CM512 injection for adults with moderate-to-severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled phase II trial of CM512 in adults with moderate-to-severe asthma. Eligible participants are adults on medium-to-high dose inhaled corticosteroids plus controller therapy with a recent history of severe exacerbation and an ACQ-6 score ≥1.5. Participants will be randomized to receive CM512 injection or placebo and followed for clinical outcomes, safety events, and changes in asthma control. Blood samples will be collected for pharmacokinetics, pharmacodynamics, and immunogenicity testing during scheduled visits.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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.

Where it's running

• The First Clinical Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Ruchong Chen — The First Clinical Hospital of Guangzhou Medical University
• Study coordinator: Qian Jia
• Email: qianjia@keymedbio.com
• Phone: 028-88610620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.