9MW1911
DrugParticipants will receive IV 9MW1911 in each dose every 28 days.
NCT Number: NCT07292714
The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety of 9MW1911 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Interested in participating?
Request Info40 year–75 year
All sexes
Interventional
Phase 2
Chizhou Central Hospital, Chizhou, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
4.Moderate-to-severe COPD with post-BD FEV1/FVC rato<0.7 and a post-BD FEV1%predicted ≥20% and<80% at screening; 5.Body Mass Index (BMI) of 16 kg/m² to 32 kg/m²; 6.Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years 7.Participants with standard of care controller therapy, for ≥3 months prior to Screening and at a stable dose of controller therapy for at least 1 month prior to the screening;
Exclusion criteria
17.With active autoimmune disease or receiving immunosuppressive therapy for an autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) are excluded.
19.received a live attenuated vaccine within 4 weeks prior to screening or during the screening period.
20.received any biologic therapy (e.g., omalizumab, dupilumab, and/or anti-interleukin-5 therapy) within 3 months prior to screening ; 21.received any investigational therapy within 3 months prior to screening or within 5 drug-elimination half-lives, whichever is longer.
22.Any clinically significant ECG abnormality deemed by the investigator to potentially affect study conduct, such as QTc prolongation (QTcF > 450 ms for males, > 470 ms for females).
23.Alanine aminotransferase (ALT) >= 2 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) >= 2 times ULN; Total bilirubin >= 1.5 times ULN.
24.Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2. 25.with any serious medical condition or clinically significant laboratory abnormality(in investigator's judgment) that could compromise the subject's safety or ability to participate in or complete the study.
27.History of severe hypersensitivity or anaphylactic reactions to any biologic agent, or known hypersensitivity to any component of the investigational drug.
29.Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
Participants will receive IV 9MW1911 in each dose every 28 days.
Participants will receive IV placebo every 28 days.
Time frame: Baseline up to week 52
Within a 52-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate.
Time frame: Weeks 0, 4, 8, 12,24,36,52
Changes in pre-bronchodilator FEV1 levels at 4, 8, 12, 24,36 and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 8, 12,24,36,52
Changes in post-bronchodilator FEV1 levels at 4, 8, 12, 24,36and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 8, 12,24,36,52
Changes in pre-brochodilator FVC levels at 4, 8, 12, 24,36 and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 8, 12,24,36,52
Changes in post-bronchodilator FVC levels at 4, 8, 12, 24,36 and 52 weeks compared to baseline.
Time frame: Baseline to week 52
Time to first moderate to severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 52.
Time frame: Baseline to week 52
Within a 52-week period, the number of severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate.
Time frame: Baseline up to week 52
Time to first severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 52.
Time frame: Weeks 0, 4, 12, 24,36,52
Changes in St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score at 4, 12, 24,36 and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 12, 24,36,52
The proportion of subjects achieving improvement of ≥4 points from baseline in the St. George's Respiratory Questionnaire for COPD (SGRQ-C) total score at Weeks 4, 12, 24, 36, and 52.
Time frame: Weeks 0, 4, 12, 24,36,52
Changes in CAT score at 4,12,24,36 and 52 weeks compared to baseline.
Time frame: 60 weeks
The incidence and severity of adverse events, adverse reactions, serious adverse events, as well as abnormal clinical laboratory test indicators, vital signs, physical examinations, and 12-lead electrocardiograms.
Time frame: 52 weeks
The incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (Nab).
Time frame: 32 weeks
Pharmacokinetics: concentrations of 9MW1911 in serum.
Time frame: 52 weeks
Serum levels of IL-33, IL-5, IL-13, and total sST2, and phosphorylated P38 (p-P38) .
Time frame: week 0
Single nucleotide polymorphism of gene rs10206753
Contact information is provided by the study sponsor or research team.
Mabwell (Shanghai) Bioscience Co., Ltd.
Industry
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate Efficacy and Safety of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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