study.The highest the score, the more severe symptoms a subject experiences.
Measured: 5 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP administration)
Change From Baseline in Mean Total Nasal Symptom Score (TNSS) After 10 Months of Treatment (Visit 6)
The change from baseline of the mean TNSS at visit 6. The mean TNSS at visit 6 will be calculated as an average of all non-missing TNSS between 1 and 6 hours after start of EEC challenge at visit 6. The baseline will be calculated as an average of all non-missing TNSS between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 2. TNSS will be computed as the sum of individual scores for four nasal symptoms (running nose, congestion, itchy nose, and sneezing). Each of the four symptoms will be rated on a scale of 0-3 as follows: 0, none; 1, mild; 2, moderate; and 3, severe. The range of TNSS is from 0 to 12 units on a scale. The highest the score, the more severe symptoms a subject experiences.Negative change of TNSS between baseline and visit 6 was expected (reduced symptoms), more negative change at visit 6 versus baseline represents better outcome of the study.
Measured: 10 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP injection)
Change From Baseline in Mean Total Nasal Symptom Score (TNSS) After 5 Months of Treatment (Visit 4)
The change from baseline of the mean TNSS at visit 4. The mean TNSS at visit 4 will be calculated as an average of all non-missing TNSS between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 4. The baseline will be calculated as an average of all non-missing TNSS between 1 and 6 hours after start of during EEC challenge at visit 2. TNSS will be computed as the sum of individual scores for four nasal symptoms (running nose, congestion, itchy nose, and sneezing). Each of the four symptoms will be rated on a scale of 0-3 as follows: 0, none; 1, mild; 2, moderate; and 3, severe. The range of TNSS is from 0 to 12 units on a scale. The highest the score, the more severe symptoms a subject experiences. Negative change of TSS between baseline and visit 6 was expected (reduced symptoms), more negative change at visit 4 versus baseline represents better outcome of the study.
Measured: 5 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP injection)
Mean Combined Symptom and Medication Scores (CSMS) During the Grass Pollen Season.
The mean CSMS will be calculated as an average of all non-missing daily CSMS during the grass pollen season. Subjects that did not complete at least 75% of their diary data, and subjects who have been on holidays outside the region for more than 7 days during the actual grass pollen season will be excluded from the analysis. The daily CSMS will be computed according to the definition given by the EAACI Position Paper. The actual grass pollen season would start on the first of 3 consecutive days that have a grass pollen count ≥ 10 ppm3 per 24 hours and the season would end on the first of 3 consecutive days that have a grass pollen count < 10 ppm3 per 24 hours. The defined pollen season could consist of several separate periods that comply with this definition. The CSMS has a range from 0 to 6 and the higher the score, the more severe symptoms a subject is experiencing.
Measured: during the grass pollen season: estimated between 6 and 10 months after start of treatment at Visit 2
Change From Baseline in Serum Specific Immunoglobulin (IgE) Levels After 5 Months (Visit 4) and 10 Months (Visit 6) of Treatment
Changes from baseline in serum specific immunoglobulin levels (IgE) after after 5 months of treatment (Visit 4) and after 10 months of treatment (Visit 6). Measurements at visit 1 will be used as baseline.
Measured: 5 and 10 months after treatment start compared to first day of treatment (IgE at baseline measured at Visit 2, before IMP administration)
Change From Baseline in Serum Specific Immunoglobulin (IgG) Levels After 5 Months (Visit 4) and 10 Months (Visit 6) of Treatment
Changes from baseline in serum specific immunoglobulin levels (IgG ATG, IgG AP1 and IgG AP5) after after 5 months of treatment (Visit 4) and after 10 months of treatment (Visit 6). Measurements at visit 1 will be used as baseline.
Measured: 5 and 10 months after treatment start compared to first day of treatment (IgG at baseline measured at Visit 2, before IMP injection)
Change From Baseline in Serum Specific Immunoglobulin (IgG4) Levels After 5 Months (Visit 4) and 10 Months (Visit 6) of Treatment
Changes from baseline in serum specific immunoglobulin levels (IgG4 ATG, IgG4 AP1 and IgG4 AP5) after 5 months of treatment (Visit 4) and after 10 months of treatment (Visit 6). Measurements at visit 1 will be used as baseline.
