Clinical trial NCT03101267: A Dose-finding Study of ASP4070
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 -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Cedar pollinosis
ASP4070
DNA plasmid vaccine
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Immunomic Therapeutics, Inc.
First posted: 2017-04-05
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
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
timeFrame: Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)
Secondary outcomes:
measure: Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure
timeFrame: Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183
measure: Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure
timeFrame: Days 127, 155 and 183, from the start of cedar pollen exposure for up to 180 minutes
measure: Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure
timeFrame: 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
measure: Sneezing Count Per 30 Minutes During Cedar Pollen Exposure
timeFrame: 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
measure: Number of Participants With Adverse Events (AE) During the Primary Study Period
timeFrame: From first dose of study drug up to the end of primary study period (up to 7 days after Day 183)
measure: Number of Participants With Serious Adverse Events (SAE) During the Long-Term Safety Follow-Up Period
timeFrame: Up to 9 months after the end of primary study period (primary study period was up to 7 days after Day 183)
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: Site JP00001
state: Tokyo
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: