Trial Outcomes & Findings for A Dose-finding Study of ASP4070 (NCT NCT03101267)
NCT ID: NCT03101267
Last Updated: 2024-11-26
Results Overview
Participants were assessed for each symptom (sneezing, nasal discharge and nasal congestion) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but does not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interferes with the activities of daily living). 3TNSS was a summed score of each symptom, and mean of 3TNSS at 120 to 180 min is the average of 5 timepoints of 3TNSS score, which ranged from 0 to 12. Higher 3TNSS score indicated greater disease activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)
Results posted on
2024-11-26
Participant Flow
A total of 150 participants with cedar pollinosis were enrolled in this study. Participants were randomly allocated to 3 groups in a ratio of 1:1:1 to ASP4070 4 mg group, ASP4070 1 mg group or placebo group.
"Class of Japanese Red Cedar (JRC) pollen-specific Immunoglobulin E (IgE) antibody test at screening visit 1" and "Change from pre-exposure in mean total 3 nasal symptom (sneezing, nasal discharge and nasal congestion) score 120 to 180 minutes after start of cedar pollen exposure at screening visit 2" were used as stratification.
Participant milestones
| Measure |
ASP4070 4 mg
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Primary Study Period
STARTED
|
50
|
50
|
50
|
|
Primary Study Period
COMPLETED
|
47
|
48
|
47
|
|
Primary Study Period
NOT COMPLETED
|
3
|
2
|
3
|
|
Pollinosis Symptoms Survey Period
STARTED
|
47
|
48
|
47
|
|
Pollinosis Symptoms Survey Period
COMPLETED
|
47
|
48
|
47
|
|
Pollinosis Symptoms Survey Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
ASP4070 4 mg
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Primary Study Period
Withdrawal by Subject
|
1
|
2
|
3
|
|
Primary Study Period
Miscellaneous
|
2
|
0
|
0
|
Baseline Characteristics
Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
Baseline characteristics by cohort
| Measure |
ASP4070 4 mg
n=50 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=50 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=50 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.4 year
STANDARD_DEVIATION 8.6 • n=50 Participants
|
38.1 year
STANDARD_DEVIATION 8.5 • n=50 Participants
|
37.8 year
STANDARD_DEVIATION 9.3 • n=50 Participants
|
38.1 year
STANDARD_DEVIATION 8.8 • n=150 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=50 Participants
|
31 Participants
n=50 Participants
|
26 Participants
n=50 Participants
|
90 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=50 Participants
|
19 Participants
n=50 Participants
|
24 Participants
n=50 Participants
|
60 Participants
n=150 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
150 Participants
n=150 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
Asian
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
150 Participants
n=150 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Class of Japanese Red Cedar (JRC) Specific Immunoglobulin E (IgE) Antibody Test
3
|
26 Participants
n=48 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
26 Participants
n=49 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
26 Participants
n=48 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
78 Participants
n=145 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
|
Class of Japanese Red Cedar (JRC) Specific Immunoglobulin E (IgE) Antibody Test
4
|
16 Participants
n=48 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
15 Participants
n=49 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
17 Participants
n=48 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
48 Participants
n=145 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
|
Class of Japanese Red Cedar (JRC) Specific Immunoglobulin E (IgE) Antibody Test
5
|
3 Participants
n=48 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
6 Participants
n=49 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
4 Participants
n=48 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
13 Participants
n=145 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
|
Class of Japanese Red Cedar (JRC) Specific Immunoglobulin E (IgE) Antibody Test
6
|
3 Participants
n=48 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
2 Participants
n=49 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
1 Participants
n=48 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
6 Participants
n=145 Participants • Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
|
|
Change From Pre-exposure in Mean of Total 3 Nasal Symptom Score During 120 to 180 Minutes
|
4.79 units on a scale
STANDARD_DEVIATION 1.53 • n=48 Participants • FAS
|
4.89 units on a scale
STANDARD_DEVIATION 1.31 • n=49 Participants • FAS
|
4.78 units on a scale
STANDARD_DEVIATION 1.25 • n=48 Participants • FAS
|
4.82 units on a scale
STANDARD_DEVIATION 1.36 • n=145 Participants • FAS
|
PRIMARY outcome
Timeframe: Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)Population: Full Analysis Set (FAS) consisted of all participants who were randomized, vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.
