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Completed

NCT Number: NCT05908721

Study of CM310 in Patients With Allergic Rhinitis

This study is a multicenter, single arm, open-label phase II clinical study mainly evaluating the safety of CM310 in patients with allergic rhinitis.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tong-Ren hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM310

Biological

IL-4Rα monoclonal antibody

Primary outcomes

  1. Incidence of adverse events

    Time frame: Week 12

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

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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