RecruitingPhase 2Phase 3NCT05761028

A Study of CM310 in Subjects With Moderate to Severe Asthma

A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Asthma


Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Enrollment

600 participants

Start Date

Apr 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ/Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe asthma. The study consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 4-week safety follow-up period.


Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying an experimental drug called CM310 — a biologic injection (similar to dupilumab) that blocks a key inflammatory pathway — in people with moderate to severe asthma that is not well-controlled. **You may be eligible if...** - You are 12–75 years old and weigh at least 40 kg - You have been diagnosed with asthma for at least 1 year - Your breathing tests (spirometry) show reduced lung function, and you respond to a bronchodilator - You have had asthma symptoms that are not well-controlled despite current medication, or have needed oral steroids or been hospitalized for asthma **You may NOT be eligible if...** - You have another significant lung disease (e.g. COPD, active lung infection) - You have been on high-dose oral steroids for a long time or received biologic asthma therapy recently - You smoke heavily (over 10 cigarettes/day) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCM310

CM310 Recombinant Humanized Monoclonal Antibody Injection

OTHERPlacebo

Placebo


Locations(1)

China-Japan Friendship Hospital

Beijing, Beijin, China

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NCT05761028


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