Participants were assessed for each symptom (sneezing, nasal discharge and nasal congestion) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but does not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interferes with the activities of daily living). 3TNSS was a summed score of each symptom, and mean of 3TNSS at 120 to 180 min is the average of 5 timepoints of 3TNSS score, which ranged from 0 to 12. Higher 3TNSS score indicated greater disease activity.
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Mean Total 3 Nasal Symptom Score (3TNSS) 120 to 180 Minutes After Start of Cedar Pollen Exposure on Day 183
|
2.04 units on a scale
Standard Deviation 1.30
|
1.91 units on a scale
Standard Deviation 1.82
|
1.98 units on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for each symptom (sneezing, nasal discharge, nasal congestion and itchy nose) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living). 4TNSS was a summed score of each symptom, and mean of 4TNSS at 120 to 180 min is the average of 5 timepoints of 4TNSS score, which ranged from 0 to 16. Higher 4TNSS score indicated greater disease activity.
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
4.21 units on a scale
Standard Deviation 1.73
|
4.07 units on a scale
Standard Deviation 2.69
|
4.02 units on a scale
Standard Deviation 2.51
|
|
Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
3.46 units on a scale
Standard Deviation 2.09
|
3.20 units on a scale
Standard Deviation 2.73
|
3.32 units on a scale
Standard Deviation 2.00
|
|
Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
2.71 units on a scale
Standard Deviation 1.61
|
2.58 units on a scale
Standard Deviation 2.50
|
2.62 units on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for sneezing using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living)
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
0.57 units on a scale
Standard Deviation 0.57
|
0.47 units on a scale
Standard Deviation 0.53
|
0.49 units on a scale
Standard Deviation 0.52
|
|
Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
0.46 units on a scale
Standard Deviation 0.42
|
0.39 units on a scale
Standard Deviation 0.37
|
0.39 units on a scale
Standard Deviation 0.39
|
|
Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
0.40 units on a scale
Standard Deviation 0.41
|
0.28 units on a scale
Standard Deviation 0.37
|
0.36 units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for nasal discharge using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living)
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
1.54 units on a scale
Standard Deviation 0.62
|
1.30 units on a scale
Standard Deviation 0.93
|
1.42 units on a scale
Standard Deviation 0.82
|
|
Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
1.29 units on a scale
Standard Deviation 0.69
|
1.12 units on a scale
Standard Deviation 0.91
|
1.27 units on a scale
Standard Deviation 0.80
|
|
Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
0.96 units on a scale
Standard Deviation 0.65
|
0.93 units on a scale
Standard Deviation 0.86
|
0.87 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for nasal congestion using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living)
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
1.14 units on a scale
Standard Deviation 0.70
|
1.26 units on a scale
Standard Deviation 0.89
|
1.18 units on a scale
Standard Deviation 0.92
|
|
Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
0.91 units on a scale
Standard Deviation 0.68
|
0.90 units on a scale
Standard Deviation 0.89
|
0.92 units on a scale
Standard Deviation 0.77
|
|
Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
0.68 units on a scale
Standard Deviation 0.62
|
0.70 units on a scale
Standard Deviation 0.78
|
0.75 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for itchy nose using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living)
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
0.97 units on a scale
Standard Deviation 0.64
|
1.03 units on a scale
Standard Deviation 0.88
|
0.93 units on a scale
Standard Deviation 0.89
|
|
Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
0.80 units on a scale
Standard Deviation 0.75
|
0.79 units on a scale
Standard Deviation 0.91
|
0.74 units on a scale
Standard Deviation 0.80
|
|
Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
0.68 units on a scale
Standard Deviation 0.56
|
0.67 units on a scale
Standard Deviation 0.80
|
0.63 units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for each non-nasal symptom (itchy eyes and watery eyes) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living). TNNSS was a summed score of each symptom, and mean of TNNSS at 120 to 180 min is the average of 5 timepoints of TNNSS score, which ranged from 0 to 8. Higher TNNSS score indicated greater disease activity.
