Trial Outcomes & Findings for Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen (NCT NCT05540717)

Last Updated: 2025-04-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

555 participants

Primary outcome timeframe

dSS and dMS are recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then CSMS is adjusted to the Peak GPS, which depends on the GPS start and end dates for each region

Results posted on

2025-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	PQ Grass 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo 6 subcutaneous injections of placebo Placebo: Solution for injection
Overall Study STARTED	278	277
Overall Study COMPLETED	266	262
Overall Study NOT COMPLETED	12	15

Reasons for withdrawal

Reasons for withdrawal
Measure	PQ Grass 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo 6 subcutaneous injections of placebo Placebo: Solution for injection
Overall Study Lost to Follow-up	2	5
Overall Study Withdrawal by Subject	6	6
Overall Study Sponsor request	1	0
Overall Study Study terminated by Sponsor for site 202 moving to a different location	3	3
Overall Study Other	0	1

Baseline Characteristics

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PQ Grass n=278 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=277 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection	Total n=555 Participants Total of all reporting groups
Age, Continuous	32.8 years STANDARD_DEVIATION 10.02 • n=5 Participants	34.8 years STANDARD_DEVIATION 10.34 • n=7 Participants	33.8 years STANDARD_DEVIATION 10.23 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	126 Participants n=7 Participants	249 Participants n=5 Participants
Sex: Female, Male Male	155 Participants n=5 Participants	151 Participants n=7 Participants	306 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	274 Participants n=5 Participants	275 Participants n=7 Participants	549 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	268 Participants n=5 Participants	265 Participants n=7 Participants	533 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Austria	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants
Region of Enrollment Hungary	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	34 participants n=7 Participants	67 participants n=5 Participants
Region of Enrollment Czechia	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants
Region of Enrollment Poland	77 participants n=5 Participants	76 participants n=7 Participants	153 participants n=5 Participants
Region of Enrollment Germany	121 participants n=5 Participants	121 participants n=7 Participants	242 participants n=5 Participants
Alcohol consumption Never	56 Participants n=5 Participants	59 Participants n=7 Participants	115 Participants n=5 Participants
Alcohol consumption Currently Daily	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Alcohol consumption Currently Weekly	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Alcohol consumption Currently Monthly	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Alcohol consumption Currently Occasionally	144 Participants n=5 Participants	146 Participants n=7 Participants	290 Participants n=5 Participants
Alcohol consumption Previously Daily	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Alcohol consumption Previously Weekly	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Alcohol consumption Previously Monthly	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Alcohol consumption Previously Occasionally	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Smoking habit Never	209 Participants n=5 Participants	204 Participants n=7 Participants	413 Participants n=5 Participants
Smoking habit Currently Daily	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Smoking habit Currently Weekly	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Smoking habit Currently Monthly	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Smoking habit Currently Occasionally	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Smoking habit Previously Daily	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Smoking habit Previously Weekly	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Smoking habit Previously Monthly	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Smoking habit Previously Occasionally	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Height	174.1 cm STANDARD_DEVIATION 9.70 • n=5 Participants	173.7 cm STANDARD_DEVIATION 9.72 • n=7 Participants	173.9 cm STANDARD_DEVIATION 9.70 • n=5 Participants
Weight	80.44 Kg STANDARD_DEVIATION 19.435 • n=5 Participants	79.69 Kg STANDARD_DEVIATION 17.327 • n=7 Participants	80.07 Kg STANDARD_DEVIATION 18.459 • n=5 Participants
Body Mass Index (BMI)	26.45 Kg/m^2 STANDARD_DEVIATION 5.874 • n=5 Participants	26.32 Kg/m^2 STANDARD_DEVIATION 5.018 • n=7 Participants	26.39 Kg/m^2 STANDARD_DEVIATION 5.459 • n=5 Participants

PRIMARY outcome

Timeframe: dSS and dMS are recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then CSMS is adjusted to the Peak GPS, which depends on the GPS start and end dates for each region

