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NCT06171074 Clinical Trial

Study of CM310 in Subjects With Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06171074
Other study ID # CM310-107105
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 30, 2024
Est. completion date March 30, 2025

Study information
Verified date December 2023
Source Keymed Biosciences Co.Ltd
Contact Qian Jia
Phone 028-88610620
Email qianjia@keymedbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a multicenter, single arm phase II clinical study mainly evaluating the efficacy of CM310 in patients with seasonal allergic rhinitis.

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 information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date March 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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-4Ra 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

Related Conditions & MeSH terms

Intervention

Biological:
• CM310
CM310 injection

Locations
Country Name City State
China Beijing Tong-Ren hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes from baseline mean of daily retrospective total nasal of symptom score (rTNSS) 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. Up to week 12
See also
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