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
0.83 units on a scale
Standard Deviation 1.22
|
0.96 units on a scale
Standard Deviation 1.17
|
0.61 units on a scale
Standard Deviation 0.93
|
|
Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
0.62 units on a scale
Standard Deviation 1.10
|
0.83 units on a scale
Standard Deviation 1.40
|
0.50 units on a scale
Standard Deviation 0.71
|
|
Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
0.59 units on a scale
Standard Deviation 1.09
|
0.73 units on a scale
Standard Deviation 1.19
|
0.40 units on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for itchy eyes using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living)
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
0.51 units on a scale
Standard Deviation 0.75
|
0.58 units on a scale
Standard Deviation 0.72
|
0.44 units on a scale
Standard Deviation 0.66
|
|
Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
0.36 units on a scale
Standard Deviation 0.63
|
0.49 units on a scale
Standard Deviation 0.80
|
0.33 units on a scale
Standard Deviation 0.50
|
|
Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
0.35 units on a scale
Standard Deviation 0.67
|
0.43 units on a scale
Standard Deviation 0.69
|
0.29 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for watery eyes using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living)
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
0.32 units on a scale
Standard Deviation 0.57
|
0.38 units on a scale
Standard Deviation 0.57
|
0.17 units on a scale
Standard Deviation 0.38
|
|
Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
0.26 units on a scale
Standard Deviation 0.55
|
0.34 units on a scale
Standard Deviation 0.67
|
0.17 units on a scale
Standard Deviation 0.37
|
|
Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
0.24 units on a scale
Standard Deviation 0.48
|
0.30 units on a scale
Standard Deviation 0.57
|
0.11 units on a scale
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for each 5TSS (sneezing, nasal discharge, nasal congestion, itchy eyes and watery eyes) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living). 5TSS was a summed score of each symptom, and mean of 5TSS at 120 to 180 min is the average of 5 timepoints of 5TSS score, which ranged from 0 to 20. Higher 5TSS score indicated greater disease activity.
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
4.08 units on a scale
Standard Deviation 1.95
|
3.99 units on a scale
Standard Deviation 2.67
|
3.70 units on a scale
Standard Deviation 2.40
|
|
Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
3.28 units on a scale
Standard Deviation 2.07
|
3.24 units on a scale
Standard Deviation 2.98
|
3.07 units on a scale
Standard Deviation 1.84
|
|
Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
2.63 units on a scale
Standard Deviation 1.82
|
2.64 units on a scale
Standard Deviation 2.62
|
2.38 units on a scale
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183Population: FAS
Participants were assessed for each 6TSS (sneezing, nasal discharge, nasal congestion, itchy nose, itchy eyes and watery eyes) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interfered with the activities of daily living). 6TSS was a summed score of each symptom, and mean of 6TSS at 120 to 180 min is the average of 5 timepoints of 6TSS score, which ranged from 0 to 24. Higher 6TSS score indicated greater disease activity.
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 127
|
5.04 units on a scale
Standard Deviation 2.39
|
5.02 units on a scale
Standard Deviation 3.31
|
4.63 units on a scale
Standard Deviation 3.09
|
|
Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 155
|
4.08 units on a scale
Standard Deviation 2.66
|
4.03 units on a scale
Standard Deviation 3.74
|
3.82 units on a scale
Standard Deviation 2.30
|
|
Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure
Day 183
|
3.30 units on a scale
Standard Deviation 2.19
|
3.31 units on a scale
Standard Deviation 3.29
|
3.02 units on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Days 127, 155 and 183, from the start of cedar pollen exposure for up to 180 minutesPopulation: FAS
Time point when the score of nasal or eye symptom worsens by 1 or more as compared to before cedar pollen exposure were assessed.
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure
Day 127
|
15.0 minutes
Interval 15.0 to 30.0
|
15.0 minutes
Interval 15.0 to 30.0
|
30.0 minutes
Interval 15.0 to 30.0
|
|
Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure
Day 155
|
22.5 minutes
Interval 15.0 to 30.0
|
30.0 minutes
Interval 15.0 to 30.0
|
15.0 minutes
Interval 15.0 to 30.0
|
|
Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure
Day 183
|
30.0 minutes
95% Confidential Interval (CI) was not technically defined due to insufficient number of participants with events around the percentile.
|
30.0 minutes
Interval 15.0 to 45.0
|
30.0 minutes
95% Confidential Interval (CI) was not technically defined due to insufficient number of participants with events around the percentile.
|
SECONDARY outcome
Timeframe: Day 127: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 155: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 183: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 minPopulation: FAS
Nasal discharge amount was calculated by the difference in the weight of the tissue paper before and after use by participants who were instructed to use pre-allocated tissues for blowing their nose.