Population: Full analysis set (FAS)

Outcome measures

Outcome measures
Measure	PQ Grass n=278 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=277 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Combined Symptom and Medication Score (CSMS) Averaged Over the Peak Grass Pollen Season (GPS)	1.08 score on a scale Interval 0.84 to 1.3	1.34 score on a scale Interval 1.12 to 1.57

SECONDARY outcome

Timeframe: dSS and dMS are recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then CSMS is adjusted to the entire GPS, which depends on the GPS start and end dates for each region

Population: FAS

6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms) and combined with relief medication use assessed using a 4 point severity scale (0=No relief medication, 1=anti-histamine use, 2=nasal corticosteroid use, and 3=oral corticosteroid use)

Outcome measures

Outcome measures
Measure	PQ Grass n=278 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=277 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Combined Symptom and Medication Score (CSMS) Averaged Over the Entire (or Truncated) Grass Pollen Season (GPS)	0.99 units on a scale Standard Deviation 0.786	1.23 units on a scale Standard Deviation 0.965

SECONDARY outcome

Timeframe: dMS of the CSMS was recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then dMS is adjusted to the peak or entire GPS

Population: FAS

The dMS is calculated from the daily use of relief medication. Scores are assigned following the scheme: Score 0: no relief medication used Score 1: Oral antihistamine/Ocular antihistamine Score 2: Intranasal corticosteroid with Step 1 medication(s) Score 3: Oral corticosteroids with Step 1 and Step 2 medications The maximum dMS corresponds to a score of 3, which would indicate worse symptoms in the patient.

Outcome measures

Outcome measures
Measure	PQ Grass n=278 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=277 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Daily Medication Score (dMS) Component of the CSMS Averaged Over the Peak GPS and Entire (or Truncated) GPS dMS averaged over the Entire (Truncated) GPS	0.33 score on a scale Standard Deviation 0.393	0.46 score on a scale Standard Deviation 0.485
Daily Medication Score (dMS) Component of the CSMS Averaged Over the Peak GPS and Entire (or Truncated) GPS dMS averaged over the peak GPS	0.47 score on a scale Standard Deviation 0.554	0.59 score on a scale Standard Deviation 0.589

SECONDARY outcome

Timeframe: dSS of the CSMS was recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then dMS is adjusted to the peak or entire GPS

Population: FAS

dSS score is based on the sum of the score of 6 symptoms using a 4-point severity scale as follows: 0 = No symptoms 1. = Mild symptoms 2. = Moderate symptoms 3. = Severe symptoms The dSS is calculated as the sum of the scores for the 6 individual symptoms, divided by 6. Higher values in the scale indicate worse symptoms.

Outcome measures

Outcome measures
Measure	PQ Grass n=278 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=277 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Daily Symptom Score (dSS) Component of the CSMS Averaged Over the Peak GPS and Entire (or Truncated) GPS dSS averaged over peak GPS	0.82 score on a scale Standard Deviation 0.589	0.95 score on a scale Standard Deviation 0.640
Daily Symptom Score (dSS) Component of the CSMS Averaged Over the Peak GPS and Entire (or Truncated) GPS dSS Averaged Over the Entire (Truncated) GPS	0.65 score on a scale Standard Deviation 0.478	0.78 score on a scale Standard Deviation 0.564

SECONDARY outcome

Timeframe: RQLQ(s) is performed at Visit 2 (wk 2-8), Visit 9 (wk 18-31) and Visit 10 (wk 23-36).

Population: FAS - RQLQ data was not available for all participants in the FAS. Number of subjects with RQLQ data is detailed.

RQLQ(S) is a health-related quality of life instrument that measures the functional impairments that are most troublesome to adults. It is measured in a 7-point scale (0 = not impaired at all - 6 = severely impaired) with higher scores reflecting a lower quality of life.

