A Study of ASP4070 to Confirm Safety and Immunological Response in Patients With Pollen Allergy
A Phase 1 Study of ASP4070 to Confirm the Safety and Immunological Response in Patients With Cedar Pollinosis When Administered as Intramuscular Vaccination and as Intradermal Vaccination
1 other identifier
interventional
66
1 country
1
Brief Summary
Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen allergy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedStudy Start
First participant enrolled
June 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2016
CompletedOctober 31, 2024
October 1, 2024
5 months
June 5, 2015
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events developed after the first vaccination of the study drug
Up to Day 127
Secondary Outcomes (6)
Local reaction(injection site pain, erythema, swelling, and induration) and systemic reaction(queasy, vomiting, diarrhoea, headache, malaise, myalgia, allergic reaction, and pyrexia) due to the vaccination developed
within 14 days after the vaccination of the study drug
Vital signs (axillary temperature, blood pressure in a sitting position, and pulse rate in a sitting position)
Screening period, :Day 1, 15, 29, 43, 71, 99, and 127
12-lead ECG
Day 1 and 43
Laboratory test (hematology, biochemistry, and urinalysis)
Screening period, Day 1, 43, and 127
Prick test for Japanese cedar pollen
Screening period, Day 15, 29, 43, 71, 99 and 127
- +1 more secondary outcomes
Study Arms (10)
Part1 ASP4070 intramuscular vaccination group
EXPERIMENTALASP4070 high dose x 4 times
Part1 ASP4070 intradermal vaccination group
EXPERIMENTALASP4070 high dose x 4 times
Part2 ASP4070 intramuscular vaccination group 1
EXPERIMENTALASP4070 high dose x 4 times
Part2 ASP4070 intramuscular vaccination group 2
EXPERIMENTALASP4070 high dose x 1 time, Placebo x 3 times
Part2 Placebo intramuscular vaccination group
PLACEBO COMPARATORPlacebo x 4 times
Part2 ASP4070 intradermal vaccination group 1
EXPERIMENTALASP4070 high dose x 4 times
Part2 ASP4070 intradermal vaccination group 2
EXPERIMENTALASP4070 low dose x 4 times
Part2 ASP4070 intradermal vaccination group 3
EXPERIMENTALASP4070 high dose x 1 time, Placebo x 3 times
Part2 ASP4070 intradermal vaccination group 4
EXPERIMENTALASP4070 low dose x 1 time, Placebo x 3 times
Part2 Placebo intradermal vaccination group
PLACEBO COMPARATORPlacebo x 4 times
Interventions
intramuscular or intradermal
intramuscular or intradermal
Eligibility Criteria
You may qualify if:
- Subject who has medical history of nasal symptoms (sneezing, itching, rhinorrhoea, and congestion), and/or eye symptoms (itching, redness, and lacrimation) at least in 2 cedar pollen dispersion seasons prior to the screening test.
- Subject who had the Japanese cedar pollen-specific antibody test result of Class 3 or higher in the allergy test at screening.
- Subject who had a positive prick test result for Japanese cedar pollen in the screening test.
- Subject whose past and present medical conditions are considered medically stable.
You may not qualify if:
- Subject who had the test result of IgE antibody specific to other antigen than Japanese cedar pollen
- Subject who is scheduled to receive other vaccination during the primary study period.
- Subject who has received or is planning to receive vaccination of live vaccine within 28 days prior to the first vaccination of the study drug, and/or a subject who has received or is planning to receive vaccination of inactivated vaccine/toxoid within 7 days prior to the first vaccination of the study drug.
- Subject who received specific immunotherapy for cedar pollinosis in the past.
- Subject who received specific or non-specific immunotherapy within 5 years prior to the screening test.
- Subject who has used the following drug(s) prior to the first vaccination of the study drug:
- Within 56 days prior to the first vaccination of the study drug: Topical steroid, histamine H1-receptor antagonist, chemical mediator-isolation inhibitor, Th2 cytokine inhibitor, thromboxane A2 synthesis inhibitor, thromboxane A2 receptor antagonist, and/or leukotriene receptor antagonist
- Within 84 days prior to the first vaccination of the study drug: Systemic steroid, and antibody drugs (including anti-TNF-alpha antibody and anti-IgE monoclonal antibody)
- Subject who has history of allergic reactions such as anaphylactic shock and exanthema generalized caused by food and/or medical products (including vaccine) in the past, and/or a subject who had a fever of 39.0 degrees Celsius or higher within 2 days after the previous vaccination.
- Subject who has evidently high fever (37.5 degrees Celsius or higher) on the day of vaccination, or subject who has severe acute disease.
- Subject who meets any of the following criteria for laboratory and other tests at screening. The reference range for each test is the range used in the study site.
- Blood biochemistry test:
- AST (GOT) or ALT (GPT) value over 100 IU/L
- Creatinine value over 1.5 mg/dL
- Urine drug screening:
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Immunomic Therapeutics, Inc.collaborator
Study Sites (1)
Unknown Facility
Kanto, Japan
Related Links
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2015
First Posted
June 11, 2015
Study Start
June 18, 2015
Primary Completion
November 27, 2015
Study Completion
July 26, 2016
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/.