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 127: 0-30 min
|
0.57 gram
Standard Deviation 0.90
|
0.80 gram
Standard Deviation 1.31
|
0.68 gram
Standard Deviation 1.11
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 127: 30-60 min
|
1.21 gram
Standard Deviation 1.06
|
1.35 gram
Standard Deviation 1.74
|
1.43 gram
Standard Deviation 1.58
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 127: 60-90 min
|
1.58 gram
Standard Deviation 1.41
|
1.61 gram
Standard Deviation 1.91
|
1.73 gram
Standard Deviation 1.88
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 127: 90-120 min
|
1.72 gram
Standard Deviation 1.53
|
1.43 gram
Standard Deviation 1.76
|
1.67 gram
Standard Deviation 2.24
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 127: 120-150 min
|
1.49 gram
Standard Deviation 1.28
|
1.59 gram
Standard Deviation 1.96
|
1.67 gram
Standard Deviation 1.89
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 127: 150-180 min
|
1.64 gram
Standard Deviation 1.42
|
1.56 gram
Standard Deviation 1.77
|
1.61 gram
Standard Deviation 1.79
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 155: 0-30 min
|
0.55 gram
Standard Deviation 1.88
|
0.79 gram
Standard Deviation 1.66
|
0.91 gram
Standard Deviation 1.52
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 155: 30-60 min
|
1.12 gram
Standard Deviation 1.31
|
1.23 gram
Standard Deviation 1.72
|
1.57 gram
Standard Deviation 1.64
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 155: 60-90 min
|
1.25 gram
Standard Deviation 1.46
|
1.45 gram
Standard Deviation 2.08
|
1.75 gram
Standard Deviation 1.84
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 155: 90-120 min
|
1.42 gram
Standard Deviation 1.79
|
1.62 gram
Standard Deviation 2.24
|
1.71 gram
Standard Deviation 1.89
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 155: 120-150 min
|
1.45 gram
Standard Deviation 1.57
|
1.82 gram
Standard Deviation 2.59
|
1.83 gram
Standard Deviation 2.00
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 155: 150-180 min
|
1.63 gram
Standard Deviation 1.69
|
1.91 gram
Standard Deviation 2.56
|
1.70 gram
Standard Deviation 2.00
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 183: 0-30 min
|
0.35 gram
Standard Deviation 0.92
|
0.44 gram
Standard Deviation 0.89
|
0.49 gram
Standard Deviation 1.16
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 183: 30-60 min
|
0.57 gram
Standard Deviation 1.00
|
0.73 gram
Standard Deviation 1.08
|
0.90 gram
Standard Deviation 1.39
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 183: 60-90 min
|
0.71 gram
Standard Deviation 0.94
|
1.20 gram
Standard Deviation 1.93
|
0.84 gram
Standard Deviation 0.98
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 183: 90-120 min
|
0.94 gram
Standard Deviation 1.23
|
1.23 gram
Standard Deviation 2.02
|
0.90 gram
Standard Deviation 1.02
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 183: 120-150 min
|
1.13 gram
Standard Deviation 1.52
|
1.42 gram
Standard Deviation 2.18
|
1.05 gram
Standard Deviation 1.18
|
|
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Day 183: 150-180 min
|
1.06 gram
Standard Deviation 1.35
|
1.54 gram
Standard Deviation 2.07
|
1.23 gram
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Day 127: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 155: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 183: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 minPopulation: FAS
Sneezing count per 30 minutes were measured during chamber exposure.
