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Study of CM310 in Subjects With Allergic Rhinitis

Sponsor
Keymed Biosciences Co.Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05908032
Collaborator
(none)
200
Enrollment
2
Arms
10
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CM310
  • Biological: Placebo
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CM310 group

Biological: CM310
IL-4Rα monoclonal antibody
Placebo Comparator: Placebo

Biological: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events (AEs) [Week 12]

    Incidence (including number of patients, events and percentage) of adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Keymed Biosciences Co.Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Keymed Biosciences Co.Ltd
ClinicalTrials.gov Identifier:
NCT05908032
Other Study ID Numbers:
  • CM310-107206
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic

Study Results

No Results Posted as of Jun 18, 2023