A Multicenter, Single Arm Phase II Clinical Study Evaluating the Efficacy of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis

Keymed Biosciences Co.Ltd1 site in 1 country100 target enrollmentMarch 30, 2024

ConditionsSeasonal Allergic Rhinitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Seasonal Allergic Rhinitis
Sponsor: Keymed Biosciences Co.Ltd
Enrollment: 100
Locations: 1
Primary Endpoint: Changes from baseline mean of daily retrospective total nasal of symptom score (rTNSS)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 30, 2024

End Date

March 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Keymed Biosciences Co.Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18-
•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 CM
•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.

Outcomes

Primary Outcomes

Changes from baseline mean of daily retrospective total nasal of symptom score (rTNSS)

Time Frame: 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.