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| Name | Class |
|---|---|
| Immunomic Therapeutics, Inc. | INDUSTRY |
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The objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis.
Subjects were vaccinated with ASP4070 or placebo at 2 week intervals. Clinical symptoms were evaluated after cedar pollen exposure in a chamber at 4, 8 and 12 weeks after the last vaccination to identify the timing of the onset of therapeutic effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP4070 4 mg | Experimental | Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals. |
|
| ASP4070 1 mg | Experimental | Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals. |
|
| Placebo | Placebo Comparator | Participants received Placebo 8 times by intradermal vaccination at 14-day intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP4070 | Drug | Intradermal vaccination at 2-week intervals |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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)
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. | Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure | 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)
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00001 | Shinjuku | Tokyo | Japan |
Not provided
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
Not provided
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
"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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ASP4070 4 mg | Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals. |
| FG001 | ASP4070 1 mg | Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals. |
| FG002 | Placebo | Participants received Placebo 8 times by intradermal vaccination at 14-day intervals. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Study Period |
|
| |||||||||||||||||||||
| Pollinosis Symptoms Survey Period |
|
Safety Analysis Set (SAF) consisted of all participants who were vaccinated with the study drug at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | ASP4070 4 mg | Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals. |
| BG001 | ASP4070 1 mg | Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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)
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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart) |
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ASP4070 4 mg | Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendiceal abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Astellas Pharma Inc. | +81-3-3244-6500 Japanese only | astellas.resultsdisclosure@astellas.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2018 | May 6, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2018 | May 6, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Intradermal vaccination at 2-week intervals |
|
| Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure | 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)
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. | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure | 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)
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. | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure | 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)
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. | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
| Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure | Time point when the score of nasal or eye symptom worsens by 1 or more as compared to before cedar pollen exposure were assessed. | Days 127, 155 and 183, from the start of cedar pollen exposure for up to 180 minutes |
| Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure | 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. | 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 min |
| Sneezing Count Per 30 Minutes During Cedar Pollen Exposure | Sneezing count per 30 minutes were measured during chamber exposure. | 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 min |
| Number of Participants With Adverse Events (AE) During the Primary Study Period | 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.
| From first dose of study drug up to the end of primary study period (up to 7 days after Day 183) |
| Number of Participants With Serious Adverse Events (SAE) During the Long-Term Safety Follow-Up Period | 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. | Up to 9 months after the end of primary study period (primary study period was up to 7 days after Day 183) |
| NOT COMPLETED |
|
| BG002 | Placebo | Participants received Placebo 8 times by intradermal vaccination at 14-day intervals. |
| BG003 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Class of Japanese Red Cedar (JRC) Specific Immunoglobulin E (IgE) Antibody Test | JRC specific IgE antibody test at screening visit 1 was showed. JRC specific IgE antibody was classified from Class 1 to Class 6. Participants with Class 1 and 2 was excluded in the enrollment. | 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. | Count of Participants | Participants |
|
| Change From Pre-exposure in Mean of Total 3 Nasal Symptom Score During 120 to 180 Minutes | At screening visit 2, participants were assessed for each symptom (sneezing, nasal discharge and nasal congestion) using the score from 0 (None; no symptoms) to 4 (Very severe) every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. 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. | FAS | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | ASP4070 4 mg | Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals. |
| OG001 | ASP4070 1 mg | Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals. |
| OG002 | Placebo | Participants received Placebo 8 times by intradermal vaccination at 14-day intervals. |
|
|
|
| Secondary | Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure | 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)
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. | FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure | 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)
| FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure | 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)
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. | FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure | 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)
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. | FAS | Posted | Mean | Standard Deviation | units on a scale | Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183 |
|
|
|
|
| Secondary | Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure | Time point when the score of nasal or eye symptom worsens by 1 or more as compared to before cedar pollen exposure were assessed. | FAS | Posted | Median | 95% Confidence Interval | minutes | Days 127, 155 and 183, from the start of cedar pollen exposure for up to 180 minutes |
|
|
|
| Secondary | Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure | 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. | FAS | Posted | Mean | Standard Deviation | gram | 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 min |
|
|
|
| Secondary | Sneezing Count Per 30 Minutes During Cedar Pollen Exposure | Sneezing count per 30 minutes were measured during chamber exposure. | FAS | Posted | Mean | Standard Deviation | sneezes | 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 min |
|
|
|
| Secondary | Number of Participants With Adverse Events (AE) During the Primary Study Period | 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.
