A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma (NCT07372287) | Clinical Trial Compass
RecruitingPhase 3
A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma
China230 participantsStarted 2026-01-23
Plain-language summary
This study is a multi-center, randomized, double-blind, placebo-controlled Phase â…¢ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to severe asthma.
The study consists of three periods, including an up to 4-week screening period, a 52-week double-blind randomized treatment period, and a 12-week safety follow-up period.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Understand the study and voluntarily sign the informed consent form.
✓. Age ≥18 and ≤80 years old, male or female, weight ≥40 kg.
✓. The subject has been diagnosed with asthma for at least 1 year.
✓. Pre-bronchodilator FEV1 measured ≤80% of the normal predicted value.
✓. A positive bronchodilation test within 24 months before informed consent or at screening.
✓. The subject has received medium-to-high dose ICS combined with at least one control drug, such as LABA, LAMA, LTRA, Oral corticosteroids, theophylline, for at least 3 months before signing the informed consent, and maintained stable treatment regimen and dosage for at least 1 month before signing the informed consent.
✓. Asthma Control Questionnaire-5 (ACQ-6) score ≥1.5.
✓. Subjects must have experienced at least one severe asthma exacerbation event within 12 months before informed consent, and have not experienced a severe asthma exacerbation event within 30 days before informed consent.
Exclusion criteria
✕. Chronic obstructive pulmonary disease (COPD) without asthma or other lung disease that may impair lung function, as judged by the investigator.
✕. Have systemic diseases other than asthma that result in an elevated peripheral blood eosinophil count or other diseases such as helminth parasitic infections for which standard treatment is not received or does not respond.
What they're measuring
1
Annualized rate of severe asthma exacerbations at Week 52
. Prior autoimmune disease or inflammatory treatment with biologic agents/systemic immunosuppressive agents within 8 weeks or 5 half-lives (whichever is longer) prior to informed consent.
✕. Previous history of known or suspected immunosuppression, including a history of invasive opportunistic infection, even if the infection has resolved; or the presence of unusual frequent, recurrent, or prolonged infections.
✕. History of malignancy.
✕. The presence of any severe and/or uncontrolled medical condition that in the judgment of the investigator may affect the evaluation of the drug, including but not limited to: severe neurological disease, history of severe mental disorder, diabetes mellitus poorly controlled by intensive treatment.
✕. Active infection or acute infection requiring systemic anti-infective therapy from 4 weeks before enrollment to the time of randomization.
✕. A history of severe cardiovascular disease or clinically significant abnormalities identified by 12-lead electrocardiogram (ECG) during the screening phase.