Outcome measures
| Measure |
ASP4070 4 mg
n=48 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=49 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=48 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 155: 90-120 min
|
1.0 sneezes
Standard Deviation 1.8
|
1.1 sneezes
Standard Deviation 1.9
|
1.0 sneezes
Standard Deviation 1.3
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 155: 120-150 min
|
1.1 sneezes
Standard Deviation 1.3
|
1.0 sneezes
Standard Deviation 1.3
|
1.3 sneezes
Standard Deviation 1.5
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 127: 0-30 min
|
0.4 sneezes
Standard Deviation 0.7
|
0.8 sneezes
Standard Deviation 0.9
|
1.1 sneezes
Standard Deviation 2.1
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 127: 30-60 min
|
1.0 sneezes
Standard Deviation 1.2
|
1.0 sneezes
Standard Deviation 1.5
|
1.3 sneezes
Standard Deviation 2.8
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 127: 60-90 min
|
1.4 sneezes
Standard Deviation 2.0
|
1.5 sneezes
Standard Deviation 2.0
|
1.3 sneezes
Standard Deviation 1.6
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 127: 90-120 min
|
1.4 sneezes
Standard Deviation 1.9
|
1.2 sneezes
Standard Deviation 2.4
|
1.7 sneezes
Standard Deviation 2.5
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 127: 120-150 min
|
1.5 sneezes
Standard Deviation 2.6
|
1.4 sneezes
Standard Deviation 2.1
|
1.3 sneezes
Standard Deviation 2.2
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 127: 150-180 min
|
1.6 sneezes
Standard Deviation 2.1
|
1.2 sneezes
Standard Deviation 1.7
|
1.5 sneezes
Standard Deviation 2.1
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 155: 0-30 min
|
0.8 sneezes
Standard Deviation 1.1
|
0.6 sneezes
Standard Deviation 0.8
|
0.8 sneezes
Standard Deviation 1.4
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 155: 30-60 min
|
0.9 sneezes
Standard Deviation 1.2
|
1.0 sneezes
Standard Deviation 1.4
|
1.1 sneezes
Standard Deviation 2.5
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 155: 60-90 min
|
1.0 sneezes
Standard Deviation 1.1
|
1.1 sneezes
Standard Deviation 1.4
|
1.1 sneezes
Standard Deviation 1.6
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 155: 150-180 min
|
1.4 sneezes
Standard Deviation 2.0
|
1.0 sneezes
Standard Deviation 1.4
|
1.0 sneezes
Standard Deviation 1.7
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 183: 0-30 min
|
0.6 sneezes
Standard Deviation 1.0
|
0.6 sneezes
Standard Deviation 1.0
|
0.5 sneezes
Standard Deviation 0.8
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 183: 30-60 min
|
0.7 sneezes
Standard Deviation 1.3
|
0.4 sneezes
Standard Deviation 0.8
|
0.6 sneezes
Standard Deviation 0.9
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 183: 60-90 min
|
0.8 sneezes
Standard Deviation 0.9
|
0.7 sneezes
Standard Deviation 1.0
|
0.9 sneezes
Standard Deviation 1.5
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 183: 90-120 min
|
1.0 sneezes
Standard Deviation 1.3
|
0.7 sneezes
Standard Deviation 1.1
|
0.9 sneezes
Standard Deviation 1.3
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 183: 120-150 min
|
1.1 sneezes
Standard Deviation 1.5
|
0.7 sneezes
Standard Deviation 1.0
|
1.1 sneezes
Standard Deviation 1.5
|
|
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Day 183: 150-180 min
|
0.9 sneezes
Standard Deviation 1.4
|
0.8 sneezes
Standard Deviation 1.3
|
1.0 sneezes
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: From first dose of study drug up to the end of primary study period (up to 7 days after Day 183)Population: SAF
Treatment emergent adverse events (TEAE) was defined as an AE observed after starting administration of the test drug/comparative drug. A drug-related TEAE was a TEAE with either possible or probable relationship to the study drug as assessed by the investigator. Severity of AEs was assessed according to the following 4 levels. Mild: no disruption of normal daily activities, Moderate: affect normal daily activities, Severe: inability to perform daily activities, Life-threatening: necessity for urgent intervention. If the investigator or subinvestigator examined the patient and determined that the following items occurred from the date of study drug vaccination until 14 days after vaccination and a relationship with the study drug could not be negated, then it was evaluated as a local/systemic reaction at the vaccination site. * Local reactions: pain, tenderness, erythema/redness and induration/swelling * Systemic reactions: nausea/vomiting, diarrhea, headache, fatigue and myalgia
Outcome measures
| Measure |
ASP4070 4 mg
n=50 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=50 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=50 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
TEAE
|
49 Participants
|
44 Participants
|
28 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Mild
|
33 Participants
|
33 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Moderate
|
13 Participants
|
11 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Severe
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Life-threatening Possibility
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Drug-related TEAE
|
45 Participants
|
37 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Device-Related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Serious TEAE
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Drug-related serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
TEAE leading to withdrawal of treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Drug-related TEAE leading to withdrawal of treat.
