A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma

NCT07372287 | Recruiting Phase 3

• 1 other identifier: CM326-004
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to severe asthma. The study consists of three periods, including an up to 4-week screening period, a 52-week double-blind randomized treatment period, and a 12-week safety follow-up period.

Conditions

Moderate to Severe Asthma

Outcome Measures

Primary Outcomes (1)

• Annualized rate of severe asthma exacerbations at Week 52

  Severe asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, or an inpatient hospitalization due to asthma. The annualized rate of severe asthma exacerbations is presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.

  week 52

Secondary Outcomes (24)

• Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52

  week 52

• Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) at Week 52

  week 52

• Annualized rate of severe asthma exacerbations associated with emergency room visit, or hospitalization at Week 52

  week 52

• Time to the first onset of the severe asthma exacerbation event

  week 52

• Time to the onset of the first event of LOAC

  week52

Study Arms (2)

CM326

EXPERIMENTAL

CM326 subcutaneous (SC)

Drug: CM326

Placebo

PLACEBO COMPARATOR

placebo, subcutaneous (SC)

Other: Placebo

Interventions

Placebo OTHER

subcutaneous injection

Placebo

CM326 DRUG

subcutaneous injection

CM326

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the study and voluntarily sign the informed consent form.
• Age ≥18 and ≤80 years old, male or female, weight ≥40 kg.
• The subject has been diagnosed with asthma for at least 1 year.
• Pre-bronchodilator FEV1 measured ≤80% of the normal predicted value.
• A positive bronchodilation test within 24 months before informed 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, Oral corticosteroids, 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.
• Asthma Control Questionnaire-5 (ACQ-6) score ≥1.5.
• Subjects must have experienced at least one severe asthma exacerbation event within 12 months before informed consent, and have not experienced a severe asthma exacerbation event within 30 days before informed consent.
• ≥ 80% compliance with usual asthma controller therapy in subjects during the screening phase
• Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.

You may not qualify if:

• Chronic obstructive pulmonary disease (COPD) without asthma or other lung disease that may impair lung function, as judged by the investigator.
• 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.
• 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.
• 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.
• 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, diabetes mellitus poorly controlled by intensive treatment.
• Active infection or acute infection requiring systemic anti-infective therapy from 4 weeks before enrollment to the time of randomization.
• A history of severe cardiovascular disease or clinically significant abnormalities identified by 12-lead electrocardiogram (ECG) during the screening phase.
• Major surgery within 8 weeks prior to informed consent requiring general anesthesia or hospitalization for \> 1 day .
• Received biological agents with the same therapeutic purpose within 4 months or 5 half-lives (whichever is longer) before signing the informed consent.
• 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.
• Received immune globulin or blood products within 30 days before informed consent.
• Subjects treated with systemic corticosteroids other than for the treatment of asthma from 8 weeks before signing the informed consent to the date of randomization.
• Received live or attenuated vaccine within 3 months before informed consent.
• Initiation of desensitization therapy within 3 months before informed consent.

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 28, 2026
• Study Start: January 23, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)