Measured: 5 and 10 months after treatment start compared to first day of treatment (IgG4 at baseline measured at Visit 2, before IMP injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic RhinitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Couroux, MD, Principal investigator, Inflamax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556801
- Sponsor's protocol ID
- SP/0047
- Status last verified
- Aug 2019
- First submitted
- 31 Aug 2015
- Last updated
- 13 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Relative Efficacy and Safety of Immunotherapy With SUBLIVAC FIX Phleum Pratense in Grass Pollen-Allergic Subjects With IgE-Mediated Seasonal ARC
- ClinicalTrials.gov ID
- NCT02556801
- Acronym / sponsor ID
- SP/0047
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Keywords
- Sublingual immunotherapy, Dose range finding, Grass pollen, Allergic rhinitis/rhinoconjunctivitis, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety, tolerability and demonstrate a dose response signal using Total Symptom Score (TSS), based on challenges with grass pollen in an Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo.
The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.
Detailed description
The current dose range finding study with SP has been designed to test three different concentrations of SUBLIVAC FIX Phleum (SP) that includes 3 doses (10,000 AUN/mL; 40,000 AUN/mL; 80,000 AUN/mL) and placebo to demonstrate a dose response signal and to estimate the minimal effective dose of SP. The study will be conducted in the target population of seasonal allergic subjects in a fully validated Environmental Exposure Chamber (EEC) system. The EEC system is a facility that has temporal uniformity of airborne allergen (pollen) exposure to subjects. Use of the EEC ensures exposure to relatively consistent levels of allergen. This facility has been used in a number of immunotherapy trials and is an improved challenge model of AR compared to the previously used nasal provocation test. Treatment duration of this study is extended to 10 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SUBLIVAC FIX Phleum Prat. 0 AUN/ml | Placebo comparator | Biological: SUBLIVAC FIX Phleum Prat.42 subjects received placebo (SUBLIVAC FIX Phleum Pratense 0 AUN/ml) sublingually. Subjects will start with one drop and add one drop each consecutive day until the maintenance dose of 5 drops per day is reached. Next treatment at maintenance dose is continued during 10 months. |
| SUBLIVAC FIX Phleum Prat. 10,000 AUN/ml | Experimental | Biological: SUBLIVAC FIX Phleum Prat.42 subjects received SUBLIVAC FIX Phleum Pratense 10,000 AUN/ml) sublingually. Subjects will start with one drop and add one drop each consecutive day until the maintenance dose of 5 drops per day is reached. Next treatment at maintenance dose is continued during 10 months. |
| SUBLIVAC FIX Phleum Prat. 40,000 AUN/ml | Experimental | Biological: SUBLIVAC FIX Phleum Prat.40 subjects received SUBLIVAC FIX Phleum Pratense 40,000 AUN/ml sublingually. Subjects will start with one drop and add one drop each consecutive day until the maintenance dose of 5 drops per day is reached. Next treatment at maintenance dose is continued during 10 months. |
| SUBLIVAC FIX Phleum Prat. 80,000 AUN/ml | Experimental | Biological: SUBLIVAC FIX Phleum Prat.40 subjects received SUBLIVAC FIX Phleum Pratense 80,000 AUN/ml sublingually. Subjects will start with one drop and add one drop each consecutive day until the maintenance dose of 5 drops per day is reached. Next treatment at maintenance dose is continued during 10 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who signed informed consent.
- Subjects aged ≥18 and ≤65 years at signing of informed consent.
- Subjects with at least two-year clinical history of allergic rhinitis/rhinoconjunctivitis to grass pollen, with or without concomitant asthma (asthma must be controlled).
- Subjects with a forced expiratory volume at one second (FEV1) >70% of the predicted value as measured during screening or documented within 1 year of study start.
- Subjects with a positive skin prick test (SPT) (mean wheal diameter of at least 3 mm larger than the negative control; negative control should be <2 mm, histamine control should be positive (mean wheal diameter of at least 3 mm larger than the negative control)) for grass pollen assessed during screening or a documented positive response obtained within 1 year before screening.