Outcome measures

Outcome measures
Measure	PQ Grass n=137 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=123 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ(S)) Measured Within the Peak GPS	1.399 score on a scale Standard Deviation 1.0718	1.903 score on a scale Standard Deviation 1.2447

SECONDARY outcome

Timeframe: Serum grass-specific IgG4 was measured at Visit 1 (baseline) and Visit 7 (wk 12-25)

Population: FAS - IgG4 values were not available for all participants. Number of subjects with available data is detailed.

Serum grass-specific IgG4 was measured at baseline and at visit 7

Outcome measures

Outcome measures
Measure	PQ Grass n=229 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=243 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Change in Serum Grass-specific IgG4 (Immunoglobulin G4) From Baseline to Visit 7.	3.95 mg/L Interval 3.44 to 4.46	-0.05 mg/L Interval -0.54 to 0.045

SECONDARY outcome

Timeframe: dMS and dSS was recorded daily between Visit 8 (wk 16-29) and Visit 11 (wk 28-41). Then number of well days was calculated during peak GPS.

Population: FAS - Determination of well days was not possible for all participants. Number of subjects with data available is detailed.

A "well day" was defined based on CSMS as a day with: * No use of relief medication on the particular day, i.e., CSMS-dMS = 0; * And a total dSS, i.e., CSMS-dSS ≤ 2 out of 18 of the raw scores.

Outcome measures

Outcome measures
Measure	PQ Grass n=265 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=266 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Number of Well Days During the Peak GPS	6.6 days Standard Deviation 8.16	5.5 days Standard Deviation 7.11

SECONDARY outcome

Timeframe: From visit 1 (baseline) to last follow-up call (week 46)

Number of subjects with at least one event of the specified AE type

Outcome measures

Outcome measures
Measure	PQ Grass n=279 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=276 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Frequency, Severity and Relationship of AEs (Adverse Event) to Treatment Total AEs	232 number of subjects	163 number of subjects
Frequency, Severity and Relationship of AEs (Adverse Event) to Treatment Definitely related AEs	144 number of subjects	53 number of subjects
Frequency, Severity and Relationship of AEs (Adverse Event) to Treatment Probably related AEs	34 number of subjects	23 number of subjects
Frequency, Severity and Relationship of AEs (Adverse Event) to Treatment Possibly related AEs	34 number of subjects	31 number of subjects
Frequency, Severity and Relationship of AEs (Adverse Event) to Treatment Unlikely related AEs	1 number of subjects	4 number of subjects
Frequency, Severity and Relationship of AEs (Adverse Event) to Treatment Not related AEs	19 number of subjects	43 number of subjects

SECONDARY outcome

Timeframe: From visit 1 (baseline) to last follow-up call (week 46)

Number of subjects with at least one event of the specified AE type

Outcome measures

Outcome measures
Measure	PQ Grass n=279 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=276 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Frequency of AEs Leading to Premature Discontinuation From Treatment or Clinical Trial AE leading to premature discontinuation from treatment	4 number of subjects	5 number of subjects
Frequency of AEs Leading to Premature Discontinuation From Treatment or Clinical Trial AE leading to premature discontinuation from clinical trial	1 number of subjects	3 number of subjects

SECONDARY outcome

Timeframe: From visit 1 (baseline) to last follow-up call (week 46)

Number of subjects with at least one event of the specified AE type

Outcome measures

Outcome measures
Measure	PQ Grass n=279 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=276 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Frequency of AESI (Adverse Events of Special Interest)	0 number of subjects	0 number of subjects

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Population: SAF - One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo. Safety results are based on treatment received. Serum chemistry was not available for all subjects, the number of available subjects for each analyte is detailed.

