Phase 2
Completed N=150
A Dose-finding Study of ASP4070
Rhinitis, Allergic, Seasonal
Source: ClinicalTrials.gov NCT03101267 ↗
Enrolled (actual)
150
Serious AEs
1.3%
Results posted
Jun 2020
Primary outcomePrimary: 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 — 2.04; 1.91; 1.98 units on a scale — p=0.777
Summary
The objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
2.04; 1.91; 1.98 | 0.777 |
| SECONDARY Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure |
4.21; 4.07; 4.02; 3.46; 3.20; 3.32 | 0.710 |
| SECONDARY Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure |
0.57; 0.47; 0.49; 0.46; 0.39; 0.39 | 0.502 |
| SECONDARY Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure |
1.54; 1.30; 1.42; 1.29; 1.12; 1.27 | 0.472 |
| SECONDARY Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure |
1.14; 1.26; 1.18; 0.91; 0.90; 0.92 | 0.822 |
| SECONDARY Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure |
0.97; 1.03; 0.93; 0.80; 0.79; 0.74 | 0.864 |
| SECONDARY Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure |
0.83; 0.96; 0.61; 0.62; 0.83; 0.50 | 0.336 |
| SECONDARY Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure |
0.51; 0.58; 0.44; 0.36; 0.49; 0.33 | 0.623 |
| SECONDARY Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure |
0.32; 0.38; 0.17; 0.26; 0.34; 0.17 | 0.157 |
| SECONDARY Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure |
4.08; 3.99; 3.70; 3.28; 3.24; 3.07 | 0.433 |
| SECONDARY Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure |
5.04; 5.02; 4.63; 4.08; 4.03; 3.82 | 0.505 |
| SECONDARY Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure |
15.0; 15.0; 30.0; 22.5; 30.0; 15.0 | — |
| SECONDARY Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure |
0.57; 0.80; 0.68; 1.21; 1.35; 1.43 | — |
| SECONDARY Sneezing Count Per 30 Minutes During Cedar Pollen Exposure |
0.4; 0.8; 1.1; 1.0; 1.0; 1.3 | — |
| SECONDARY Number of Participants With Adverse Events (AE) During the Primary Study Period |
49; 44; 28; 33; 33; 18 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAE) During the Long-Term Safety Follow-Up Period |
0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03101267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.