CM512 injection for adults with moderate-to-severe asthma

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With Moderate-to-severe Asthma.

This will test whether CM512 injections help adults with moderate-to-severe asthma control symptoms better than a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Keymed Biosciences Co.Ltd (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07011524 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with moderate-to-severe asthma who are on medium-to-high dose inhaled corticosteroids plus controller therapy, have had at least one severe exacerbation in the past 12 months, and have an ACQ-6 score ≥1.5 are ideal candidates.

Not a fit: Patients who are pregnant or breastfeeding, allergic to CM512 components, have a recent history of drug abuse, or who have only mild asthma not requiring medium-to-high dose ICS are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, CM512 could improve asthma control and reduce the frequency or severity of exacerbations for people with moderate-to-severe disease.

How similar studies have performed: Other injectable biologic therapies targeting inflammatory pathways in moderate-to-severe asthma (for example anti-IgE and anti-IL-5 agents) have shown clinical benefit, but CM512 itself is a novel agent and its effects are unproven.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• 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

Conditions Asthma