NCT04064242已完成2 期
A Subject and Investigator Blinded, Randomized, Placebo-controlled, Repeat-dose, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of CMK389 in Patients With Chronic 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
- 62
- 试验地点
- 7
- 主要终点
- Change in Percent Predicted FVC From Baseline to 16 Weeks of Treatment
研究概览
简要总结
The purpose of this proof of concept study was to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.
详细描述
This was a subject and investigator blinded, randomized, placebo-controlled, parallel-group, repeat-dose, multicenter, non-confirmatory study of CMK389 in chronic pulmonary sarcoidosis. This study investigated the safety and efficacy of 10 mg/kg CMK389 administered intravenously (i.v.) every 4 weeks for a total of 4 doses, versus placebo
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a body mass index (BMI) at screening within the range of 18 - 46 kg/m
- •BMI = Body weight (kg) / [Height (m)]2
- •Biopsy proven pulmonary sarcoidosis diagnosed > 1 year prior to screening
- •Scadding stage II, III or IV as determined by the most recent chest x-ray obtained within 12 months prior to screening or at screening (confirmed by the Investigator)
- •HRCT extent of fibrosis <20% (confirmed by the central imaging reader) at screening
- •Treatment with 5-15 mg/day prednisone (or prednisone oral equivalents) for ≥ 6 months prior to screening.
- •Co-medication with methotrexate or azathioprine for ≥ 6 months prior to screening (Note: hydroxychloroquine is allowed as background therapy but not required)
- •Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
排除标准
- •Diagnosis of significant pulmonary hypertension (WHO group 5) requiring pharmacological treatment
- •Active cardiac sarcoidosis requiring treatment. Inactive cardiac sarcoidosis or stable cardiac sarcoidosis not requiring treatment are permissible.
- •A known diagnosis of neurosarcoidosis
- •Forced vital capacity (FVC) <50% of predicted at screening (central read)
- •Modified British Medical Research Council (mMRC) dyspnea scale ≥ 3 at screening
- •Concomitant treatment with leflunomide, cyclophosphamide, mycophenolate, infliximab, etanercept, adalimumab, golimumab, ustekinumab, roflumilast, pentoxifylline, and abatacept within 12 weeks of screening
- •Prior treatment with rituximab, canakinumab, anakinra, and tocilizumab
- •Current use of any inhaled substance, including but not limited to tobacco, marijuana products and use of electronic cigarette or vaping device, and excluding inhalers or nebulizers prescribed for pulmonary sarcoidosis
- •Any conditions or significant medical problems which in the opinion of the investigator and in consultation with the sponsor, immunocompromises the patient and/or places the patient at unacceptable risk for immunomodulatory therapy
- •Contraindication to FDG-PET scan investigations such as severe claustrophobia or uncontrolled diabetes
- •History or current diagnosis of ECG abnormalities not due to Cardiac Sarcoidosis and indicating significant risk of safety for patients participating in the study
- •A diagnosis of Lofgren's syndrome
- •A history of pancreatitis
研究组 & 干预措施
CMK389
Experimental
CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses
干预措施: CMK389 (Drug)
Placebo
Placebo Comparator
Placebo i.v. every 4 weeks for a total of 4 doses
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Percent Predicted FVC From Baseline to 16 Weeks of Treatment
时间窗: Baseline, Week 16
To assess the effect of CMK389 compared to placebo after 16 weeks of treatment on spirometry (Forced Vital Capacity). Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Percent predicted FVC is the percentage of the age, height and gender adjusted predicted value.
次要结局
- Number of Participants Who Had an Increase in Steroid Usage From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
- Number of Participants Who Deteriorate From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
- Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
- The Observed Serum Concentration Following CMK389 Administration at End of Infusion(Post 1 hour: Day 1, Day 29, Day 57, Day 85)
- Pre-dose Trough Concentration (Ctrough) of CMK389(Pre-dose: Day 1, Day 29, Day 57, Day 85)
- Change in FEV1 From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
- Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
- Change in 6-minute Walk Distance (6MWD) From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
研究者
研究点 (7)
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