Rhinitis, Allergic, SeasonalPhase 2/3NCT04687059
An Exploratory Study of PQ Grass 27600 SU
A Phase 2/3 study testing PQ Grass in people with Rhinitis, Allergic, Seasonal, run by Allergy Therapeutics at 14 sites in 2 countries.
Trial summary
PQGrass309 is aimed at exploring the expected average treatment effect of PQ Grass 27600 SU cumulative dose on symptom and medication score in a field setting. The study will enrol adult subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- PQ Grass
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 19 Oct 2020to 28 Oct 2021
- Phase
- Phase 2/3
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
- Informed Consent
- Capable of giving signed informed consent and demonstrates willingness to comply with the requirements and restrictions listed in the ICF and study protocol and to attend required study visits.
- Subject who has signed and dated the ICF.
- Age:
- 18 to 65 years of age inclusive, at the time of signing the ICF.
- Sex / Contraceptive requirements:
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- Male or female.
- Female subjects who are not of childbearing potential (defined as at least 12 months natural spontaneous amenorrhoea, or at least 6 weeks following surgical menopause) or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol.
- Subjects and general health characteristics:
- Good general health, as determined by the investigator, based on a medical evaluation, including medical history, physical examination, and laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Positive history of moderate to severe symptoms of seasonal allergic rhinitis and/or rhinoconjunctivitis ascribed to grass (Pooideae) pollen exposure that required repeated use of antihistamines, nasal corticosteroids, and/or leukotriene modifiers for relief of symptoms during the last 2 consecutive seasons prior to the study, confirmed by subject records.
- Please note: Subjects with asthma may be included, but the asthma must be well controlled (according to current Global Initiative for Asthma {GINA} guidelines [GINA, 2020]).
- A positive SPT for grass pollen (wheals [longest diameter] ≥3 mm and histamine ≥3 mm) and a negative SPT to the negative control (wheal diameter =0) at screening.
- Grass specific IgE class ≥2 as documented by an ImmunoCAP test at screening.
- FEV1 ≥80% of predicted, with a FEV1/FVC ratio ≥70% and (PEFR) ≥75% predicted at screening.
- Subjects who have no suspicion or symptoms of SARS-CoV-2 infection (as assessed by the investigator) or who have had no contact with a confirmed case of COVID-19 in the past 2 weeks prior to screening and randomisation.
Who cannot join
- Medical conditions:
- Pregnant or lactating subject.
- Moderate to severe allergy symptoms during the screening and treatment periods, and/or GPS caused by perennial allergens or seasonal allergens (other than grass) as verified by medical history and positive SPT.
- Exception: screening, treatment and collection of eDiary data can be conducted outside of the pollen season(s) of concern or perennial allergies are irrelevant due to avoidance measures (e.g., cats and dog allergy).
- Subjects with a positive SPT at US and EU sites in regions with relevant southern grass (Bahia grass, Bermuda grass or Johnson grass) exposure.
- Moderate to severe symptoms during the 3 years prior to Visit 1 to another seasonal or perennial allergen not tested in the SPT that cannot be avoided during the study and the symptoms of which may interfere with administration of treatment and /or impact the data collected, as determined by the investigator.
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- Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
- History of autoimmune disease including Hashimoto's thyroiditis or other immunological disorder or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, hematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator may pose a safety risk or compromise the interpretation of efficacy of the study treatment.
- Presence of severe or uncontrolled or partly controlled asthma as defined in the GINA guidelines (GINA 2020) or asthma that requires more than a daily dose above 400 mcg of inhaled budesonide or equivalent.
- Emergency room visit or hospitalisation for asthma in the 12 months prior to screening and randomisation or any history of a life-threatening asthma attack.
- Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
- Presence of nasal polyps and/or chronic sinusitis.
- Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis, which could interfere with the evaluation of CPT.
- Eye surgery within the past 6 months.
- Presence of any skin conditions (e.g. skin abnormalities, tattoos) which might interfere with the interpretation of the SPT results.
- Clinical history of Type I diabetes. Subjects with well-controlled Type II diabetes will be allowed to participate at the discretion of the investigator.
