Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2017-04-13
2018-10-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of ASP4070 to Confirm Safety and Immunological Response in Patients With Pollen Allergy
NCT02469688
Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
NCT00791102
A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies
NCT00720278
A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites
NCT04184895
A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis
NCT00407927
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ASP4070 4 mg
Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
ASP4070
Intradermal vaccination at 2-week intervals
ASP4070 1 mg
Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
ASP4070
Intradermal vaccination at 2-week intervals
Placebo
Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
Placebo
Intradermal vaccination at 2-week intervals
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ASP4070
Intradermal vaccination at 2-week intervals
Placebo
Intradermal vaccination at 2-week intervals
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
20 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Immunomic Therapeutics, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site JP00001
Shinjuku, Tokyo, Japan
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Link to results on the Astellas Clinical Study Results website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4070-CL-0020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.