Back to resultsA Dose-finding Study of ASP4070
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ASP4070
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Cedar pollinosis, ASP4070, DNA plasmid vaccine
Eligibility Criteria
Inclusion Criteria:
- Subject who has exhibited symptoms of cedar pollinosis, consisting of nasal symptoms (sneezing, nasal discharge or nasal obstruction) and eye symptoms (itchy eyes or watery eyes) during the pollen dispersal seasons in 2016 and 2017
- Subject who is positive for the Japanese red cedar (JRC) pollen-specific serum IgE antibody test
- At screening, subject whose score has worsened compared to baseline over 120 to 180 minutes after cedar pollen exposure in a chamber
Exclusion Criteria:
- Subject who has positive the test result of serum IgE antibody specific to other antigen than JRC pollen at screening
- Subject who has received specific immunotherapy (including desensitization therapy) for cedar pollinosis in the past
- Subject who has received specific or non-specific immunotherapy within 5 years prior to screening
- Subject who has received laser therapy or surgery for the treatment of nasal symptoms within 3 years prior to screening.
- Subject who has a history of allergic reactions such as anaphylactic shock and exanthema generalized caused by food and/or medical products in the past
- Subject who has a positive test result for hepatitis B surface (HBs) antigen or anti-hepatitis C virus (HCV) antibody
- Subject who has nasal disease that may interfere with the evaluation
- Subject who has autoimmune disease or other serious primary disease
- Subject who was diagnosed with immunodeficiency in the past
- Subject who has a complication of seasonal allergic rhinitis (due to allergens other than Japanese cedars or cypress), perennial allergic rhinitis, rhinitis medicamentosa, or non-allergic rhinitis that requires medical treatment
- Subject who has a complication of cardiovascular disease
- Subject who has a complication of hepatic disease
- Subject who has a complication of renal disease
- Subject who has a complication of respiratory disease
- Subject has a complication of malignant tumor or has been diagnosed with or has received treatment for malignant tumor within 5 years prior to the first vaccination of the study drug
- Subject who was diagnosed with schizophrenia, other mental conditions
- Subject who has a complication that may have an impact on the results of the local or systemic reaction
- Subject who has received a vaccination of Cry j 2-LAMP vaccine
- Subject who has participated in a clinical study of ASP4070 and received a vaccination of the study drug.
Sites / Locations
- Site JP00001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ASP4070 4 mg
ASP4070 1 mg
Placebo
Arm Description
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
Outcomes
Primary Outcome Measures
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but does not interfere with the activities of daily living)
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.
Secondary Outcome Measures
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
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.
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
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.
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
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.
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
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.
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.
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.
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Sneezing count per 30 minutes were measured during chamber exposure.
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.
Local reactions: pain, tenderness, erythema/redness and induration/swelling
Systemic reactions: nausea/vomiting, diarrhea, headache, fatigue and myalgia
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.
Full Information
NCT ID
NCT03101267
First Posted
April 2, 2017
Last Updated
June 16, 2020
Sponsor
Astellas Pharma Inc
Collaborators
Immunomic Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03101267
Brief Title
A Dose-finding Study of ASP4070
Official Title
Phase 2 Dose-finding Study of ASP4070 - A Randomized, Double-blind, Placebo-controlled, Dose-finding Study in Patients With Cedar Pollinosis Using an Environmental Exposure Chamber -
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
October 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Immunomic Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
Cedar pollinosis, ASP4070, DNA plasmid vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP4070 4 mg
Arm Type
Experimental
Arm Description
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
Arm Title
ASP4070 1 mg
Arm Type
Experimental
Arm Description
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
Intervention Type
Drug
Intervention Name(s)
ASP4070
Intervention Description
Intradermal vaccination at 2-week intervals
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intradermal vaccination at 2-week intervals
Primary Outcome Measure Information:
Title
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
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but does not interfere with the activities of daily living)
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.
Time Frame
Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)
Secondary Outcome Measure Information:
Title
Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
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.
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
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.
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
Very severe (difficult to tolerate and interfered with the activities of daily living)
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
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.
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure
Description
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)
Mild (symptoms present but easily tolerated)
Moderate (awareness of symptoms; bothersome, but tolerable)
Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)
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.
Time Frame
Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
Title
Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure
Description
Time point when the score of nasal or eye symptom worsens by 1 or more as compared to before cedar pollen exposure were assessed.
Time Frame
Days 127, 155 and 183, from the start of cedar pollen exposure for up to 180 minutes
Title
Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
Description
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.
Time Frame
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
Title
Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
Description
Sneezing count per 30 minutes were measured during chamber exposure.
Time Frame
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
Title
Number of Participants With Adverse Events (AE) During the Primary Study Period
Description
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
Time Frame
From first dose of study drug up to the end of primary study period (up to 7 days after Day 183)
Title
Number of Participants With Serious Adverse Events (SAE) During the Long-Term Safety Follow-Up Period
Description
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.
Time Frame
Up to 9 months after the end of primary study period (primary study period was up to 7 days after Day 183)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject who has exhibited symptoms of cedar pollinosis, consisting of nasal symptoms (sneezing, nasal discharge or nasal obstruction) and eye symptoms (itchy eyes or watery eyes) during the pollen dispersal seasons in 2016 and 2017
Subject who is positive for the Japanese red cedar (JRC) pollen-specific serum IgE antibody test
At screening, subject whose score has worsened compared to baseline over 120 to 180 minutes after cedar pollen exposure in a chamber
Exclusion Criteria:
Subject who has positive the test result of serum IgE antibody specific to other antigen than JRC pollen at screening
Subject who has received specific immunotherapy (including desensitization therapy) for cedar pollinosis in the past
Subject who has received specific or non-specific immunotherapy within 5 years prior to screening
Subject who has received laser therapy or surgery for the treatment of nasal symptoms within 3 years prior to screening.
Subject who has a history of allergic reactions such as anaphylactic shock and exanthema generalized caused by food and/or medical products in the past
Subject who has a positive test result for hepatitis B surface (HBs) antigen or anti-hepatitis C virus (HCV) antibody
Subject who has nasal disease that may interfere with the evaluation
Subject who has autoimmune disease or other serious primary disease
Subject who was diagnosed with immunodeficiency in the past
Subject who has a complication of seasonal allergic rhinitis (due to allergens other than Japanese cedars or cypress), perennial allergic rhinitis, rhinitis medicamentosa, or non-allergic rhinitis that requires medical treatment
Subject who has a complication of cardiovascular disease
Subject who has a complication of hepatic disease
Subject who has a complication of renal disease
Subject who has a complication of respiratory disease
Subject has a complication of malignant tumor or has been diagnosed with or has received treatment for malignant tumor within 5 years prior to the first vaccination of the study drug
Subject who was diagnosed with schizophrenia, other mental conditions
Subject who has a complication that may have an impact on the results of the local or systemic reaction
Subject who has received a vaccination of Cry j 2-LAMP vaccine
Subject who has participated in a clinical study of ASP4070 and received a vaccination of the study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site JP00001
City
Shinjuku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=361
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
A Dose-finding Study of ASP4070
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