- Any acute infection (including upper respiratory tract infections in the 14 days prior to Visit 2), which in the opinion of the investigator may pose a safety risk to the subject.
- Clinical history of severe or serious systemic reaction in response to AIT treatment in the past.
- Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
- Clinical history of allergy, hypersensitivity or intolerance to the excipients of the IMP.
- Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
- Prior/concomitant therapy:
- History of any allergen SIT.
- Inability to adhere to the washout periods for Prohibited Medications/Therapies with respect to Visit 1/1a and to refrain from using the medications indicated until after Visit 15.
- Treatment with a preparation containing MPL (e.g., Cervarix, Shingrix, Fendrix) within 2 years prior to Visit 1 and until after completion of Visit 15 (with the exception of the IMP).
- Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated such as in subjects with hyperthyroidism, uncontrolled hypertension, cardiac arrhythmias, closed angle glaucoma or subjects taking other sympathomimetic).
- Previous history of epinephrine device use.
- β-blocker medication (including eye drops), for any indication.
- Monoamine oxidase inhibitors and tricyclic antidepressants. (Tricyclic antidepressants should be avoided at least 2 weeks prior to screening).
- Any previous therapy (within 12 months prior to screening) or current therapy with anti IgE (e.g., Xolair) or anti-interleukins (e.g., mepolizumab) or any other therapy with a biologic agent.
- Unable to refrain from any vaccination (including influenza and any potential vaccine for COVID-19) during the study (unless administered more than 30 days prior to randomisation). Please note: Emergency vaccinations (e.g., tetanus due to injury) can be administered at any time.
- Current or past therapy (within the previous 5 years) with immunosuppressant drugs or immunomodulatory biologics.
- Other exclusions
- Clinical history of drug or alcohol abuse which, in the investigator's opinion, could interfere with the subject's ability to participate in the study.
- Participation in a clinical research trial with any IMP within 4 weeks of Visit 1 or concomitantly with this study
- Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the study site, Sponsor, Sponsor's representative, or another individual who has access to the study protocol.
- Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.
- Subjects likely to have prolonged periods of absence (e.g., business or personal travel) during the GPS defined as:
- Absence of 22 days or more in similar or mixed geographic regions as determined by the investigator, with no single trip in a similar geographical region exceeding 14 days and no single trip in a non-similar geographical region exceeding 7 days,
- Absence of 15 days or more in non-similar geographic regions as determined by the investigator, with no single trip exceeding 7 days.
- Have changed residence between geographical regions since the last GPS. Exception: the old and new residences are in the same or similar geographical region as determined by the investigator.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States8 sites
Allergy Partners of Western North Carolina
Asheville, North Carolina, 28801
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
Smith Allergy & Asthma Specialists
Cortland, New York, 13045
Allergy Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, 53228
Corning Center for Clinical Research
Horseheads, New York, 14845
Allergy and Asthma Associates of Bluegrass
Lexington, Kentucky, 40509
Atlantic Research Center, LLC
Ocean Township, New Jersey, 07712
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21236
Germany6 sites
Universitatsmedizin Berlin - Charite Campus Mitte - Allergie Centrum Charite
Berlin
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden
ENT RESEARCH - Institut für klinische Studien
Essen
Medaimun GmbH
Frankfurt am Main
Hamburger Institut für Therapieforschung GmbH
Hamburg
Studienzentrum Dr. Sabine Laßmann
Saalfeld
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Exploratory Study to Explore the Efficacy and Safety of PQ Grass 27600 SU in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen Exposure
PQGrass309 is aimed at exploring the expected average treatment effect of PQ Grass 27600 SU cumulative dose on symptom and medication score in a field setting. The study will enrol adult subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure.
Read the detailed description
PQGrass309 is a randomised, double-blind, placebo-controlled exploratory study to explore the efficacy and safety of PQ Grass 27600 SU in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure. The study is expected to be conducted in the United States (US) and the European Union (EU).
The aim of this exploratory field study is to explore amongst others the following:
- The efficacy and safety (up to 6 months following treatment) of a cumulative dose of 27600 standardised units (SU) of PQ Grass in the treatment of grass pollen allergy.