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Local reaction
|
34 Participants
|
24 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Systemic reaction
|
13 Participants
|
13 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
TEAEs other than local or systemic reactions
|
48 Participants
|
40 Participants
|
21 Participants
|
|
Number of Participants With Adverse Events (AE) During the Primary Study Period
Drug-related TEAEs other than local or systemic
|
38 Participants
|
31 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 9 months after the end of primary study period (primary study period was up to 7 days after Day 183)Population: SAF
If SAEs occurred, then the participant was to contact the study site. With regard to participants who had discontinued the study during the primary study period, if the study drug had been vaccinated even once, then safety information (SAEs) was collected for 1 year after the final vaccination.
Outcome measures
| Measure |
ASP4070 4 mg
n=50 Participants
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=50 Participants
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=50 Participants
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE) During the Long-Term Safety Follow-Up Period
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
ASP4070 4 mg
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
ASP4070 1 mg
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ASP4070 4 mg
n=50 participants at risk
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=50 participants at risk
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=50 participants at risk
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Infections and infestations
Appendiceal abscess
|
2.0%
1/50 • Number of events 1 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
0.00%
0/50 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
0.00%
0/50 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
Infections and infestations
Appendicitis
|
2.0%
1/50 • Number of events 1 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
0.00%
0/50 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
0.00%
0/50 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
Other adverse events
| Measure |
ASP4070 4 mg
n=50 participants at risk
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
|
ASP4070 1 mg
n=50 participants at risk
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
|
Placebo
n=50 participants at risk
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
5/50 • Number of events 6 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
8.0%
4/50 • Number of events 4 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
2.0%
1/50 • Number of events 1 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50 • Number of events 3 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
2.0%
1/50 • Number of events 1 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
4.0%
2/50 • Number of events 2 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
General disorders
Fatigue
|
10.0%
5/50 • Number of events 13 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
12.0%
6/50 • Number of events 19 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
14.0%
7/50 • Number of events 8 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
General disorders
Induration
|
16.0%
8/50 • Number of events 24 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
4.0%
2/50 • Number of events 6 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
0.00%
0/50 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
General disorders
Pain
|
22.0%
11/50 • Number of events 32 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
10.0%
5/50 • Number of events 10 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
2.0%
1/50 • Number of events 1 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
General disorders
Swelling
|
16.0%
8/50 • Number of events 14 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
2.0%
1/50 • Number of events 2 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
0.00%
0/50 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
General disorders
Tenderness
|
46.0%
23/50 • Number of events 71 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
26.0%
13/50 • Number of events 62 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
10.0%
5/50 • Number of events 6 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
General disorders
Vaccination site pruritus
|
74.0%
37/50 • Number of events 179 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
58.0%
29/50 • Number of events 134 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
0.00%
0/50 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
Infections and infestations
Nasopharyngitis
|
36.0%
18/50 • Number of events 19 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
22.0%
11/50 • Number of events 12 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
18.0%
9/50 • Number of events 13 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
3/50 • Number of events 3 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
8.0%
4/50 • Number of events 4 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
8.0%
4/50 • Number of events 4 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
Nervous system disorders
Headache
|
16.0%
8/50 • Number of events 13 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
28.0%
14/50 • Number of events 27 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
8.0%
4/50 • Number of events 5 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/50 • Number of events 1 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
10.0%
5/50 • Number of events 5 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
4.0%
2/50 • Number of events 2 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
62.0%
31/50 • Number of events 146 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
30.0%
15/50 • Number of events 43 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
4.0%
2/50 • Number of events 7 • From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
SAF consisted of all participants who were vaccinated with the study drug at least once.
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Inc.
Phone: +81-3-3244-6500 Japanese only
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER