Actively Recruiting
A Study of CM310 in Subjects With Moderate to Severe Asthma
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2023-12-15
600
Participants Needed
1
Research Sites
470 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of CM310 in Subjects With Moderate to Severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and voluntarily sign the informed consent form
- Age between 12 and 75 years, any gender, weighing at least 40 kg
- Diagnosed with asthma for at least 1 year with disease status meeting GINA 2022 criteria
- Pre-bronchodilator FEV1 at or below 80% of predicted normal value at screening and baseline
- Positive bronchodilation test (12% or more increase in FEV1 and at least 200 mL increase) within 24 months before consent or at screening
- Receiving stable medium-to-high dose inhaled corticosteroids combined with at least one control drug (LABA, LAMA, LTRA, theophylline) for at least 3 months, with stable dose for at least 1 month before consent
- Asthma Control Questionnaire-5 (ACQ-5) score of 1.5 or higher at screening and baseline
- Experienced at least one severe asthma exacerbation event within 12 months before consent, but none within 1 month before consent, including at least one during treatment with medium-to-high dose ICS
- Subjects and partners have no plans for children and agree to use highly effective contraception for 3 months after last study drug dose
You will not qualify if you...
- Received biologic agents for the same purpose within 6 months before consent
- Autoimmune disease or treatment with biologic or systemic immunosuppressive agents within 8 weeks or 5 half-lives before consent
- Received immune globulin or blood products within 30 days before consent
- Treated with systemic corticosteroids (except topical, ophthalmic, or intranasal) within 4 weeks before consent to randomization
- Received or planned to receive live or attenuated vaccine within 3 months before or during the study
- Started desensitization therapy within 3 months before consent
- Underwent bronchial thermoplasty within 12 months before consent
- Current smokers, recent quitters less than 6 months ago, or former smokers with over 10 pack-years
- Diagnosis of COPD or other lung diseases affecting lung function
- Active or acute infection requiring systemic treatment within 4 weeks before enrollment
- History of immunosuppression or recurrent unusual infections
- Recent or certain malignancies unless treated and stable for specified periods
- Severe or uncontrolled medical conditions that may interfere with drug evaluation
- Major surgery within 8 weeks before consent or planned surgery requiring general anesthesia during study
- Positive pregnancy test or pregnant or breastfeeding women
- Positive HIV or syphilis test
- Chronic hepatitis B or C infection
- Abnormal liver or kidney function beyond specified limits
- Systemic diseases causing elevated blood eosinophils or untreated parasitic infections
- Allergy or intolerance to study drug or placebo components
- Participation in another drug or device clinical trial within 3 months before consent
- Heavy alcohol use within 3 months before screening
- History of drug abuse within 5 years before consent
- Any condition preventing study completion or increasing risk as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijin, China, 100000
Actively Recruiting
Research Team
W
Wang Wenjuan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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