- The expected average treatment effect on combined symptom and medication score.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- PQ Grass, Active Placebo, Standard Placebo
- Keywords
- PQ Grass, Seasonal Allergic Rhinitis or Rhinoconjunctivitis
- 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.
PQ GrassBiological
Suspension for injection
Active PlaceboDrug
Also called Placebo containing MCT
Suspension for injection
Standard PlaceboDrug
Also called Placebo without MCT
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| PQ Grass Conventional Dosing Regimen | Experimental | Cumulative dose 27600 SU Receives: Biological: PQ Grass |
| PQ Grass Extended Dosing Regimen | Experimental | Cumulative dose 27600 SU Receives: Biological: PQ Grass |
| Active Placebo | Placebo comparator | Suspension for injection Receives: Drug: Active Placebo |
| Standard Placebo | Placebo comparator | Solution for injection Receives: Drug: Standard Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSMS (Combined Symptom and Medication Score) Averaged Over the Peak Grass Pollen Season (GPS)
The daily CSMS is calculated as the sum of the daily Symptom Score (dSS) and the daily Medication Score (dMS).
The dSS component of the CSMS is calculated as the sum of 6 individual symptom (2 conjunctival and 4 nasal) scores, each with a range of 0 to 3 points and divided by 6, and therefore has a total range between 0 and 3.
The dMS is a score assigned according to the step of relief medication used in a day (from 0: no relief medication to 3: oral corticosteroids with step and step 2 medications).
The daily CSMS has a range between 0 and 6. The average CSMS over the peak GPS will be calculated as sum of the daily CSMS within the peak GPS divided by the number of days of the peak GPS where the CSMS has been collected. Higher values in the scale represent worse outcomes.
Measured: Measures collected approximately over 2-5 weeks (peak GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Secondary outcomes (24)
CSMS Averaged Over the Entire (or Truncated) GPS
The daily CSMS is calculated as the sum of the daily Symptom Score (dSS) and the daily Medication Score (dMS).
The dSS component of the CSMS is calculated as the sum of 6 individual symptom (2 conjunctival and 4 nasal) scores, each with a range of 0 to 3 points and divided by 6, and therefore has a total range between 0 and 3.
The dMS is a score assigned according to the step of relief medication used in a day (from 0: no relief medication to 3: oral corticosteroids with step and step 2 medications).
The daily CSMS has a range between 0 and 6. The average CSMS over the entire (or truncated) GPS will be calculated as sum of the daily CSMS within the peak GPS divided by the number of days of the GPS where the CSMS has been collected. Higher values in the scale represent worse outcomes.
Measured: Measures collected approximately over 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Total Combined Score (TCS) Averaged Over the Peak GPS
The daily TCS was the sum of the dSS and dMS calculated from the data recorded in the eDiary.
For the dSS 6 individual symptoms were assessed: conjunctival symptoms (2 items) and nasal symptoms (4 items). Each item was scored on a 4-point severity scale (0 = no symptoms, 3 = severe symptoms). The dSS was calculated as the sum of the scores for the 6 indicidual symptoms, ranging from 0 to 18.
For the dMS was rated on a scale from 0 to 20, depending on the relief medication use.
Higher scores in TCS are related to worse outcomes.
Measured: Measures collected approximately over 2-5 weeks (peak GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
TCS Averaged Over Entire (or Truncated) GPS
The daily TCS was the sum of the dSS and dMS calculated from the data recorded in the eDiary.
For the dSS 6 individual symptoms were assessed: conjunctival symptoms (2 items) and nasal symptoms (4 items). Each item was scored on a 4-point severity scale (0 = no symptoms, 3 = severe symptoms). The dSS was calculated as the sum of the scores for the 6 indicidual symptoms, ranging from 0 to 18.
The dMS was rated on a scale from 0 to 20, depending on the relief medication use: Score = 0, No relief medication used = 0 up to Score 20 = use of oral corticosteroids.
Higher scores in TCS are related to worse outcomes.