Key exclusion criteria (22 listed)
- Subjects with (expected) clinically relevant symptoms at the timing of the scheduled EEC assessments at Visit 2 and Visit 6 due to concomitant sensitization i.e. positive SPT (mean wheal diameter of at least 3 mm larger than the negative control) and a history of allergic response to the causative allergen, at the discretion of the investigator.
- Patients with grass pollen induced asthma.
- Subjects who cannot tolerate the Baseline Challenge in the EEC.
- Subjects who received immunotherapy (SCIT or SLIT) with grass pollen allergens within the past 5 years.
- (Ongoing) allergen-specific immunotherapy with any allergen(s) during the study period.
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 |
|---|---|---|
| SUBLIVAC FIX Phleum Prat.sublingual daily administration | Biological | SUBLIVAC FIX Phleum Prat. 0 AUN/ml, SUBLIVAC FIX Phleum Prat. 10,000 AUN/ml, SUBLIVAC FIX Phleum Prat. 40,000 AUN/ml, SUBLIVAC FIX Phleum Prat. 80,000 AUN/ml |
Primary outcome
Mean Total Symptom Score (TSS) After 10 Months of Treatment (Visit 6) Compared to Placebo
Time frame: 10 months after treatment start (baseline - Visit 2)
The primary endpoint was the TSS after 10 months of treatment (at visit 6). The mean TSS at visit 6 was calculated as an average of all non-missing TSS scores between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 6. TSS was computed as the sum of individual scores for eight nasal and non-nasal symptoms (rhinorrhea, congestion, sneezing, itchiness, itchy/gritty eyes, tearing/watery eyes, red/burning eyes, and ear/palate itching). Each of eight symptoms was rated on a scale of 0-3 as follows: 0, none; 1, mild; 2, moderate; 3, severe. The range of TSS is from 0 to 24 units on a scale. The highest the score, the more severe symptoms a subject experiences. Negative change of TSS between baseline and visit 6 was expected (reduced symptoms), more negative change at visit 6 versus baseline represents better outcome of the study.
8 secondary outcomes
Change From Baseline in Mean Total Symptom Score (TSS) After 10 Months of Treatment (Visit 6)
Time frame: 10 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP administration)
Change From Baseline in Mean Total Symptom Score (TSS) After 5 Months of Treatment (Visit 4)
Time frame: 5 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP administration)
Change From Baseline in Mean Total Nasal Symptom Score (TNSS) After 10 Months of Treatment (Visit 6)
Time frame: 10 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP injection)
Change From Baseline in Mean Total Nasal Symptom Score (TNSS) After 5 Months of Treatment (Visit 4)
Time frame: 5 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP injection)
Mean Combined Symptom and Medication Scores (CSMS) During the Grass Pollen Season.
Time frame: during the grass pollen season: estimated between 6 and 10 months after start of treatment at Visit 2
Change From Baseline in Serum Specific Immunoglobulin (IgE) Levels After 5 Months (Visit 4) and 10 Months (Visit 6) of Treatment
Time frame: 5 and 10 months after treatment start compared to first day of treatment (IgE at baseline measured at Visit 2, before IMP administration)
Change From Baseline in Serum Specific Immunoglobulin (IgG) Levels After 5 Months (Visit 4) and 10 Months (Visit 6) of Treatment
Time frame: 5 and 10 months after treatment start compared to first day of treatment (IgG at baseline measured at Visit 2, before IMP injection)
Change From Baseline in Serum Specific Immunoglobulin (IgG4) Levels After 5 Months (Visit 4) and 10 Months (Visit 6) of Treatment
Time frame: 5 and 10 months after treatment start compared to first day of treatment (IgG4 at baseline measured at Visit 2, before IMP injection)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Couroux, MD principal investigator
Inflamax
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUBLIVAC FIX Phleum Prat. in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 1 site in Canada.
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 7 inclusion and 22 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: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Total Symptom Score (TSS) After 10 Months of Treatment (Visit 6) Compared to Placebo (time frame: 10 months after treatment start (baseline - Visit 2)). 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 13 Sep 2019.