AsthmaPhase 2NCT05186909
A Study of CM310 in Subjects With Moderate to Severe Asthma
A Phase 2 study testing CM310 in people with Asthma, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- CM310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to 13 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are able to understand the nature of the study and voluntarily sign the ICF.
- Diagnosed with asthma according to the 2021 version of the GINA guidelines for at least 1 year.
- Pre-bronchodilator FEV1 measurement ≤ 80% of predicted normal value.
- Subjects must have experienced a severe asthma exacerbation within 12 months prior to screening, and have not experienced a severe asthma exacerbation within 1 month prior to screening.
Who cannot join
- Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
- Received biologics with the same therapeutic purpose within 6 months prior to screening, such as similar IL-4Rα antagonist, IL-5/5R, anti-IgE monoclonal antibody (mAb).
- Diagnosed with chronic obstructive pulmonary disease (COPD) or other lung disorders that may compromise lung function (including but not limited to idiopathic pulmonary fibrosis, allergic granulomatous angiitis, bronchopulmonary aspergillosis allergic, pulmonary tuberculosis, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Asthma
This study is a multi-center, randomized, double-blind, placebo-controlled Phase II 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 24-week randomized treatment period, and a 8-week safety follow-up period.
- Conditions
- Asthma
- Being tested
- CM310, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM310Drug
CM310 Recombinant Humanized Monoclonal Antibody Injection
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CM310 300mg Q2W | Experimental | CM310 is injected subcutaneously (SC) with a loading dose of 600 mg at the first dose, and then 300 mg each time, once every 2 weeks (Q2W) for a total of 12 doses. Receives: Drug: CM310 |
| CM310 150mg Q2W | Experimental | CM310 is injected subcutaneously (SC) with a loading dose of 300 mg at the first dose, and then 150 mg each time, once every 2 weeks (Q2W) for a total of 12 doses. Receives: Drug: CM310 |
| Placebo | Placebo comparator | Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
Absolute change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM310 treatment compared with placebo.
Measured: 12 weeks
Secondary outcomes (19)
Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Absolute change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Measured: 24 weeks
Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Measured: 24 weeks
Annualized rate of subjects experiencing severe asthma exacerbations.
Annualized rate of subjects experiencing severe asthma exacerbations during the 24-week randomized treatment period.
Measured: 24 weeks
Time to the first onset of the severe asthma exacerbation event.
Time from baseline to the first onset of the severe asthma exacerbation event.
Measured: 24 weeks
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) during the 24-week randomized treatment period.
Measured: 24 weeks
Time to the onset of the first event of LOAC.
Time from baseline to the onset of the first event of LOAC.
Measured: 24 weeks
FEV1 percentage of predicted value (FEV1% Pred)
FEV1 percentage of predicted value (FEV1% Pred)
Measured: 32 weeks
Peak diurnal and nocturnal expiratory flow (PEF)
Peak diurnal and nocturnal expiratory flow (PEF)
Measured: 32 weeks
Forced vital capacity (FVC)
Forced vital capacity (FVC)
Measured: 32 weeks
Maximal mid-expiratory flow (MMEF)
Maximal mid-expiratory flow (MMEF)
Measured: 32 weeks
Change from baseline of FEV1 after the use of bronchodilator.
Change from baseline of FEV1 after the use of bronchodilator.
Measured: 32 weeks
Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point.
The ACQ-5 is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 (on a 7-point scale) according to its severity. The higher the score, the less satisfactory symptom control is.
Measured: 32 weeks
Change from baseline in asthma symptom score at each evaluation time point.
Patients will record total symptom scores in morning（a 0-4 scale, with 0=no symptoms, 4=inability to fall asleep at night due to symptoms) and afternoon (a 0-5 scale, with 0=no symptoms, 5=severe symptoms, unable to work or perform daily activities).
Measured: 32 weeks
Incidence of Adverse events (AEs)
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Measured: 32 weeks
Trough concentration at steady-state of CM310
To evaluate the trough concentration at steady-state of CM310 for each dose group. Population pharmacokinetic analysis is performed using a nonlinear mixed-effects model.
