NCT05722964已完成2 期
Efficacy and Safety of Intravenous Infusion of SHR-1906 in Patients With Idiopathic Pulmonary Fibrosis: a Multicenter, Randomized, Double-blind, Parallel Placebo-controlled Phase II Trial
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24
研究概览
简要总结
To evaluate the efficacy and safety of intravenous SHR-1906 in the treatment of idiopathic pulmonary fibrosis. The study is divided into four stages: screening period, baseline period, treatment period and safe follow-up period. It is planned that 108 patients will be randomly assigned to the following three treatment groups for treatment
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
- •Age 40 to 80, inclusive, at the time of screening；
- •IPF diagnosed according to ATS/ERS/JRS/ALAT guidelines (2022) (HRCT diagnosis UIP type/possible UIP type (standard HRCT confirmed by central review in recent 3 months) with or without pathological UIP type/possible UIP type (pathology refers to frozen lung biopsy or surgical/thoracoscopic lung biopsy)；
- •90% ≥ FVCpp ≥ 45% during screening period and the first day;
- •The percent of predicted DLCO value (corrected by Hb value) at screening is ≥ 30% and ≤ 90%;
- •Before the screening period, pirfenidone or nidanib with stable dose ≥ 8 weeks (pirfenidone ≥ 1200 mg/denidanib ≥ 200 mg/d) can continue to maintain treatment with stable dose during the study period; Or at least 4 weeks before the screening period, pirfenidone or nidanib was not used (pirfenidone or nidanib was refused due to intolerance or various factors) ；
排除标准
- •Evidence of any of the following significant obstructive pulmonary disease: (1) The ratio of forced expiratory volume/forced vital capacity (FEV1/FVC) at the first second is < 0.70 (after using bronchodilator) or (2) HRCT shows that emphysema is greater than fibrosis;
- •Interstitial lung diseases (ILD) other than IPF include but are not limited to: any other type of idiopathic interstitial pneumonia; Lung diseases related to contact with fibroblasts or other environmental toxins or drugs; Other types of occupational lung diseases; Granulomatous lung disease; Pulmonary vascular disease; Systemic diseases include vasculitis infectious diseases (i.e. Tuberculosis) and connective tissue diseases If the diagnosis is unclear, serological examination and/or multidisciplinary expert group review should be conducted to confirm IPF or other types of ILD diagnosis;
- •A history of other types of respiratory diseases, including respiratory tract, lung parenchyma, pleural cavity, mediastinum, diaphragm or chest wall diseases or disorders, such as acute respiratory infection, active tuberculosis, etc., which researchers believe will affect the primary endpoint of the study or otherwise affect the participation of subjects in the study;
研究组 & 干预措施
SHR-1906，- Dose B
Experimental
干预措施: SHR-1906 (Drug)
SHR-1906，-Dose A
Experimental
干预措施: SHR-1906 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24
时间窗: Baseline, Week 24
次要结局
- Change from Baseline in FVC (L) to Week 4, 8, 12, 16, 20, 24(Baseline, Week 4, 8, 12, 16, 20, 24)
- Change from Baseline in FVC% (Percent of Predicted FVC value) to Week 4, 8, 12, 16, 20(Baseline, Week 4, 8, 12, 16, 20)
- All-cause mortality(Start of Treatment to end of study (approximately 28 weeks))
- Adverse events(Start of Treatment to end of study (approximately 28 weeks))
- Serum concentration of SHR-1906(Start of Treatment to end of study (approximately 28 weeks))
- Proportion of anti-SHR-1906 antibody (ADA) formed during the study from baseline(Start of Treatment to end of study (approximately 28 weeks))
- Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) to Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Scores to Week 12 and Week 24(Baseline, Week 12 and Week 24])
- Number of Praticipants with an Acute Exacerbation of IPF(Start of Treatment to end of study (approximately 28 weeks))
研究者
研究点 (1)
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