Moderate to Severe AsthmaPhase 3NCT07372287
A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma
A Phase 3 study testing CM326 in people with Moderate to Severe Asthma, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Moderate to Severe Asthma
- What is being tested?
- CM326
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2026to 31 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 maintained stable treatment regimen and dosage for at least 1 month before signing the informed consent.
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- 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.
- ≥ 80% compliance with usual asthma controller therapy in subjects 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.
Who cannot join
- 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.
- 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.
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- 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 (whichever is longer) before signing informed consent.
- Received immune globulin or blood products within 30 days before informed consent.
- Subjects 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 (500 IU/mL)(whichever is lower) c. HCV antibody positive, HCV RNA exceed the LLOQ or 1000 copies/mL(whichever is lowerd). d.HIV antibody positive. e.Treponema pallidum antibody positive
- 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.
- Subjects 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Jie Ming Qu, PHDD, 18901661180, jmqu0906@163.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma
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.
- Conditions
- Moderate to Severe Asthma
- Being tested
- CM326, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM326Drug
subcutaneous injection
PlaceboOther
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CM326 | Experimental | CM326 subcutaneous (SC) Receives: Drug: CM326 |
| Placebo | Placebo comparator | placebo, subcutaneous (SC) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of severe asthma exacerbations at Week 52
Severe asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, or an inpatient hospitalization due to asthma. The annualized rate of severe asthma exacerbations is presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Measured: week 52
Secondary outcomes (24)
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
Change from baseline in forced expiratory volume in 1 second taken before bronchodilator use will be reported.
Measured: week 52
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) at Week 52
A loss of asthma control (LOAC) event refers to any of the following situations experienced by the participants: continuous use of rescue medication, a decrease in FEV1 compared to baseline, an increase in ICS compared to baseline, a decrease in morning or evening PEF, or a severe asthma exacerbation.
Measured: week 52
Annualized rate of severe asthma exacerbations associated with emergency room visit, or hospitalization at Week 52
Severe asthma exacerbation which leads to an emergency department visit.
Measured: week 52
Time to the first onset of the severe asthma exacerbation event
Severe asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first severe asthma exacerbation will be reported.
Measured: week 52
Time to the onset of the first event of LOAC
Time to first LOAC event will be reported.
Measured: week52
Change from baseline in Pre-bronchodilator FEV1 percentage of predicted value (FEV1% Pred) at each evaluation time point
Change from baseline in the ratio of FEV1 to the predicted value taken before bronchodilator use will be reported.
Measured: week 52
Change from baseline in Pre-bronchodilator Forced vital capacity (FVC) at each evaluation time point
Change from baseline in forced vital capacity taken before bronchodilator use will be reported.
Measured: week 52
Change from baseline in Pre-bronchodilator Maximal Mid-Expiratory FlowForced Expiratory Flow (MMEF) at each evaluation time point
Change from baseline in maximal mid-expiratory flow taken before bronchodilator use will be reported.
Measured: week 52
Change from baseline in post-bronchodilator FEV1 at each evaluation time point
Change from baseline in forced expiratory volume in 1 second taken after bronchodilator use will be reported.
Measured: week 52
Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at each evaluation time
The mean weekly daytime PEF is calculated as the average of daytime PEF measurements from Day -6 through the visit day. The mean weekly nocturnal PEF is calculated as the average of nighttime PEF measurements from Day -7 through Day -1 prior to the visit.
Measured: week 52
Change from baseline in the Asthma Control Questionnaire-6(ACQ-6) score at each evaluation time point
Asthma Control Questionnaire-6(ACQ-6) is a questionnaire consisting of 6 questions used to evaluate the degree of asthma control in the past week. The score of each question ranges from 0 to 6 (on a 7-point scale), with a higher score indicating poorer symptom control. The mean ACQ-6 score is the mean of the 6 questions.
Measured: week 52
Proportion of participants with an ACQ-6 Score improvement of ≥0.5 points from baseline at each evaluation time point
Individual changes of at least 0.5 are considered to be clinically meaningful, and a decrease of at least 0.5 is the responder definition for ACQ-6.
Measured: week 52
Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) score at each evaluation time point
Asthma Quality of Life Questionnaire (AQLQ(S)+12)is a questionnaire consisting of 32 questions used to evaluate the quality of life of asthma participants in the past 2 weeks. Each question is scored from 1 to 7 (on a 7-point scale) based on the severity, with a higher score indicating better quality of life.
Measured: week 52
Proportion of participants with an (AQLQ(S)+12) Score improvement of ≥0.5 points from baseline at each evaluation time point
The responder definition for AQLQ(s)+12 is 0.5-point improvement from baseline.