Outcome measures

Outcome measures
Measure	PQ Grass n=258 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=258 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Serum Chemistry Values (Sodium, Potassium and Chloride) Between Baseline and Visit 11 Serum potassium change	-0.05 mmol/L Standard Deviation 0.464	-0.04 mmol/L Standard Deviation 0.484
Changes in Serum Chemistry Values (Sodium, Potassium and Chloride) Between Baseline and Visit 11 Serum chloride change	0.6 mmol/L Standard Deviation 2.04	0.3 mmol/L Standard Deviation 2.10
Changes in Serum Chemistry Values (Sodium, Potassium and Chloride) Between Baseline and Visit 11 Serum sodium change	-0.1 mmol/L Standard Deviation 1.94	-0.2 mmol/L Standard Deviation 1.85

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Outcome measures

Outcome measures
Measure	PQ Grass n=259 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=260 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Serum Chemistry Values (Glucose, Uric Acid, Urea, Phosphorus and Cholesterol) Between Baseline and Visit 11 Serum glucose change	0.065 mmol/L Standard Deviation 0.8844	0.142 mmol/L Standard Deviation 0.9704
Changes in Serum Chemistry Values (Glucose, Uric Acid, Urea, Phosphorus and Cholesterol) Between Baseline and Visit 11 Serum uric acid change	0.005 mmol/L Standard Deviation 0.0427	0.009 mmol/L Standard Deviation 0.0466
Changes in Serum Chemistry Values (Glucose, Uric Acid, Urea, Phosphorus and Cholesterol) Between Baseline and Visit 11 Serum urea change	0.36 mmol/L Standard Deviation 1.1356	0.28 mmol/L Standard Deviation 1.214
Changes in Serum Chemistry Values (Glucose, Uric Acid, Urea, Phosphorus and Cholesterol) Between Baseline and Visit 11 Serum total phosphorus change	0.011 mmol/L Standard Deviation 0.2110	0.027 mmol/L Standard Deviation 0.1926
Changes in Serum Chemistry Values (Glucose, Uric Acid, Urea, Phosphorus and Cholesterol) Between Baseline and Visit 11 Serum total cholesterol change	-0.208 mmol/L Standard Deviation 0.6095	-0.236 mmol/L Standard Deviation 0.6939

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Outcome measures

Outcome measures
Measure	PQ Grass n=257 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=257 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Serum Chemistry Values ( Calcium, Creatinine and Total Bilirubin) Between Baseline and Visit 11 Serum calcium change	-0.039 mmol/L Standard Deviation 0.0868	-0.035 mmol/L Standard Deviation 0.0942
Changes in Serum Chemistry Values ( Calcium, Creatinine and Total Bilirubin) Between Baseline and Visit 11 Serum creatinine change	0.0022 mmol/L Standard Deviation 0.009517	0.0024 mmol/L Standard Deviation 0.00934
Changes in Serum Chemistry Values ( Calcium, Creatinine and Total Bilirubin) Between Baseline and Visit 11 Serum total bilirubin change	0.00029 mmol/L Standard Deviation 0.003945	0.00046 mmol/L Standard Deviation 0.004436

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Outcome measures

Outcome measures
Measure	PQ Grass n=258 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=258 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Serum Chemistry Values (Total Protein and Albumin) Between Baseline and Visit 11 Serum total protein change	-2.0 g/L Standard Deviation 3.57	-2.2 g/L Standard Deviation 3.66
Changes in Serum Chemistry Values (Total Protein and Albumin) Between Baseline and Visit 11 Serum albumin change	-1.2 g/L Standard Deviation 2.46	-1.0 g/L Standard Deviation 2.46