Measured: Measures collected approximately over 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Daily Symptom Score (dSS) of the CSMS Averaged Over the Peak and Entire (or Truncated) GPS
The dSS component of the CSMS was calculated as the sum of 6 individual symptom (2 conjunctival and 4 nasal) scores, each with a range of 0 to 3 points and divided by 6, and therefore has a total range between 0 and 3.
Higher scores are related to worse outcomes.
Measured: Measures collected approximately over 2-5 weeks (peak GPS) or 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection).
Daily Medication Score (dMS) of the CSMS Averaged Over the Peak and Entire (or Truncated) GPS
dMS of the CSMS consists on a score with a range from 0 to 3: Score 0 (no relief medication) to 3 (highest step relief medication) per day; based on at least 1 dose of the medication of the highest step taken that day. Higher scores are related to worse outcomes.
Measured: Measures collected approximately over 2-5 weeks (peak GPS) or 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection).
dSS of the TCS Averaged Over the Peak GPS and Entire (or Truncated) GPS
The dSS of the TCS is calculated as the sum of the scores (0-No symptoms to 3-Severe symptoms) for the 6 individual symptoms (i.e. ranging from 0 to 18). Higher scores are related to worse outcomes.
Measured: Measures collected approximately over 2-5 weeks (peak GPS) or 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection)
dMS of the TCS Averaged Over the Peak GPS and Entire (or Truncated) GPS
The dMS of the TCS was rated on a scale from 0 to 20 depending on the use of relief medication: Score = 0, No relief medication used = 0 up to Score 20 = use of oral corticosteroids. Higher values are related to worse outcomes.
Measured: Measures collected approximately over 2-5 weeks (peak GPS) or 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection)
Correlation Between TSS During CPT, CSMS, TCS, dSS (for CSMS and TCS) and dMS (for CSMS and TCS) Over the Peak and Entire (or Truncated) GPS for Subjects With a Positive CPT at Baseline.
Variables evaluated for correlation:
- Average combined score medication (CSMS) over the peak GPS or entire/truncated GPS
- Average Total combined score (TCS) over the peak GPS or entire/truncated GPS
- dSS (daily symptom score) of CSMS (CSMS.dSS) over the peak GPS or entire/truncated GPS
- dMS (daily medication score) of CSMS (CSMS-dMS) over the peak GPS or entire/truncated GPS
- dSS of TCS (TCS-dSS) over the peak or entire/truncated GPS
- dMS of TCS (TCS-dMS) over the peak or entire/truncated GPS
- Change from baseline in Total symptom score (TSS) during CPT (Conjunctival provocation test)
The correlation between the above variables were explored using linear regression models.
Outcomes are presented as Mean Squared Errors, representing the strength of the correlation, CI numbers not available. Low values represent stronger correlation between the two variables.
Measured: Measures collected approximately over 2-5 weeks (peak GPS) or 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection)
Number of Well Days and Severe Days During the Peak and Entire (or Truncated) GPS.
A "well day" was defined based on CSMS as a day with:
- No use of relief medication on the particular day,
- And a total symptom score ≤2 out of 18 A "severe day" was based on CSMS and defined as a day with a symptom score of 3 in any of the 6 rhinitis/rhinoconjunctivitis symptoms.
The probability of a well day or a severe day was analyzed using data on a by-day level per subject using generalized estimating equation (GEE) or similar approaches as appropriate.
Well days and severe days were assessed during the peak GPS and entire (or truncated) GPS.
Measured: Measures collected approximately over 2-5 weeks (peak GPS) or 10 weeks (entire/truncated GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection)
Serum Ig Responses (Change in Total IgE and Grass-specific IgE From Baseline to Visit 12 and Visit 15)
Immunological measurements (total IgE and grass-specific IgE) and their changes between screening and post-treatment were analyzed descriptively. The change from baseline in immunoglobulin measurements was additionally analyzed using analysis of covariance (ANCOVA), including treatment groups and with baseline as covariate.
