A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country207 target enrollmentMay 18, 2023

ConditionsModerate to Severe Asthma

InterventionsCM326 Placebo

Overview

Phase: Phase 2
Intervention: CM326
Conditions: Moderate to Severe Asthma
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 207
Locations: 1
Primary Endpoint: Annualized rate of subjects experiencing severe asthma exacerbations
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ 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 treatment period, and a 12-week safety follow-up period.

Registry

clinicaltrials.gov

Start Date

May 18, 2023

End Date

January 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have the ability to understand the study and voluntarily sign the informed consent form.
•Age ≥18 and ≤75 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, 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-5) score ≥1.
•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 1 month before informed consent.
•Subjects (including partners) have no plans to have children and voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.

Exclusion Criteria

•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.
•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 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.

Arms & Interventions

CM326 Low Dose

CM326 220 mg/2 mL, subcutaneous at low dose

Intervention: CM326

CM326 High Dose

CM326 220mg/2mL, subcutaneous at high dose

Intervention: CM326

Placebo

Placebo 2mL, subcutaneous

Intervention: Placebo

Outcomes

Primary Outcomes

Annualized rate of subjects experiencing severe asthma exacerbations

Time Frame: 24 weeks

Annualized rate of subjects experiencing severe asthma exacerbations during the 24-week randomized treatment period.

Secondary Outcomes

Change from baseline in the number of inhalations of SABA(64 weeks)
Immunogenicity(64 weeks)
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)(64 weeks)
Rate of change from baseline in pre-bronchodilator FEV1(64 weeks)
Time to the first onset of the severe asthma exacerbation event(52 weeks)
Time to the onset of the first event of LOAC(52 weeks)
Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)) score at each evaluation time point(64 weeks)
Incidence of Adverse events (AEs)(64 weeks)
Change from baseline in asthma symptom score at each evaluation time point(64 weeks)
Change from baseline in Forced vital capacity (FVC)(64 weeks)
Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point(64 weeks)
Change from baseline in FEV1 after the use of bronchodilator(64 weeks)
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC)(24 weeks)
Change from baseline in Peak diurnal and nocturnal expiratory flow (PEF)(64 weeks)
Pharmacokinetic profile of CM326(64 weeks)
Change from baseline in FEV1 percentage of predicted value (FEV1% Pred)(64 weeks)
Change from baseline in Forced Expiratory Flow (FEF) 25-75%(64 weeks)