| SAF | Posted | Count of Participants | Participants | From first dose of study drug up to the end of primary study period (up to 7 days after Day 183) |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events (SAE) During the Long-Term Safety Follow-Up Period | 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. | SAF | Posted | Count of Participants | Participants | Up to 9 months after the end of primary study period (primary study period was up to 7 days after Day 183) |
|
|
|
| 0 |
| 50 |
| 2 |
| 50 |
| 47 |
| 50 |
| EG001 | ASP4070 1 mg | Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals. | 0 | 50 | 0 | 50 | 41 | 50 |
| EG002 | Placebo | Participants received Placebo 8 times by intradermal vaccination at 14-day intervals. | 0 | 50 | 0 | 50 | 23 | 50 |
| Appendicitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Induration | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vaccination site pruritus | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
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.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 4 |
|
| 5 |
|
| 6 |
|
| Day 155 |
|
|
| Day 183 |
|
|
4TNSS treatment comparison at day 127 |
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.872 |
| Adjusted mean difference |
| 0.07 |
| 2-Sided |
| 95 |
| -0.84 |
| 0.99 |
| Superiority |
| 4TNSS treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.701 | Adjusted mean difference | 0.18 | 2-Sided | 95 | -0.73 | 1.08 | Superiority |
| 4TNSS treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.925 | Adjusted mean difference | -0.04 | 95 | -0.95 | 0.86 | Superiority |
| 4TNSS treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.690 | Adjusted mean difference | 0.16 | 2-Sided | 95 | -0.64 | 0.97 | Superiority |
| 4TNSS treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.868 | Adjusted mean difference | 0.07 | 2-Sided | 95 | -0.73 | 0.87 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
Sneezing score treatment comparison at day 127 |
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.879 |
| Adjusted mean difference |
| -0.02 |
| 2-Sided |
| 95 |
| -0.23 |
| 0.20 |
| Superiority |
| Sneezing score treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.444 | Adjusted mean difference | 0.06 | 2-Sided | 95 | -0.10 | 0.22 | Superiority |
| Sneezing score treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.987 | Adjusted mean difference | 0.00 | 2-Sided | 95 | -0.16 | 0.16 | Superiority |
| Sneezing score treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.645 | Adjusted mean difference | 0.03 | 2-Sided | 95 | -0.12 | 0.18 | Superiority |
| Sneezing score treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.357 | Adjusted mean difference | -0.07 | 2-Sided | 95 | -0.22 | 0.08 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
Nasal discharge score treatment comparison at day 127 |
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.497 |
| Adjusted mean difference |
| -0.11 |
| 2-Sided |
| 95 |
| -0.43 |
| 0.21 |
| Superiority |
| Nasal discharge score treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.821 | Adjusted mean difference | 0.04 | 2-Sided | 95 | -0.28 | 0.36 | Superiority |
| Nasal discharge score treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.414 | Adjusted mean difference | -0.13 | 2-Sided | 95 | -0.45 | 0.19 | Superiority |
| Nasal discharge score treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.414 | Adjusted mean difference | 0.12 | 2-Sided | 95 | -0.17 | 0.41 | Superiority |
| Nasal discharge score treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.566 | Adjusted mean difference | 0.08 | 2-Sided | 95 | -0.20 | 0.37 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
Nasal congestion score treatment comparison at day 127
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.587 |
| Adjusted mean difference |
| 0.09 |
| 2-Sided |
| 95 |
| -0.24 |
| 0.42 |
| Superiority |
| Nasal congestion score treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.975 | Adjusted mean difference | 0.00 | 2-Sided | 95 | -0.30 | 0.31 | Superiority |
| Nasal congestion score treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.980 | Adjusted mean difference | 0.00 | 2-Sided | 95 | -0.31 | 0.31 | Superiority |
| Nasal congestion score treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.621 | Adjusted mean difference | -0.07 | 2-Sided | 95 | -0.35 | 0.21 | Superiority |
| Nasal congestion score treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.831 | Adjusted mean difference | -0.03 | 2-Sided | 95 | -0.31 | 0.25 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
Itchy nose score treatment comparison at day 127 |
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.502 |
| Adjusted mean difference |
| 0.11 |
| 2-Sided |
| 95 |
| -0.21 |
| 0.43 |
| Superiority |
| Itchy nose score treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.652 | Adjusted mean difference | 0.07 | 2-Sided | 95 | -0.25 | 0.40 | Superiority |
| Itchy nose score treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.633 | Adjusted mean difference | 0.08 | 2-Sided | 95 | -0.25 | 0.41 | Superiority |
| Itchy nose score treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.596 | Adjusted mean difference | 0.07 | 2-Sided | 95 | -0.20 | 0.35 | Superiority |
| Itchy nose score treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.621 | Adjusted mean difference | 0.07 | 2-Sided | 95 | -0.21 | 0.34 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
TNNSS treatment comparison at day 127 |