Measured: Baseline (Visit 2), Visit 12 (2 weeks before start of the GPS) and visit 15 (end of the GPS). The exact time frame depended on the GPS start and end dates for each region, and visit 15 was usually in the range between 24 and 32 weeks after screening
Change in Serum Ig Responses (Change in Grass-specific IgG4 From Baseline to Visit 12 and Visit 15)
Immunological measurements (grass-specific IgG4) and their changes between screening and post-treatment were analyzed descriptively. The change from baseline in immunoglobulin measurements was additionally analyzed using analysis of covariance (ANCOVA), including treatment groups and with baseline as covariate.
Measured: Baseline (Visit 2), Visit 12 (2 weeks before start of the GPS) and visit 15 (end of the GPS). The exact time frame depended on the GPS start and end dates for each region, and visit 15 was usually in the range between 24 and 32 weeks after screening
RQLQ(S) During the Peak GPS
Rhinoconjunctivitis quality of life was assessed using the Rhinoconjunctivitis Quality of Life Questionnaire with Standardised Activities (RQLQ[S]). The RQLQ(S) comprises 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems, and emotional function). Each question is scored on a scale from 0 to 6.
Score is calculated as a mean of the 28 responses, with a range from 0 to 6. Higher scores are related with worse outcomes.
Measured: Measures were collected approximately over 2-5 weeks (peak GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Frequency, Severity and Relationship of AEs to Treatment
Number of subjects with at least one event of the specified AE type. The frequency, relationship and severity of AEs will be assessed within each treatment group.
Note: TEAE (treatment emergent adverse events) are reported in the Adverse Event section.
Measured: Up to 1 year
Frequency of AEs Leading to Premature Discontinuation From Treatment or Study
Number of participants who prematurely discontinued from treatment or study due to AEs.
Measured: Up to 1 year
Frequency of AESI
Number of participants with Adverse events of special interest (AESI). Suspected AESIs in this study were defined as signs and symptoms indicative of new-onset auto-immune or neuroinflammatory disorders.
Measured: Up to 1 year
Number of Participants With Changes in Serum Chemistry Between Screening and Visit 15
Alert ranges were defined for laboratory values (Glucose, Sodium, Uric acid, Urea, Potassium, Calcium, Creatinine, Chloride, Total protein, Phosphorus, Cholesterol, Albumin, Total Bilirubin, Alkaline phosphatase, LDH, AST, ALT, GGT, CRP) lying outside the normal range to a clinically relevant degree.
Shift tables comparing the values at baseline to the values at the final visit were created for each variable.
Measured: At Screening (Visit 1) and at the end of pollen season (Visit 15). The exact time frame depended on the GPS start and end dates for each region, however, visit 15 usually ranged between week 24 and week 32 from screening
Number of Participants With Changes in Hematology Between Screening and Visit 15
Alert ranges were defined for laboratory values (Haemoglobin, haematocrit, total WBC and differentials, total RBC, RBC indices, and platelet count) lying outside the normal range to a clinically relevant degree.
Shift tables comparing the values at baseline to the values at the final visit were created for each urinalysis parameter.
Measured: At Screening (Visit 1) and at the end of pollen season (Visit 15). The exact time frame depended on the GPS start and end dates for each region, however, visit 15 usually ranged between week 24 and week 32 from screening
Number of Participants With Changes in Urinalysis Between Screening and Visit 15
pH, Protein, Glucose, Ketones, Bilirubin, Blood, Nitrite, Urobilinogen, Leukocytes were determined in urine.
Alert ranges were defined for laboratory values lying outside the normal range to a clinically relevant degree.
Shift tables comparing the values at baseline to the values at the final visit were created for each urinalysis parameter.
Measured: At Screening (Visit 1) and at the end of pollen season (Visit 15). The exact time frame depended on the GPS start and end dates for each region, however, visit 15 usually ranged between week 24 and week 32 from screening (baseline)
Baseline and Changes in PEFR (Only in Subjects With Past or Current Asthma) at All Treatment Visits
PEFR - peak expiratory flow rate. Baseline measure of PEFR was performed in all subjects. Only in subjects with past or current asthma, PEFR was performed at Visits 2 (baseline) to 11, prior to and approximately 30 to 60 minutes following study drug administration. At Visit 1 (screening), the PEFR should be ≥75% predicted for subjects to be eligible for the study.
