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New treatment option for Moderate to Severe Asthma
Official title A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma
ClinicalTrials.gov ID: NCT07372287
What this study is testing
What is CM326?
CM326 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for moderate to severe asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- 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...
- Prior autoimmune disease or inflammatory treatment with biologic agents/systemic immunosuppressive agents within 8 weeks or 5 half-lives (whichever...
- Previous history of known or suspected immunosuppression, including a history of invasive opportunistic infection, even if the infection has...
- 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...
See the full eligibility criteria
Who can join
- 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...
- Asthma Control Questionnaire-5 (ACQ-6) score ≥1.5.
- people 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.
- ≥ 80% compliance with usual asthma controller therapy in people during the screening phase
- Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.
What rules you out
- 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...
- 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...
- 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...
- 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.
- Major surgery within 8 weeks prior to informed consent requiring general anesthesia or hospitalization for \> 1 day .
- Received biological agents with the same therapeutic purpose within 4 months or 5 half-lives (whichever is longer) before signing the informed consent.
- Have been enrolled in a clinical trial of any drug or medical device within 3 months before signing informed consent, or are within the follow-up period of a clinical study or the five half-lives of the trial drug...
- Received immune globulin or blood products within 30 days before informed consent.
- people treated with systemic corticosteroids other than for the treatment of asthma from 8 weeks before signing the informed consent to the date of randomization.
- Received live or attenuated vaccine within 3 months before informed consent.
- Initiation of desensitization therapy within 3 months before informed consent.
- Underwent bronchial thermoplasty within 12 months before informed consent.
- Current smokers or former smokers who quit smoking less than 6 months or former smokers who quit smoking more than 6 months with a smoking history of more than 10 pack-years.
- At screening, any infectious disease screening indicator meets one of the following criteria: a. HBsAg positive b. HBsAg negative , HBcAb positive, HBV DNA exceed the lower limit of quantitation (LLOQ) or 1000 copies/mL...
- At screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 × upper limit of normal (ULN), or serum creatinine (Cr) \> 1.5 × ULN.
- Allergy or intolerance to components of CM326 injection or placebo or history of severe drug allergy or anaphylactic shock.
- people who have used heavy alcohol within 3 months before screening.
- History of drug abuse within 5 years before signing informed consent.
- Females with a positive pregnancy test, pregnant females, or lactating females.
- The investigator considers that there are any conditions that may prevent the subject from completing the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.