A Study of CM326 in Subjects With Moderate to Severe Asthma

NCT05774340 | Unknown Phase 2

• 1 other identifier: CM326-001
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Asthma

Outcome Measures

Primary Outcomes (1)

• Annualized rate of subjects experiencing severe asthma exacerbations

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

  24 weeks

Secondary Outcomes (17)

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

  24 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

Study Arms (3)

CM326 Low Dose

EXPERIMENTAL

CM326 220 mg/2 mL, subcutaneous at low dose

Drug: CM326

CM326 High Dose

EXPERIMENTAL

CM326 220mg/2mL, subcutaneous at high dose

Drug: CM326

Placebo

PLACEBO COMPARATOR

Placebo 2mL, subcutaneous

Other: Placebo

Interventions

CM326 DRUG

CM326 injection

CM326 High Dose; CM326 Low Dose

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥1.5.
• 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 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.

You may not qualify if:

• 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.
• 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, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation, or persistent arrhythmia.
• Major surgery within 8 weeks prior to informed consent or planned surgery requiring general anesthesia or hospitalization for \> 1 day during the study period.
• Fertile women with positive pregnancy test results during screening; pregnant or lactating women.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Central Study Contacts

WenJuan Wang

CONTACT

+86 0311-69085587; wangwenjuan01@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: May 18, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-03

Locations

CN (1)