NCT07725939招募中2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis (SCALA)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 402
- 试验地点
- 7
- 主要终点
- Time from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
研究概览
简要总结
The purpose of the study is to investigate the efficacy of galvokimig versus placebo in the time to the first acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in study participants with moderate-to-severe COPD with chronic bronchitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be aged ≥40 to ≤80 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
- •Participant with a documented physician-diagnosed moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis phenotype
- •Participant has a documented record of receiving maintenance inhaled therapy at a stable dose for ≥3 months prior to Screening comprised of:
- •long-acting beta2 agonist (LABA) +long-acting muscarinic antagonist (LAMA) ±inhaled corticosteroid (ICS)
- •Participant at a high risk of exacerbations, defined as a documented exacerbation history of ≥2 moderate or severe acute exacerbation(s) of chronic obstructive pulmonary disease (AECOPD) in the 12 months prior to Screening or 1 severe AECOPD in the 6 months prior to Screening
- •Participant has a Chronic Airways Assessment Test (CAAT) score of ≥15 at Screening
- •Participant has acceptable inhaler and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit
- •Participant can be male or female.
- •A male participant must agree to use contraception during the Intervention Periods and for at least 60 days after the final dose of study intervention and refrain from donating sperm during this period
- •A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies:
- •Not a women of childbearing potential (WOCBP) OR
- •A WOCBP who agrees to follow the contraceptive guidance during the Intervention Periods and for at least 60 days after the final dose of study intervention
- •Participant is a current or ex-smoker (with tobacco smoking history of ≥10 pack-years)
排除标准
- •Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study
- •Participant has a history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new onset ischemic heart disease or in the opinion of the investigator other serious cardiac disease, within 12 months prior to Screening
- •Participant has a presence or a family history (first degree) of inflammatory bowel disease (IBD)
- •Participant has uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicidal behavior
- •Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within the 6 months prior to Baseline
- •Participant has clinically important pulmonary disease other than COPD with chronic bronchitis
- •Participant has hypercapnia requiring bilevel positive airway pressure (BiPAP)
- •Participant has had a live or attenuated vaccines within 4 weeks prior to Screening or plans to receive such vaccines during the study
- •Participant has relevant safety events to one or more interleukin (IL)-13 or IL-17 biologic response modifiers that resulted in discontinuation and change of treatment
- •Participant has absolute neutrophil count (ANC) <1.5 × 10³/μL
- •Participant has a corrected QT interval (QTc) >450msec for male participants or QTc >470msec for female participants or QTc >480 msec in participants with bundle branch block
- •Participant has a history of past or current chronic alcohol or drug abuse within the previous 12 months
研究组 & 干预措施
Galvokimig Dose 1 Arm
Experimental
Participants randomly assigned to this arm will receive a predefined Galvokimig Dose.
干预措施: Galvokimig (Biological)
Galvokimig Dose 2 Arm
Experimental
Participants randomly assigned to this arm will receive a predefined Galvokimig Dose.
干预措施: Galvokimig (Biological)
Placebo Arm
Placebo Comparator
Participants randomly assigned to this arm will receive a matching Placebo.
干预措施: Placebo (Biological)
结局指标
主要结局
Time from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
时间窗: Up to Week 60
AECOPD will be defined as a worsening in the study participants' usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days (or less if the worsening is so rapid and profound that the treating physician judges that intensification of treatment cannot be delayed). Moderate AECOPD require use of systemic corticosteroids and/or antibiotics for at least 3 consecutive days; Severe AECOPD is an AECOPD requiring a hospitalization for \>= 24 hours or leading to a COPD-related death.
次要结局
- Pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at 24 weeks(At Week 24)
- Annualized rate of moderate and severe AECOPD up to End of Treatment(From Baseline up to Week 52)
- Change from Baseline at Week 24 in St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C)(At Week 24)
- Proportion of participants with a decrease in SGRQ C total score of ≥4 points from Baseline to Week 24(From Baseline up to Week 24)
- Incidence of Treatment-Emergent (TE) Adverse Events (AE)(Up to Week 60)
- Incidence of TE Serious Adverse Events (SAEs)(Up to Week 60)
研究者
研究点 (7)
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