A Dose-finding Study of ASP4070

Astellas

Status and phase: Completed; Phase 2

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: Placebo; Drug: ASP4070

Study type: Interventional

Funder types: Industry

Identifiers

NCT03101267

4070-CL-0020

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

ASP4070 4 mg

Experimental group

Description:

Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.

Treatment:

Drug: ASP4070

ASP4070 1 mg

Experimental group

Description:

Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.

Treatment:

Drug: ASP4070

Placebo

Placebo Comparator group

Description:

Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.

Treatment:

Drug: Placebo