A Dose-finding Study of ASP4070
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: ASP4070; Placebo
Intervention description: Intradermal vaccination at 2-week intervals; Intradermal vaccination at 2-week intervals
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Cedar pollinosis; ASP4070; DNA plasmid vaccine

Summary:

      The objective of this study was to evaluate the efficacy, safety, and dose-response of
      ASP4070 vaccinated in patients with cedar pollinosis.
    

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.