Study of CM310 in Subjects With Seasonal Allergic Rhinitis
Phase 2
Not yet recruiting
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Biological: CM310
- Registration Number
- NCT06171074
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CM310 CM310 CM310, Subcutaneous injection
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beijing Tong-Ren hospital
🇨🇳Beijing, China