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Outcome measures

Outcome measures
Measure	PQ Grass n=257 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=257 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Serum Chemistry Values (Alkaline Phosphatase, Lactate Dehydrogenase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma-glutamyl Transferase) Between Baseline and Visit 11 Alkaline phosphatase	-2.5 U/L Standard Deviation 10.47	-2.0 U/L Standard Deviation 10.86
Changes in Serum Chemistry Values (Alkaline Phosphatase, Lactate Dehydrogenase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma-glutamyl Transferase) Between Baseline and Visit 11 Lactate dehydrogenase	2.7 U/L Standard Deviation 23.11	4.2 U/L Standard Deviation 26.93
Changes in Serum Chemistry Values (Alkaline Phosphatase, Lactate Dehydrogenase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma-glutamyl Transferase) Between Baseline and Visit 11 Aspartate aminotransferase	0.3 U/L Standard Deviation 15.51	1.3 U/L Standard Deviation 8.78
Changes in Serum Chemistry Values (Alkaline Phosphatase, Lactate Dehydrogenase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma-glutamyl Transferase) Between Baseline and Visit 11 Alanine aminotransferase	-1.8 U/L Standard Deviation 20.73	-0.9 U/L Standard Deviation 17.42
Changes in Serum Chemistry Values (Alkaline Phosphatase, Lactate Dehydrogenase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma-glutamyl Transferase) Between Baseline and Visit 11 Gamma-glutamyl transferase	-0.5 U/L Standard Deviation 18.75	-1.1 U/L Standard Deviation 9.09

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Outcome measures

Outcome measures
Measure	PQ Grass n=257 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=260 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Serum Chemistry Values (C-reactive Protein) Between Baseline and Visit 11	-0.33 mg/L Standard Deviation 3.453	-0.1 mg/L Standard Deviation 3.991

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

The outcome includes total red blood cells number at visit 11 and change from baseline expressed as cells x 10\^12/L

Outcome measures

Outcome measures
Measure	PQ Grass n=254 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=252 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Haematology Values (Red Blood Cells) Between Baseline and Visit 11 Absolute count of red blood cells at visit 11	4.81 number of cells(x10^12)/L Standard Error 0.460	4.84 number of cells(x10^12)/L Standard Error 0.465
Changes in Haematology Values (Red Blood Cells) Between Baseline and Visit 11 Change in number of red blood cells from baseline to visit 11	-0.03 number of cells(x10^12)/L Standard Error 0.2242	-0.03 number of cells(x10^12)/L Standard Error 0.237

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Outcomes include the change from baseline in the number of white blood cells and platelets expressed as cells x 10\^9/L

Outcome measures

Outcome measures
Measure	PQ Grass n=254 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=252 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Hematology Values (White Blood Cells and Platelets) Between Baseline and Visit 11 Change from baseline to visit 11 in the number of white blood cells	-0.21 number of cells(x10^9)/L Standard Deviation 1.762	-0.11 number of cells(x10^9)/L Standard Deviation 1.469
Changes in Hematology Values (White Blood Cells and Platelets) Between Baseline and Visit 11 Change from baseline to visit 11 in the number of platelets	-4.4 number of cells(x10^9)/L Standard Deviation 60.00	-12.5 number of cells(x10^9)/L Standard Deviation 45.22

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Outcome measures

Outcome measures
Measure	PQ Grass n=254 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=252 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Change in Hematology Values (Hemoglobin) Between Baseline and Visit 11	-1.5 g/L Standard Deviation 7.75	-1.4 g/L Standard Deviation 7.34

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41).

Urinalysis was performed using a urine dip-stick - Results were assessed by the investigators as clinical significant or not. The pH is measured in a scale from 0 to 14 (being 0 the most acid and 14 the most basic values)

Outcome measures

Outcome measures
Measure	PQ Grass n=257 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=256 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Clinical Laboratory Values (Urinalysis: pH) Between Baseline and Visit 11	-0.061 units on a scale Standard Deviation 1.0138	0.001 units on a scale Standard Deviation 1.0082

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Urinalysis was determined using a urine dip-stick - Results were scored as zero, traces, +1, +2, +3, +4 (being zero no detection of the parameter, and 4 the maximum value) Note: Microscopic examination was conducted if protein, leukocytes and/or blood are detected. If needed, microscopic examination included white blood cells, red blood cells, casts, and bacteria.