Measured: week 52
Change from baseline in asthma symptom score at each evaluation time point
The asthma symptom score comprises 10 items (5 for the morning and 5 for the night). The item scores range from "0" (no symptoms, no nocturnal awakenings, or no activity limitation) to "4" (very severe symptoms, inability to sleep, or extreme activity limitation). The daily asthma symptom diary score is the average of 10 items (the night assessment value of the previous day and the morning assessment value of the next day).
Measured: week 52
Change from baseline in weekly mean rescue medication use at each evaluation
Change from baseline in the average weekly dose of rescue medication will be reported.
Measured: week 52
Change from baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score at each evaluation time point
The European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems), reflecting the increasing levels of difficulty. The questionnaire also includes a visual analog scale, where participants will rate their current health status within the range of 0 to 100, with 0 representing the worst imaginable health state and 100 indicated the best health state
Measured: week 52
Incidence and severity of Adverse events (AEs)
The severity of adverse events is recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. The incidence of participants with adverse events (AE) will be calculated.
Measured: week 64
Blood drug concentration of CM326
Measured: week 64
Change from baseline fractional exhaled nitric oxide (FeNO)
Evaluate the changes from baseline in FeNO at each visit point.
Measured: week 64
Change from baseline in peripheral blood eosinophil
Evaluate the changes from baseline in blood eosinophil count at each visit point.
Measured: week 64
Change from baseline in total serum IgE
Evaluate the changes from baseline in total serum IgE at each visit point.
Measured: week 64
Change from baseline in interleukin-5
Evaluate the changes from baseline in blood serum IgE at each visit point.
Measured: week 64
Incidence of anti-drug antibodies (ADAs)
Measured: week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start23 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372287
- Sponsor's protocol ID
- CM326-004
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT07372287
- Acronym / sponsor ID
- CM326-004
- Conditions
- Moderate to Severe Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| CM326 | Experimental | Drug: CM326CM326 subcutaneous (SC) |
| Placebo | Placebo comparator | Other: Placeboplacebo, subcutaneous (SC) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM326subcutaneous injection | Drug | CM326 |
| Placebosubcutaneous injection | Other | Placebo |
Primary outcome
Annualized rate of severe asthma exacerbations at Week 52
Time frame: week 52
Severe asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, or an inpatient hospitalization due to asthma. The annualized rate of severe asthma exacerbations is presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
24 secondary outcomes
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
Time frame: week 52
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) at Week 52
Time frame: week 52
Annualized rate of severe asthma exacerbations associated with emergency room visit, or hospitalization at Week 52
Time frame: week 52
Time to the first onset of the severe asthma exacerbation event
Time frame: week 52
Time to the onset of the first event of LOAC
Time frame: week52
Change from baseline in Pre-bronchodilator FEV1 percentage of predicted value (FEV1% Pred) at each evaluation time point
Time frame: week 52
Change from baseline in Pre-bronchodilator Forced vital capacity (FVC) at each evaluation time point
Time frame: week 52
Change from baseline in Pre-bronchodilator Maximal Mid-Expiratory FlowForced Expiratory Flow (MMEF) at each evaluation time point
Time frame: week 52
Change from baseline in post-bronchodilator FEV1 at each evaluation time point
Time frame: week 52
Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at each evaluation time
Time frame: week 52
Change from baseline in the Asthma Control Questionnaire-6(ACQ-6) score at each evaluation time point
Time frame: week 52
Proportion of participants with an ACQ-6 Score improvement of ≥0.5 points from baseline at each evaluation time point
Time frame: week 52
Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) score at each evaluation time point
Time frame: week 52
Proportion of participants with an (AQLQ(S)+12) Score improvement of ≥0.5 points from baseline at each evaluation time point
Time frame: week 52
Change from baseline in asthma symptom score at each evaluation time point
Time frame: week 52
Change from baseline in weekly mean rescue medication use at each evaluation
Time frame: week 52
Change from baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score at each evaluation time point
Time frame: week 52
Incidence and severity of Adverse events (AEs)
Time frame: week 64
Blood drug concentration of CM326
Time frame: week 64
Change from baseline fractional exhaled nitric oxide (FeNO)
Time frame: week 64
Change from baseline in peripheral blood eosinophil
Time frame: week 64
Change from baseline in total serum IgE
Time frame: week 64
Change from baseline in interleukin-5
Time frame: week 64
Incidence of anti-drug antibodies (ADAs)
Time frame: week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CM326 in people with Moderate to Severe Asthma, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of severe asthma exacerbations at Week 52 (time frame: week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.