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.102 |
| Adjusted mean difference |
| 0.36 |
| 2-Sided |
| 95 |
| -0.07 |
| 0.80 |
| Superiority |
| TNNSS treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.625 | Adjusted mean difference | 0.11 | 2-Sided | 95 | -0.34 | 0.56 | Superiority |
| TNNSS treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.145 | Adjusted mean difference | 0.33 | 2-Sided | 95 | -0.12 | 0.78 | Superiority |
| TNNSS treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.364 | Adjusted mean difference | 0.19 | 2-Sided | 95 | -0.22 | 0.59 | Superiority |
| TNNSS treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.082 | Adjusted mean difference | 0.35 | 2-Sided | 95 | -0.05 | 0.76 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
Itchy eyes treatment comparison at day 127 |
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.288 |
| Adjusted mean difference |
| 0.15 |
| 2-Sided |
| 95 |
| -0.13 |
| 0.43 |
| Superiority |
| Itchy eyes treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.830 | Adjusted mean difference | 0.03 | 2-Sided | 95 | -0.24 | 0.30 | Superiority |
| Itchy eyes treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.208 | Adjusted mean difference | 0.17 | 2-Sided | 95 | -0.10 | 0.44 | Superiority |
| Itchy eyes treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.616 | Adjusted mean difference | 0.06 | 2-Sided | 95 | -0.19 | 0.31 | Superiority |
| Itchy eyes treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.207 | Adjusted mean difference | 0.16 | 2-Sided | 95 | -0.09 | 0.41 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
Watery eyes treatment comparison at day 127 |
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.039 |
| Adjusted mean difference |
| 0.21 |
| 2-Sided |
| 95 |
| 0.01 |
| 0.41 |
| Superiority |
| Watery eyes treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.459 | Adjusted mean difference | 0.08 | 2-Sided | 95 | -0.14 | 0.30 | Superiority |
| Watery eyes treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.153 | Adjusted mean difference | 0.16 | 2-Sided | 95 | -0.06 | 0.38 | Superiority |
| Watery eyes treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.195 | Adjusted mean difference | 0.12 | 2-Sided | 95 | -0.06 | 0.31 | Superiority |
| Watery eyes treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.038 | Adjusted mean difference | 0.20 | 2-Sided | 95 | 0.01 | 0.38 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
5TSS treatment comparison at day 127 |
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.479 |
| Adjusted mean difference |
| 0.33 |
| 2-Sided |
| 95 |
| -0.59 |
| 1.24 |
| Superiority |
| 5TSS treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.648 | Adjusted mean difference | 0.22 | 2-Sided | 95 | -0.71 | 1.14 | Superiority |
| 5TSS treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.654 | Adjusted mean difference | 0.21 | 2-Sided | 95 | -0.72 | 1.14 | Superiority |
| 5TSS treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.514 | Adjusted mean difference | 0.27 | 2-Sided | 95 | -0.55 | 1.09 | Superiority |
| 5TSS treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.400 | Adjusted mean difference | 0.35 | 2-Sided | 95 | -0.47 | 1.17 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
6TSS treatment comparison at day 127 |
| MMRM |
The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. |
| 0.451 |
| Adjusted mean difference, |
| 0.44 |
| 2-Sided |
| 95 |
| -0.71 |
| 1.58 |
| Superiority |
| 6TSS treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.623 | Adjusted mean difference, | 0.29 | 2-Sided | 95 | -0.88 | 1.46 | Superiority |
| 6TSS treatment comparison at day 155 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.620 | Adjusted mean difference, | 0.29 | 2-Sided | 95 | -0.87 | 1.46 | Superiority |
| 6TSS treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.504 | Adjusted mean difference, | 0.35 | 2-Sided | 95 | -0.68 | 1.37 | Superiority |
| 6TSS treatment comparison at day 183 | MMRM | The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit. | 0.414 | Adjusted mean difference, | 0.42 | 2-Sided | 95 | -0.60 | 1.45 | Superiority |
| Day 155 |
|
|
| Day 183 |
|
|
| Day 127: 30-60 min |
|
|
| Day 127: 60-90 min |
|
|
| Day 127: 90-120 min |
|
|
| Day 127: 120-150 min |
|
|
| Day 127: 150-180 min |
|
|
| Day 155: 0-30 min |
|
|
| Day 155: 30-60 min |
|
|
| Day 155: 60-90 min |
|
|
| Day 155: 90-120 min |
|
|
| Day 155: 120-150 min |
|
|
| Day 155: 150-180 min |
|
|
| Day 183: 0-30 min |
|
|
| Day 183: 30-60 min |
|
|
| Day 183: 60-90 min |
|
|
| Day 183: 90-120 min |
|
|
| Day 183: 120-150 min |
|
|
| Day 183: 150-180 min |
|
|
| Day 127: 30-60 min |
|
|
| Day 127: 60-90 min |
|
|
| Day 127: 90-120 min |
|
|
| Day 127: 120-150 min |
|
|
| Day 127: 150-180 min |
|
|
| Day 155: 0-30 min |
|
|
| Day 155: 30-60 min |
|
|
| Day 155: 60-90 min |
|
|
| Day 155: 90-120 min |
|
|
| Day 155: 120-150 min |
|
|
| Day 155: 150-180 min |
|
|
| Day 183: 0-30 min |
|
|
| Day 183: 30-60 min |
|
|
| Day 183: 60-90 min |
|
|
| Day 183: 90-120 min |
|
|
| Day 183: 120-150 min |
|
|
| Day 183: 150-180 min |
|
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Life-threatening Possibility |
|
| Drug-related TEAE |
|
| Device-Related TEAE |
|
| Serious TEAE |
|
| Drug-related serious TEAE |
|
| TEAE leading to withdrawal of treatment |
|
| Drug-related TEAE leading to withdrawal of treat. |
|
| Death |
|
| Local reaction |
|
| Systemic reaction |
|
| TEAEs other than local or systemic reactions |
|
| Drug-related TEAEs other than local or systemic |
|