Seasonal Allergic Rhinitis
Conditions
Brief summary
This study is a multicenter, single arm phase II clinical study mainly evaluating the efficacy of CM310 in patients with seasonal allergic rhinitis.
Detailed description
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.
Interventions
BIOLOGICALCM310
CM310 injection
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18-65. * Understand the study and sign the Informed Consent Form voluntarily. * Take effective contraception measures throughout the study period.
Exclusion criteria
* Used other investigational drugs. * Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM310. * Plan to participate in other studies during this clinical trial. * With malignant or benign tumors of the nasal cavity. * Other reasons the researcher believes that the subject is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline mean of daily retrospective total nasal of symptom score (rTNSS) | Up to week 12 | The total score of nasal symptoms (TNSS) is the sum of four symptom scores: runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3 points. |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed