Trial Outcomes & Findings for An Exploratory Study of PQ Grass 27600 SU (NCT NCT04687059)

119 subjects were randomized (from 7 centers in Germany and 8 centers in the US). First subject was enrolled on October 19, 2020 and the last subject last visit was on October 28, 2021.

A total of 196 subjects were screened and 119 subjects were randomised

An Exploratory Study of PQ Grass 27600 SU

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Number of participants who prematurely discontinued from treatment or study due to AEs.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.