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New treatment option for Asthma
Official title Study of CM512 Injection in Subjects With Moderate-to-severe Asthma
ClinicalTrials.gov ID: NCT07011524
What this study is testing
What is CM512 injection?
CM512 injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for 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 multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with moderate-to-severe asthma.
- Phase 2: a mid-size study of how well it works
- 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 18 to 75
You may be able to join if
- Able to understand and comply with procedures of the protocol, and voluntarily sign the Informed Consent Form.
- Age ≥ 18 years old and ≤ 75 years old.
- Body mass index (BMI) ≥ 18.0 kg/(m\ m).
- Documented treatment with medium to high dose Inhaled Corticosteroids (ICS) in combination with asthma controller medication for at least 3 months...
- Documented history of at least 1 severe asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the...
You likely can't join if
- Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
- With a history of drug abuse within the past 5 years before screening visit.
- Allergic or intolerant to CM512 injection or placebo components, or with a history of severe drug allergies or anaphylactic shock.
- With any medical or non-medical conditions that are not suitable for participation in this study by investigators.
See the full eligibility criteria
- Able to understand and comply with procedures of the protocol, and voluntarily sign the Informed Consent Form.
- Age ≥ 18 years old and ≤ 75 years old.
- Body mass index (BMI) ≥ 18.0 kg/(m\ m).
- Documented treatment with medium to high dose Inhaled Corticosteroids (ICS) in combination with asthma controller medication for at least 3 months with a stable dose ≥1 month prior to Visit 1.
- Documented history of at least 1 severe asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
- Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5
- Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
- With a history of drug abuse within the past 5 years before screening visit.
- Allergic or intolerant to CM512 injection or placebo components, or with a history of severe drug allergies or anaphylactic shock.
- With any medical or non-medical conditions that are not suitable for participation in this study by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.