Back to resultsStudy of CM310 in Subjects With Allergic Rhinitis
Primary Purpose
Allergic Rhinitis
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CM310
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria: Male or female aged 18-65. Understand the nature of research and sign the Informed Consent Form voluntarily. Take effective contraception measures throughout the study period. Exclusion Criteria: Used other investigational drugs. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CM310 group
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
Incidence (including number of patients, events and percentage) of adverse events.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05908032
Brief Title
Study of CM310 in Subjects With Allergic Rhinitis
Official Title
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis Under Background Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keymed Biosciences Co.Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of CM310 in patients with seasonal allergic rhinitis, and observing the quality of life, PK, PD characteristics, and immunogenicity of subjects.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CM310 group
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CM310
Intervention Description
IL-4Rα monoclonal antibody
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
Incidence (including number of patients, events and percentage) of adverse events.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18-65.
Understand the nature of research and sign the Informed Consent Form voluntarily.
Take effective contraception measures throughout the study period.
Exclusion Criteria:
Used other investigational drugs.
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.
12. IPD Sharing Statement
Learn more about this trial
Study of CM310 in Subjects With Allergic Rhinitis
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