A Dose-finding Study of ASP4070

Astellas Pharma Inc150 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Rhinitis, Allergic, Seasonal

Interventions

ASP4070DRUG

Intradermal vaccination at 2-week intervals

PlaceboDRUG

Intradermal vaccination at 2-week intervals

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (1)

Site JP00001

Shinjuku, Tokyo, Japan

Outcomes

Primary Outcomes

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) 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.

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 Outcomes

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) 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 did not interfere with the activities of daily living) 4. 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.