Outcome measures

Outcome measures
Measure	PQ Grass n=279 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=276 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at visit 11 · Traces	6 Participants	5 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at visit 11 · +2	1 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at visit 11 · +3	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at visit 11 · +4	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at screening · 0	277 Participants	274 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at screening · Traces	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at screening · +1	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at screening · +4	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at visit 11 · Traces	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at visit 11 · +1	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at visit 11 · +3	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at visit 11 · +4	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at visit 11 · Missing	20 Participants	18 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at screening · +1	1 Participants	3 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at screening · +2	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at visit 11 · 0	247 Participants	250 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at visit 11 · +4	2 Participants	4 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at visit 11 · Missing	20 Participants	18 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Leukocytes at screening · 0	263 Participants	252 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Leukocytes at screening · Traces	3 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Leukocytes at screening · +1	3 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Leukocytes at screening · +2	3 Participants	3 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Leukocytes at screening · Missing	2 Participants	18 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at visit 11 · +1	3 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at visit 11 · Missing	20 Participants	18 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at screening · +2	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at screening · +3	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at screening · Missing	2 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at visit 11 · 0	259 Participants	258 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Glucose at visit 11 · +2	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at screening · 0	276 Participants	270 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at screening · Traces	0 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at screening · +3	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at screening · +4	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at screening · Missing	2 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at visit 11 · 0	259 Participants	257 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at visit 11 · Traces	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at visit 11 · +1	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at visit 11 · +2	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at visit 11 · +3	0 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at visit 11 · +4	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Bilirubin at visit 11 · Missing	20 Participants	18 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at screening · 0	261 Participants	264 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at screening · Traces	0 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at screening · +1	5 Participants	3 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at screening · +2	4 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at screening · +3	4 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at screening · +4	3 Participants	3 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at screening · Missing	2 Participants	3 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at visit 11 · Traces	3 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at visit 11 · +1	2 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at visit 11 · +2	4 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Blood at visit 11 · +3	1 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Leukocytes at screening · +3	4 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Leukocytes at screening · +4	1 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at screening · 0	264 Participants	257 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at screening · Traces	8 Participants	10 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at screening · +1	5 Participants	7 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at screening · +2	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at screening · +3	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at screening · +4	0 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at screening · Missing	2 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Protein, Glucose, Bilirubin, Blood and Leukocytes) at Baseline and Visit 11 Protein at visit 11 · 0	249 Participants	250 Participants

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Population: One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo. Safety results are based on treatment received. Serum chemistry was not available for all subjects, the number of available data for each analyte is detailed.

Urinalysis was performed using a urine dip-stick - Results were represented as negative or positive Note: Microscopic examination was conducted if nitrite was detected. If needed, microscopic examination included white blood cells, red blood cells, casts, and bacteria.

Outcome measures

Outcome measures
Measure	PQ Grass n=279 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=276 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Urobilinogen at visit 11 · Negative	259 Participants	257 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Urobilinogen at visit 11 · Positive	0 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Urobilinogen at visit 11 · Missing	20 Participants	18 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Ketones at screening · Negative	277 Participants	273 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Ketones at screening · Positive	0 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Ketones at screening · Missing	2 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Ketones at visit 11 · Negative	257 Participants	257 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Ketones at visit 11 · Positive	2 Participants	1 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Ketones at visit 11 · Missing	20 Participants	18 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Nitrite at baseline · Negative	274 Participants	272 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Urobilinogen at screening · Missing	2 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Nitrite at baseline · Positive	3 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Nitrite at baseline · Missing	2 Participants	2 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Nitrite at visit 11 · Negative	257 Participants	258 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Nitrite at visit 11 · Positive	2 Participants	0 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Nitrite at visit 11 · Missing	20 Participants	18 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Urobilinogen at screening · Negative	277 Participants	274 Participants
Clinical Laboratory Values (Urinalysis: Ketones, Nitrite, Urobilinogen ) at Baseline and Visit 11 Urobilinogen at screening · Positive	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Visit 1 (baseline) to visit 11 (week 28-41)

Blood pressure was measured (in millimeters of mercury) at all treatment visits: Visit (V)1, V2 (2-8 weeks), V3 (3-9 weeks), V4 (4-10 weeks), V5 (7-15 weeks), V6 (10-20 weeks), V7 (week 13-25), V8 (16.29 weeks), V9 (18-31 weeks), V10 (23-36 weeks), V11 (28-41 weeks). At Visits 2 to 7, vital sign measurements were performed before and 30 to 60 minutes following investigational drug/placebo administration.

