Study of CM310 in Patients With Allergic Rhinitis

Keymed Biosciences

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Biological: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT05908721

CM310-107107

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

CM310

Experimental group

Description:

Subcutaneous injection

Treatment:

Biological: CM310