A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
- 试验地点
- 190
- 主要终点
- Number of Participants who Experience an Adverse Event (AE)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
- •Has diffuse cutaneous scleroderma
- •Has systemic sclerosis related interstitial lung disease confirmed by HRCT
- •FVC ≥ 45% of predicted normal
- •Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal
- •If on background therapy, meets stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) OR azathioprine, and corticosteroids
- •Women of childbearing potential are eligible to participate if not pregnant or breastfeeding and either willing to use an acceptable contraceptive method or sexually abstinent
- •Able to provide written informed consent and understand and comply with the requirements of the study
排除标准
- •Has an airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension
- •Has current clinical diagnosis of another inflammatory connective tissue disease
- •Has any active infections, a serious infection within the past 3 months, or chronic bacterial infection
- •Is a current smoker or smoking within 6 months of screening
- •Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study
- •Meets the protocol criteria for important laboratory exclusion criteria
研究组 & 干预措施
Tulisokibart
Tulisokibart IV administered by IV infusion
干预措施: Companion diagnostic ( CDx) (Diagnostic Test)
Placebo
Placebo administered by IV infusion
干预措施: Companion diagnostic ( CDx) (Diagnostic Test)
Placebo
Placebo administered by IV infusion
干预措施: Placebo (Drug)
Tulisokibart
Tulisokibart IV administered by IV infusion
干预措施: Tulisokibart (Drug)
结局指标
主要结局
Number of Participants who Experience an Adverse Event (AE)
时间窗: Up to Week 50
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an AE will be reported.
Number of Participants who Discontinue due to an AE
时间窗: Up to Week 50
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who discontinue due to an AE will be reported.
Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50
时间窗: Baseline and up to Week 50
FVC, as measured in milliliters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible.
Number of Participants who Experience a Serious Adverse Event (SAE)
时间窗: Up to Week 50
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an SAE will be reported.
次要结局
- Change from Baseline in FVC at Week 50(Baseline and Week 50)
- Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50(Baseline and Week 50)
- Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at Week 50(Baseline and Week 50)
- Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50(Baseline and Week 50)
- Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at Week 50(Baseline and Week 50)