Outcome measures

Outcome measures
Measure	PQ Grass n=279 Participants 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=276 Participants 6 subcutaneous injections of placebo Placebo: Solution for injection
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 2 (post-dose) - Baseline	-1.2 mmHg Standard Deviation 7.93	-1.5 mmHg Standard Deviation 7.97
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 4 (post-dose) - Baseline	-1.1 mmHg Standard Deviation 9.94	-2.1 mmHg Standard Deviation 10.05
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 5 (pre-dose) - Baseline	0.6 mmHg Standard Deviation 10.06	-0.7 mmHg Standard Deviation 10.07
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 5 (post-dose) - Baseline	-1.7 mmHg Standard Deviation 9.28	-2.3 mmHg Standard Deviation 10.45
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 6 (pre-dose) - Baseline	-0.3 mmHg Standard Deviation 10.06	-0.3 mmHg Standard Deviation 10.29
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 11 - Baseline	-1.2 mmHg Standard Deviation 11.07	-2.3 mmHg Standard Deviation 11.11
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 7 (pre-dose) - Baseline	-0.5 mmHg Standard Deviation 8.09	-0.7 mmHg Standard Deviation 8.54
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 7 (post-dose) - Baseline	-0.7 mmHg Standard Deviation 7.77	-1.3 mmHg Standard Deviation 8.52
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 3 (pre-dose) - Baseline	0.4 mmHg Standard Deviation 9.22	0.00 mmHg Standard Deviation 9.32
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 3 (post-dose) - Baseline	-1.8 mmHg Standard Deviation 9.75	-1.4 mmHg Standard Deviation 9.74
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 4 (pre-dose) - Baseline	0.3 mmHg Standard Deviation 10.29	0.4 mmHg Standard Deviation 10.33
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 6 (post-dose) - Baseline	-2.0 mmHg Standard Deviation 10.52	-2.3 mmHg Standard Deviation 10.69
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 7 (pre-dose) - Baseline	-0.7 mmHg Standard Deviation 10.10	-1.9 mmHg Standard Deviation 10.65
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 7 (post-dose) - Baseline	-2.5 mmHg Standard Deviation 10.12	-3.0 mmHg Standard Deviation 10.51
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 8 - Baseline	-1.4 mmHg Standard Deviation 10.04	-1.1 mmHg Standard Deviation 10.40
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 9 - Baseline	-0.5 mmHg Standard Deviation 10.66	-1.9 mmHg Standard Deviation 10.45
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Systolic blood pressure at visit 10 - Baseline	-0.9 mmHg Standard Deviation 11.12	-1.8 mmHg Standard Deviation 10.78
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 2 (post-dose) - Baseline	0.2 mmHg Standard Deviation 5.77	-0.1 mmHg Standard Deviation 6.70
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 3 (pre-dose) - Baseline	-0.2 mmHg Standard Deviation 7.48	-0.4 mmHg Standard Deviation 7.52
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 3 (post-dose) - Baseline	-1.0 mmHg Standard Deviation 7.00	-0.7 mmHg Standard Deviation 8.00
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 4 (pre-dose) - Baseline	0.2 mmHg Standard Deviation 7.43	-0.4 mmHg Standard Deviation 7.67
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 4 (post-dose) - Baseline	-0.7 mmHg Standard Deviation 7.91	-1.1 mmHg Standard Deviation 7.73
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 5 (pre-dose) - Baseline	-0.1 mmHg Standard Deviation 7.93	-0.6 mmHg Standard Deviation 8.05
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 5 (post-dose) - Baseline	-0.3 mmHg Standard Deviation 7.93	-1.3 mmHg Standard Deviation 8.37
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 6 (pre-dose) - Baseline	-0.5 mmHg Standard Deviation 7.68	0.2 mmHg Standard Deviation 7.91
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 6 (post-dose) - Baseline	-0.7 mmHg Standard Deviation 7.76	-1.4 mmHg Standard Deviation 7.91
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 8 - Baseline	-1.4 mmHg Standard Deviation 8.08	-0.9 mmHg Standard Deviation 8.25
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 9 - Baseline	-0.4 mmHg Standard Deviation 8.19	-1.8 mmHg Standard Deviation 7.72
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 10 - Baseline	-0.3 mmHg Standard Deviation 8.12	-0.9 mmHg Standard Deviation 8.56
Changes in Vital Signs (Systolic and Diastolic Blood Pressure) From Baseline to All Treatment Visits Diastolic blood pressure at visit 11 - Baseline	-0.1 mmHg Standard Deviation 8.42	-1.3 mmHg Standard Deviation 8.88

