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New treatment option for Moderate to Severe Asthma
Official title A Study of CM310 in Subjects With Moderate to Severe Asthma
ClinicalTrials.gov ID: NCT05761028
What this study is testing
What is CM310?
CM310 is an investigational medicine, given as an injectable medicine, 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 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.
- 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 12 to 75
You may be able to join if
- 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...
You likely can't join if
- 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...
- Received immune globulin or blood products within 30 days before informed consent.
- people treated with systemic corticosteroids (except for topical, ophthalmic, or intranasal corticosteroids) from 4 weeks before signing the informed...
- Received live or attenuated vaccine within 3 months before informed consent signing or planned to receive live or attenuated vaccine during the study...
- Initiation of desensitization therapy within 3 months before informed consent.
See the full eligibility criteria
Who can 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...
- Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5 at screening and baseline visits (V1 and V2).
- people 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...
- people (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.
What rules you out
- 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.
- people 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.
- 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...
- History of malignancy: people 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...
- 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...
- 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.
- people 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...
- 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...
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijin, 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, 12 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijin, 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.