Measured: 32 weeks
Human thymus and activation-regulated chemokine (TARC)
Change from baseline in TARC at each evaluation time point for each dose group.
Measured: 32 weeks
Fractional exhaled nitric oxide (FeNO).
Change from baseline in FeNO at each evaluation time point for each dose group.
Measured: 32 weeks
Total IgE (immunoglobulin E)
Change from baseline in total IgE at each evaluation time point for each dose group.
Measured: 32 weeks
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start12 Jan 2022
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186909
- Sponsor's protocol ID
- CM310-CSP-001
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 28 Feb 2024
- 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 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT05186909
- Acronym / sponsor ID
- CM310-CSP-001
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 11 Jan 2022 (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 II 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 24-week randomized treatment period, and a 8-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
- 3
| Arm | Type | Receives |
|---|---|---|
| CM310 300mg Q2W | Experimental | Drug: CM310CM310 is injected subcutaneously (SC) with a loading dose of 600 mg at the first dose, and then 300 mg each time, once every 2 weeks (Q2W) for a total of 12 doses. |
| CM310 150mg Q2W | Experimental | Drug: CM310CM310 is injected subcutaneously (SC) with a loading dose of 300 mg at the first dose, and then 150 mg each time, once every 2 weeks (Q2W) for a total of 12 doses. |
| Placebo | Placebo comparator | Other: PlaceboSubcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are able to understand the nature of the study and voluntarily sign the ICF.
- Diagnosed with asthma according to the 2021 version of the GINA guidelines for at least 1 year.
- Pre-bronchodilator FEV1 measurement ≤ 80% of predicted normal value.
- Subjects must have experienced a severe asthma exacerbation within 12 months prior to screening, and have not experienced a severe asthma exacerbation within 1 month prior to screening.
Key exclusion criteria (3 listed)
- Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
- Received biologics with the same therapeutic purpose within 6 months prior to screening, such as similar IL-4Rα antagonist, IL-5/5R, anti-IgE monoclonal antibody (mAb).
- Diagnosed with chronic obstructive pulmonary disease (COPD) or other lung disorders that may compromise lung function (including but not limited to idiopathic pulmonary fibrosis, allergic granulomatous angiitis, bronchopulmonary aspergillosis allergic, pulmonary tuberculosis, etc.).
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 |
|---|---|---|
| CM310CM310 Recombinant Humanized Monoclonal Antibody Injection | Drug | CM310 150mg Q2W, CM310 300mg Q2W |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
Time frame: 12 weeks
Absolute change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM310 treatment compared with placebo.
19 secondary outcomes
Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Time frame: 24 weeks
Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Time frame: 24 weeks
Annualized rate of subjects experiencing severe asthma exacerbations.
Time frame: 24 weeks
Time to the first onset of the severe asthma exacerbation event.
Time frame: 24 weeks
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).
Time frame: 24 weeks
Time to the onset of the first event of LOAC.
Time frame: 24 weeks
FEV1 percentage of predicted value (FEV1% Pred)
Time frame: 32 weeks
Peak diurnal and nocturnal expiratory flow (PEF)
Time frame: 32 weeks
Forced vital capacity (FVC)
Time frame: 32 weeks
Maximal mid-expiratory flow (MMEF)
Time frame: 32 weeks
Change from baseline of FEV1 after the use of bronchodilator.
Time frame: 32 weeks
Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point.
Time frame: 32 weeks
Change from baseline in asthma symptom score at each evaluation time point.
Time frame: 32 weeks
Incidence of Adverse events (AEs)
Time frame: 32 weeks
Trough concentration at steady-state of CM310
Time frame: 32 weeks
Human thymus and activation-regulated chemokine (TARC)
Time frame: 32 weeks
Fractional exhaled nitric oxide (FeNO).
Time frame: 32 weeks
Total IgE (immunoglobulin E)
Time frame: 32 weeks
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).
Time frame: 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM310 in people with Asthma, run by Keymed Biosciences 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks. (time frame: 12 weeks). 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 Feb 2024.