NCT02888080已完成2 期
A Multiple-dose, Subject and Investigator Blinded, Placebo-controlled, Parallel Design Study to Assess the Efficacy, Safety and Tolerability of ACZ885(Canakinumab) in Patients With Pulmonary Sarcoidosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry
研究概览
简要总结
The purpose of this study is to assess if ACZ885 will improve lung function in association with reduction of tissue inflammation in patients with chronic sarcoidosis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ages 18 to 80 years of age (both inclusive)
- •Pulmonary sarcoidosis disease duration of ≥1 year
- •Clinically active disease demonstrated either by a biopsy (any organ) or by bronchoalevolar lavage (lymphocytosis >15%, CD4+/CD8+ ration>3.5, CD103+/CD4+/CD4+ ratio <0.2). Patients must also have all of the following criteria:
- •MMRC dyspnea scale ≥1
- •Threshold FVC 50 - 90% of predicted
- •Evidence of parenchymal lung involvement by HRCT at screening or by historical radiological evidence (e.g. CT, MRI or x-ray)
排除标准
- •Treated pulmonary hypertension
- •Previous exposure to concomitant treatment according to the following criteria:
- •Prednisone >15 mg/day or changes in prednisone dose in the 8 weeks prior to screening
- •More than one immune-modulator (i.e., methotrexate, azathioprine, leflunomide, hydroxychloroquine) or changes in their dosing levels within 12 weeks of randomization.
- •Mycophenolate use within 12 weeks of randomization
- •Prior treatment with any biologic drug targeting the immune system within 180 days of randomization or history of any previous use of rituximab
- •History of bleeding disorder
- •Forced vital capacity (FVC) <50% of predicted
- •Extra-pulmonary sarcoidosis as primary treatment indication (e.g., involving brain, heart, eye and renal disease with significant hypercalcemia)
- •Any conditions or significant medical problems which in the opinion of the investigator immune-compromise the patient and/or places the patient at unacceptable risk for immunomodulatory therapy, such as:
- •Absolute neutrophil count (ANC) <LLN (1,500/μl)
- •Thrombocytopenia CTCAE v4.03 Grade 1: Platelets <LLN (75.0 x 10exp9/L)
- •Any active or recurrent bacterial, fungal (with exception of onychomycosis) or viral infection
- •Presence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infections based on screening lab results
- •Presence of active or latent tuberculosis (Tb). If historical Tb result is available, Tb status needs to be confirmed pre-randomization as determined by screening laboratory measurements.
- •Clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty's syndrome
- •Live vaccinations within 3 months prior to the start of the trial
- •Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the patient unsuitable for the trial
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception defined in the protocol for the study.
研究组 & 干预措施
ACZ885
Experimental
ACZ885 (300 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.
干预措施: ACZ885 (Drug)
Placebo
Placebo Comparator
Placebo (0 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry
时间窗: Baseline, Week 24
To compare the effect of ACZ885 versus placebo in the change between baseline and week 24 in pulmonary function as measured by spirometry (Predicted Forced Vital Capacity).
次要结局
- Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT(Baseline, Week 12)
- Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT(Baseline, Week 12)
- Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT(Baseline, Week 12)
- Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)(Baseline, week 24)
- Change From Baseline in High Resolution Computed Tomography (HRCT) Scoring(Baseline, Week 24)
- Change From Baseline Distance Walked as Assessed by the 6-minute Walk Test(Baseline, Week 12, and Week 24)
- Change From Baseline of Additional [F-18]FDG-PET Outcomes(Baseline, Week 12)
- Change From Baseline in Other Parameters of Pulmonary Function Testing : Diffusion Capacity of Lung for CO(Baseline, week 24)
- Change From Baseline in Other Parameters of Pulmonary Function Testing : Percent Predicted DLco, FEV1/FVC, FEV3/FVC, Percent Predicted Forced Expiratory Flow (FEF) 25-75, RV/TLC (Residual Volume /Total Lung Capacity)(Baseline, week 24)
研究者
研究点 (1)
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