Adverse Events

PQ Grass

Serious events: 5 serious events

Other events: 226 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 155 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PQ Grass n=279 participants at risk 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=276 participants at risk 6 subcutaneous injections of placebo Placebo: Solution for injection
Immune system disorders anaphylactic reaction	0.36% 1/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.00% 0/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Immune system disorders Hypersensitivity	0.00% 0/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.36% 1/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Cardiac disorders Rhythm idioventricular	0.36% 1/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.00% 0/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Cardiac disorders Supraventricular tachycardia	0.36% 1/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.00% 0/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Hepatobiliary disorders Cholelithiasis	0.00% 0/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.36% 1/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Injury, poisoning and procedural complications Head injury	0.36% 1/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.00% 0/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.36% 1/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Nervous system disorders Dizziness	0.36% 1/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.00% 0/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Psychiatric disorders Anxiety	0.36% 1/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.00% 0/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.36% 1/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.00% 0/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received

Other adverse events

Other adverse events
Measure	PQ Grass n=279 participants at risk 6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU PQ Grass: Suspension for Injection	Placebo n=276 participants at risk 6 subcutaneous injections of placebo Placebo: Solution for injection
Nervous system disorders Headache	9.3% 26/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	7.2% 20/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
General disorders Injection site erythema	65.6% 183/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	10.1% 28/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
General disorders Injection site swelling	57.7% 161/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	15.6% 43/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
General disorders Injection site pain	44.1% 123/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	23.6% 65/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
General disorders Injection site pruritus	47.7% 133/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	8.7% 24/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
General disorders Injection site warmth	6.8% 19/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	1.8% 5/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
General disorders Injection site urticaria	5.7% 16/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	0.36% 1/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Eye disorders Eye pruritus	8.2% 23/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	8.3% 23/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Eye disorders Lacrimation increased	5.0% 14/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	3.6% 10/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	12.5% 35/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	9.1% 25/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Respiratory, thoracic and mediastinal disorders Sneezing	12.2% 34/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	9.8% 27/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.5% 21/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	9.4% 26/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Respiratory, thoracic and mediastinal disorders Nasal pruritus	5.7% 16/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	8.3% 23/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received
Infections and infestations Nasopharyngitis	10.0% 28/279 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received	8.0% 22/276 • AE were reported throughout the study from visit 1 (baseline) to the last follow-up call (week 40-46) One subject randomized to placebo received PQ Grass throughout the trial, consequently 279 subjects were treated with PQ Grass and 276 subjects with placebo; results are based on treatment received

Additional Information

Pieter-Jan De Kam, Clinical Director

Allergy Therapeutics (UK) Ltd.

Phone: +44 (0) 1903 844 700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER