A Dose-finding Study of ASP4070

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Rhinitis, Allergic, Seasonal	Drug: ASP4070; Drug: Placebo	Phase 2

Detailed Description:

Subjects will be vaccinated with ASP4070 or placebo at 2 week intervals. Clinical symptoms will be 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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Phase II Dose-finding Study of ASP4070 -A Randomized, Double-blind, Placebo-controlled, Dose-finding Study in Environmental Exposure Chamber in Patients With Cedar Pollinosis-
Actual Study Start Date :	April 13, 2017
Actual Primary Completion Date :	January 26, 2018
Estimated Study Completion Date :	October 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: ASP4070 Lower dose group; Intradermal vaccination at 2-week intervals	Drug: ASP4070; Intradermal vaccination at 2-week intervals
Experimental: ASP4070 higher dose group; Intradermal vaccination at 2-week intervals	Drug: ASP4070; Intradermal vaccination at 2-week intervals
Placebo Comparator: Placebo group; Intradermal vaccination at 2-week intervals	Drug: Placebo; Intradermal vaccination at 2-week intervals

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline in Total Nasal Symptom Score (3TNSS) after 120 to 180 minutes in an exposure chamber [ Time Frame: 4, 8 and 12 Weeks after vaccination ]
   The 3TNSS is the total of the 3 individual nasal symptom scores for sneezing, nasal discharge and nasal congestion. Baseline is pre-exposure.

Secondary Outcome Measures :

1. 3 Total Nasal Symptom Score (3TNSS) after 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
   The 3TNSS is the total of the 3 individual nasal symptom scores for sneezing, nasal discharge and nasal congestion.
2. 4 Total Nasal Symptom Score (4TNSS) after 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
   The 4TNSS is the total of the 4 individual nasal symptom scores for sneezing, nasal discharge, nasal congestion and itchy nose.
3. Nasal Symptom Score for sneezing after 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
   Sneezing will be evaluated as nasal symptom.
4. Nasal Symptom Score for nasal discharge after 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
   Nasal discharge will be evaluated as nasal symptom.
5. Nasal Symptom Score for nasal congestion after 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
   Nasal congestion will be evaluated as nasal symptom.
6. Nasal Symptom Score for itchy nose after 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
   Itchy nose will be evaluated as nasal symptom.
7. Total Eye Symptom Score to 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
   Total eye symptom score is the total of the 2 individual eye symptom scores for itchy eyes and watery eyes.
8. Eye Symptom Score for itchy eyes after 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
   Itchy eyes will be evaluated as eye symptom.
9. Eye Symptom Score for watery eyes after 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
   Watery eyes will be evaluated as eye symptom.
10. Total Nasal and Eye Symptom Score after 180 minutes in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
    This score is the total of the 3TNSS and the total eye symptom score.
11. Time to the onset of nasal or eye symptoms from the start of pollen exposure in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
    The onset time of nasal or eye symptom will be evaluated as pollinosis symptom.
12. Amount of nasal discharge measured every 30 minutes during pollen exposure in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
    Amount of nasal discharge will be evaluated as nasal symptom.
13. Frequency of sneezing measured every 30 minutes during pollen exposure in an exposure chamber [ Time Frame: Up to 12 Weeks after last vaccination ]
    Frequency of sneezing will be evaluated as nasal symptom.
14. Safety assessed by incidence of adverse events [ Time Frame: Up to 10 months ]
    Adverse events will be coded using MedDRA. An adverse event with onset at any time from the time of informed consent until 13 weeks after last vaccination.
15. Safety assessed by standard 12-lead electrocardiogram [ Time Frame: Up to 10 months ]
    After the subject has been resting comfortably in a supine position, ECGs will be recorded with the subject in the supine position.
16. Safety assessed by vital signs: Body temperature [ Time Frame: Up to 10 months ]
    Body temperature will be measured in an axilla.
17. Safety assessed by vital signs: Sitting blood pressure [ Time Frame: Up to 10 months ]
    Blood pressure will be measured in a sitting position.
18. Safety assessed by vital signs: Sitting pulse rate [ Time Frame: Up to 10 months ]
    Pulse rate will be measured in a sitting position.
19. Safety assessed by laboratory tests: Hematology [ Time Frame: Up to 10 months ]
    For quantitative laboratory measurements descriptive statistics will be used to summarize results and change from baseline by treatment group and time point.
20. Safety assessed by laboratory tests: Biochemistry [ Time Frame: Up to 10 months ]
    For quantitative laboratory measurements descriptive statistics will be used to summarize results and change from baseline by treatment group and time point.
21. Safety assessed by laboratory tests: Urinalysis [ Time Frame: Up to 10 months ]
    For qualitative laboratory measurements descriptive statistics will be used to summarize results and change from baseline by treatment group and time point.
22. Safety assessed by serious adverse events reported up to 12 months after the last vaccination (long-term safety follow-up) [ Time Frame: Up to 12 months after the last vaccination ]
    Adverse events will be coded using MedDRA. An adverse event with onset at any time from 13 weeks until 12 months after last vaccination.

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 64 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Japan
Site JP00001
Shinjuku, Tokyo, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Immunomic Therapeutics, Inc.

Investigators

Study Director:	Medical Director	Astellas Pharma Inc

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT03101267 History of Changes
Other Study ID Numbers:	4070-CL-0020
First Posted:	April 5, 2017
Last Update Posted:	February 9, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Astellas Pharma Inc:

Cedar pollinosis; ASP4070; DNA plasmid vaccine

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases	Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs