Nerandomilast Added to Mycophenolate for Treatment of Pulmonary Fibrosis (NERAM-PF).
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pulmonary fibrosis
研究概览
简要总结
This is a trial designed to evaluate the combination of nerandomilast with mycophenolate across a wide variety of pulmonary fibrosis subtypes, with the aim of providing clinicians with assurance that this is an appropriate therapeutic combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Any underlying pulmonary fibrosis diagnosis (excluding IPF) with ≥ 10% fibrosis on chest HRCT (performed within 1 year of screening) by volume assessment as determined by the treating physician
- •Anticipated benefit from nerandomilast therapy as determined by the treating physician (note that previous observed progression as defined in previous PPF clinical trials is not required prior to enrolment)
- •Stable dose of mycophenolate for the preceding 3 months, with a minimum total daily dose of 1,500mg for mycophenolate mofetil or 1080mg for mycophenolate sodium
- •Clinically stable for the preceding 6 weeks (did not require addition of corticosteroids for AE-ILD, or any other reason for urgent hospitalization).
排除标准
- •Diagnosis of IPF
- •Contraindication to treatment with nerandomilast as determined by the treating physician
- •FVC < 45% or DLCO < 25% based on last PFT (must be performed within 3 months of screening)
- •Use of systemic prednisone > 10 mg/day for > 2 weeks within 3 months of screening (initiation of prednisone during the study is permitted if considered clinically indicated in the opinion of the treating physician)
- •Use of azathioprine, cyclophosphamide, rituximab, and/or tocilizumab within 3 months of screening (initiation of azathioprine, cyclophosphamide, rituximab, and/or tocilizumab during the study is permitted if considered clinically indicated in the opinion of the treating physician)
- •Use of pirfenidone and/or nintedanib within 6 weeks of screening (initiation of nintedanib and/or pirfenidone during the study is permitted if considered clinically indicated in the opinion of the treating physician)
- •Significant emphysema (> 10% volume on HRCT or FEV1/FVC < lower limit of normal)
- •Expected survival < 6 months as determined by the treating physician
研究组 & 干预措施
Participants already receiving treatment with mycophenolate
干预措施: Nerandomilast 18 mg - adult formulation (Drug)
结局指标
主要结局
Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pulmonary fibrosis
时间窗: Four months
The primary outcome will be the frequency of persistent nerandomilast use at 4 months, recorded as a dichotomous variable. To account for the proportion of patients with persisting use of nerandomilast at 4 months after baseline, the percentage of days treated will be recorderd based on patient report and verified against drug dispensation records and 4-month pill counts. Pre-specified analyses will include evaluation of rate of discontinuation of nerandomilast across specific variables, including age, sex, body weight, total daily dose of mycophenolate, and total daily dose of mycophenolate adjusted for body weight. This outcome will support the main hypothesis that, when combined with mycophenolate, nerandomilast will achieve a persistency of ≥ 80% ongoing use at 4 months
次要结局
- Determine the frequency of adverse events associated with nerandomilast(Four months)
- Compare rate of change in forced vital capacity (FVC) in patients treated with nerandomilast to pre-treatment rate of change(Four months)
- Compare rate of change in diffusion capacity of the lung for carbon monoxide (DLCO) in patients treated with nerandomilast to pre-treatment rate of change(Four months)
- Determine the rate of change in patient-reported outcome measures (PROMs) from baseline to month 4(Four months)
研究者
Chrisopher Ryerson
Christopher J. Ryerson, Professor, Department of Medicine, University of British Columbia; Director, Interstitial Lung Disease Program, St. Paul's Hospital; Head, Division of Respiratory Medicine, Providence Health Care
University of British Columbia