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Moderate to Severe AsthmaPhase 2NCT05774340

A Study of CM326 in Subjects With Moderate to Severe Asthma

A Phase 2 study testing CM326 in people with Moderate to Severe Asthma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 CM326 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
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
207 participants
Where
1 siteChina
Study dates
18 May 2023to Jan 2025
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

  • Have the ability to understand the study and voluntarily sign the informed consent form.
  • Age ≥18 and ≤75 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, 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-5) 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 1 month before informed consent.
  • Subjects (including partners) have no plans to have children and voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.

Who cannot join

  • Received biological agents with the same therapeutic purpose within 6 months before signing the informed consent.
  • 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.
  • 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 signing or planned to receive live or attenuated vaccine during the study period.
  • Initiation of desensitization therapy within 3 months before informed consent.
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  • 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.
  • Chronic obstructive pulmonary disease (COPD) or other lung disease that may impair lung function, as judged by the investigator.
  • Active infection or acute infection requiring systemic anti-infective therapy from 4 weeks before enrollment to the time of randomization.
  • 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, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation, or persistent arrhythmia.
  • Major surgery within 8 weeks prior to informed consent or planned surgery requiring general anesthesia or hospitalization for > 1 day during the study period.
  • Fertile women with positive pregnancy test results during screening; pregnant or lactating women.
  • Positive screening serologic test for HIV or treponema pallidum.
  • Chronic hepatitis B virus or hepatitis C virus infection.
  • Subjects with abnormal liver and kidney function, such as aspartate aminotransferase or alanine aminotransferase>2× ULN, or serum creatinine>1.5× ULN.
  • 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.
  • Allergy or intolerance to components of CM326 injection or placebo or history of severe drug allergy or anaphylactic shock.
  • 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.
  • Subjects who have used heavy alcohol within 3 months before screening.
  • History of drug abuse within 5 years before signing informed consent.
  • The investigator considers that there are any conditions that may prevent the subject from completing the study or present a significant risk to the subject or other factors that may reduce the likelihood of enrollment.

Trial locations and contacts

1 site in 1 country.

WenJuan Wang contact

+86 0311-69085587 ext. 100036

wangwenjuan01@cspc.cn

China1 site, 1 recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

    Wei Tang

    JieMing Qu

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Clinical Study to Evaluate 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 Ⅱ 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 treatment period, and a 12-week safety follow-up period.

Being tested
CM326, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM326Drug

    CM326 injection

  • PlaceboOther

    Placebo

Study groups in NCT05774340
Study groupRoleWhat they receive
CM326 Low DoseExperimentalCM326 220 mg/2 mL, subcutaneous at low dose
Receives: Drug: CM326
CM326 High DoseExperimentalCM326 220mg/2mL, subcutaneous at high dose
Receives: Drug: CM326
PlaceboPlacebo comparatorPlacebo 2mL, subcutaneous
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

Secondary outcomes (17)

  1. 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

  2. Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

    Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.

    Measured: 64 weeks

  3. Rate of change from baseline in pre-bronchodilator FEV1

    Rate of change from baseline in pre-bronchodilator FEV1 at each evaluation time point.

    Measured: 64 weeks

  4. 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: 52 weeks

  5. Time to the onset of the first event of LOAC

    Time from baseline to the onset of the first event of LOAC.

    Measured: 52 weeks

  6. Change from baseline in FEV1 percentage of predicted value (FEV1% Pred)

    Change from baseline in FEV1% Pred at each evaluation time

    Measured: 64 weeks

  7. Change from baseline in Peak diurnal and nocturnal expiratory flow (PEF)

    Change from baseline in PEF at each evaluation time

    Measured: 64 weeks

  8. Change from baseline in Forced vital capacity (FVC)

    Change from baseline in FVC at each evaluation time

    Measured: 64 weeks

  9. Change from baseline in Forced Expiratory Flow (FEF) 25-75%

    Change from baseline in 25-75%FEF at each evaluation time

    Measured: 64 weeks

  10. Change from baseline in FEV1 after the use of bronchodilator

    Change from baseline in FEV1 after the use of bronchodilator at each evaluation time

    Measured: 64 weeks

  11. Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point

    Change from baseline in the ACQ-5 score at each evaluation time point

    Measured: 64 weeks

  12. Change from baseline in asthma symptom score at each evaluation time point

    Change from baseline in asthma symptom score at each evaluation time point

    Measured: 64 weeks

  13. Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)) score at each evaluation time point

    Change from baseline in the AQLQ(S) score at each evaluation time point

    Measured: 64 weeks

  14. Change from baseline in the number of inhalations of SABA

    Change from baseline in the number of inhalations of SABA at each evaluation time

    Measured: 64 weeks

  15. Incidence of Adverse events (AEs)

    Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

    Measured: 64 weeks

  16. Pharmacokinetic profile of CM326

    Maximum Plasma Concentration（Cmax）of CM326

    Measured: 64 weeks

  17. Immunogenicity

    Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).

    Measured: 64 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start18 May 2023
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

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
207 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05774340
Sponsor's protocol ID
CM326-001
Status last verified
Mar 2023
First submitted
6 Mar 2023
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CM326 in people with Moderate to Severe Asthma, run by CSPC ZhongQi Pharmaceutical Technology 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 9 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact WenJuan Wang (+86 0311-69085587 ext. 100036, wangwenjuan01@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 subjects experiencing severe asthma exacerbations (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05774340.

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 15 Dec 2023.

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