Rhinitis, Allergic, SeasonalPhase 2NCT03101267
A Dose-finding Study of ASP4070
A Phase 2 study testing ASP4070 in people with Rhinitis, Allergic, Seasonal, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- ASP4070
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- 13 Apr 2017to 27 Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 -
The objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis.
Read the 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.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- ASP4070, Placebo
- Keywords
- Cedar pollinosis, ASP4070, DNA plasmid vaccine
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP4070Drug
Intradermal vaccination at 2-week intervals
PlaceboDrug
Intradermal vaccination at 2-week intervals
| Study group | Role | What they receive |
|---|---|---|
| ASP4070 4 mg | Experimental | Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals. Receives: Drug: ASP4070 |
| ASP4070 1 mg | Experimental | Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals. Receives: Drug: ASP4070 |
| Placebo | Placebo comparator | Participants received Placebo 8 times by intradermal vaccination at 14-day intervals. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)
Secondary outcomes (15)
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.
Measured: 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)
- 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)
Measured: 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)
- 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)
Measured: 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)
- 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)
Measured: 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)
- 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)
Measured: 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)
- 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.
Measured: 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)
- 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)
Measured: 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)
- 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)
Measured: 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)
- 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.
Measured: 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)
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
- Local reactions: pain, tenderness, erythema/redness and induration/swelling
- Systemic reactions: nausea/vomiting, diarrhea, headache, fatigue and myalgia
Measured: 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.
Measured: Up to 9 months after the end of primary study period (primary study period was up to 7 days after Day 183)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start13 Apr 2017
- Primary completion26 Jan 2018
- Study completion27 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immunomic Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101267
- Sponsor's protocol ID
- 4070-CL-0020
- Status last verified
- Nov 2024
- First submitted
- 2 Apr 2017
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 -
- ClinicalTrials.gov ID
- NCT03101267
- Acronym / sponsor ID
- 4070-CL-0020
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Cedar pollinosis, ASP4070, DNA plasmid vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Immunomic Therapeutics, Inc.
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 27 Oct 2018 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Posted 30 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASP4070 4 mg | Experimental | Drug: ASP4070Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals. |
| ASP4070 1 mg | Experimental | Drug: ASP4070Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received Placebo 8 times by intradermal vaccination at 14-day intervals. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP4070Intradermal vaccination at 2-week intervals | Drug | ASP4070 1 mg, ASP4070 4 mg |
| PlaceboIntradermal vaccination at 2-week intervals | Drug | Placebo |
Primary outcome
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
Time frame: Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)
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.
15 secondary outcomes
Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure
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
Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure
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
Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure
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
Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure
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
Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure
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
Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure
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
Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
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
Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
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
Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure
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
Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure
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
Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure
Time frame: 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
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
Sneezing Count Per 30 Minutes During Cedar Pollen 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
Number of Participants With Adverse Events (AE) During the Primary Study Period
Time frame: 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
Time frame: Up to 9 months after the end of primary study period (primary study period was up to 7 days after Day 183)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP4070 in people with Rhinitis, Allergic, Seasonal, run by Astellas Pharma Inc at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.