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Moderate to Severe AsthmaPhase 2/3NCT05761028

A Study of CM310 in Subjects With Moderate to Severe Asthma

A Phase 2/3 study testing CM310 in people with Moderate to Severe Asthma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ/Ⅲ 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 12 to 75 years
Conditions the study is for
Moderate to Severe 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
600 participants
Where
1 siteChina
Study dates
28 Apr 2023to May 2032
Phase
Phase 2/3
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 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Have the ability to understand the study and voluntarily sign the informed consent form.
  • Age ≥12 and ≤75 years old, male or female, weight ≥40 kg.
  • The subject has been diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of GINA 2022.
  • Pre-bronchodilator FEV1 measured ≤ 80% of the normal predicted value at screening and baseline visits (V1 and V2).
  • A positive bronchodilation test (≥12% increase in the FEV1 post-bronchodilator and an absolute FEV1 increase of ≥200 mL) within 24 months before 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 at screening and baseline visits (V1 and V2).
  • Subjects must have experienced at least one severe asthma exacerbation event within 12 months before consent, and have not experienced a severe asthma exacerbation event within 1 month before consent, with at least one severe asthma exacerbation event occurring during treatment with medium-to-high dose ICS.
  • Subjects (including partners) have no plans to have children and voluntarily use highly effective contraception within 3 months after the last dose of study drug from the date of signing the informed consent.

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 (except for topical, ophthalmic, or intranasal corticosteroids) from 4 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: subjects with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix are eligible to enter the study if they have completed curative treatment for at least 12 months before signing the informed consent. Subjects with other malignancies are allowed to enter the study if they have completed curative treatment for at least 5 years before signing the informed consent.
  • 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>3 × 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 CM310 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. Contact the study team or a site near you to ask about taking part.

Wang Wenjuan contact

010-63942533 ext. 100036

wangwenjuan01@cspc.cn

China1 site, 1 recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijin, 100000

    Chen Wang, 010-84205288, wangchen66366@163.com

    Nan Su, 010-84206185, sunan7632@163.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ/Ⅲ 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/Ⅲ 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 52-week randomized treatment period, and a 4-week safety follow-up period.

Being tested
CM310, Placebo

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 groups in NCT05761028
Study groupRoleWhat they receive
CM310 high doseExperimentalCM310 is injected subcutaneously (SC) with a loading dose at the first dose, and then high dose thereafter, once every 2 weeks (Q2W) for a total of 26 doses.
Receives: Drug: CM310
CM310 low doseExperimentalCM310 is injected subcutaneously (SC) with a loading dose at the first dose, and then low dose thereafter, once every 2 weeks (Q2W) for a total of 26 doses.
Receives: Drug: CM310
PlaceboPlacebo comparatorSubcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 26 doses.
Receives: Other: Placebo

What is being measured

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

  1. Annualized rate of severe asthma exacerbations

    Measured: 52 weeks

Secondary outcomes (21)

  1. Change from baseline in pre-bronchodilator Forced expiratory volume in 1 second (FEV1) at Week 12

    Measured: 56 weeks

  2. Rate of change from baseline in pre-bronchodilator FEV1 at Week 12

    Measured: 56 weeks

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

    Measured: 56 weeks

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

    Measured: 56 weeks

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

    Measured: 56 weeks

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

    Measured: 56 weeks

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

    Measured: 56 weeks

  8. Annualized rate of subjects experiencing the event of loss of asthma control (LOAC)

    Measured: 52 weeks

  9. Annualized rate of severe asthma exacerbations leading to hospitalization or emergency department observation

    Measured: 52 weeks

  10. Time to the first onset of the severe asthma exacerbation event

    Measured: 52 weeks

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

    Measured: 52 weeks

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

    Measured: 56 weeks

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

    Measured: 56 weeks

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

    Measured: 56 weeks

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

    Measured: 56 weeks

  16. Incidence of Adverse events (AEs)

    Measured: 56 weeks

  17. The plasma concentration of CM310

    Measured: 56 weeks

  18. Change from baseline in human thymus and activation-regulated chemokine (TARC)

    Measured: 56 weeks

  19. Change from baseline in total IgE (immunoglobulin E)

    Measured: 56 weeks

  20. Change from baseline in fractional exhaled nitric oxide (FeNO)

    Measured: 56 weeks

  21. Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)

    Measured: 56 weeks

Timeline

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

  1. First posted9 Mar 2023
  2. Study start28 Apr 2023
  3. Primary completionMay 2032 (estimated)
  4. Study completionMay 2032 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05761028
Sponsor's protocol ID
CM310-002
Status last verified
Feb 2023
First submitted
27 Feb 2023
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CM310 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: looking for participants now, 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 combined 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.

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 Wang Wenjuan (010-63942533 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 severe asthma exacerbations (time frame: 52 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 NCT05761028.

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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