Note that the exact time frame for each visit depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Measured: At baseline (Visit [V]2) only for all subjects, and also at V3 (V2 +~1 week [wk]), V4 (V3+~1wk), V5 (V4+~4wk), V6 (V5+~3wk), V7 (V6+~1wk), V8 (V7+~1wk), V9 (V8+~1wk), V10 (V9+~1wk) and V11 (~3-7wk before GPS) for subjects with past or current asthma
Changes in Vital Signs (Body Temperature) Between Baseline and All Treatment Visits
Body temperature was measured after the subject has been in the supine position for at least 5 minutes at all visits: Visit 1 to Visit 15. At Visits 2 (baseline) to 11, vital sign measurements were performed before and 30 to 60 minutes following study drug administration. Changes in temperature values reported only post-injection. All vital signs-related information will be listed by subject, visit and timepoint.
The exact time frame for each visit depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Measured: From baseline (Visit 2) to Visit 15 (usually between week 24 and 32 from screening)
Changes in Vital Signs (Respiratory Rate) Between Baseline and All Treatment Visits
Respiratory rate was measured after the subject has been in the supine position for at least 5 minutes at Visit 1 to Visit 15. At Visits 2 (baseline) to 11, vital sign measurements were performed before and 30 to 60 minutes following study drug administration. All vital signs-related information will be listed by subject, visit and timepoint.
The exact time frame for each visit depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Measured: From baseline (Visit 2) to Visit 15 (usually between week 24 and 32 from screening)
Changes in Vital Signs (Pulse Rate) Between Baseline and All Treatment Visits
Pulse rate was measured after the subject has been in the supine position for at least 5 minutes at Visit 1 to Visit 15. At Visits 2 (baseline) to 11, vital sign measurements were performed before and 30 to 60 minutes following study drug administration. All vital signs-related information will be listed by subject, visit and timepoint.
The exact time frame for each visit depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Measured: From baseline (Visit 2) to Visit 15 (usually between week 24 and 32 from screening)
Changes in Vital Signs (Systolic Blood Pressure) Between Baseline and All Treatment Visits
Systolic blood pressure were measured after the subject has been in the supine position for at least 5 minutes at Visit 1 to Visit 15. At Visits 2 (baseline) to 11, vital sign measurements were performed before and 30 to 60 minutes following study drug administration. All vital signs-related information will be listed by subject, visit and timepoint.
The exact time frame for each visit depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Measured: From baseline (Visit 2) to Visit 15 (usually between week 24 and 32 from screening)
Changes in Vital Signs ( Diastolic Blood Pressure) Between Baseline and All Treatment Visits
Diastolic blood pressure were measured after the subject has been in the supine position for at least 5 minutes at Visit 1 to Visit 15. At Visits 2 (baseline) to 11, vital sign measurements were performed before and 30 to 60 minutes following study drug administration. All vital signs-related information will be listed by subject, visit and timepoint.
The exact time frame for each visit depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
Measured: From baseline (Visit 2) to Visit 15 (usually between week 24 and 32 from screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start19 Oct 2020
- Primary completion18 Aug 2021
- Study completion28 Oct 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pieter-Jan de Kam, Ph.D, Study director, Global R&D - Clinical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687059
- Sponsor's protocol ID
- PQGrass309
- Other IDs
- 2020-000408-13
- Status last verified
- Apr 2026
- First submitted
- 8 Oct 2020
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Layhadi JA, Starchenka S, De Kam PJ, Palmer E, Wu LYD, Keane ST, Fulton WT, Hikmawati P, Meng X, Filipaviciute P, Cutrina Pons A, Oluwayi K, Lis K, Armfield O, Skinner MA, Heath MD, Hewings SJ, Kramer MF, Shamji MH. Modulation of Cellular, Molecular, and Humoral Responses by PQ Grass 27,600 SU for the Treatment of Seasonal Allergic Rhinitis: A Randomised Double Blind Placebo Control Exploratory Field Study. Allergy. 2026 Jan;81(1):232-247. doi: 10.1111/all.16640. Epub 2025 Jul 8.
PubMed 40626378