NCT05483907已完成2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, 24-Week Study to Evaluate the Efficacy, Safety, and Tolerability of BBT-877, as Mono- or add-on Therapy, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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
- 129
- 试验地点
- 44
- 主要终点
- In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo
研究概览
简要总结
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of 200 mg twice daily (BID) of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male patients who have completed family planning or female patient, aged 40 years or older
- •Diagnosis of IPF in accordance with American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines for diagnosis in effect at the time of screening
- •Chest high-resolution computed tomography (HRCT) performed according to ATS guidelines within 12 months prior to screening and according to minimum requirements for IPF diagnosis by central review based on HRCT and lung biopsy. If no historical acceptable HRCT is available prior to screening, an HRCT can be performed during screening. In both cases, a central reading of the HRCT has to be done as well as a review of lung biopsy slides, if available and potentially supportive for diagnosis.
- •Able to walk at least 150 meters during the 6MWT at screening
- •Resting oxygen saturation of ≥89% using a maximum of 6 L/min of supplemental oxygen at sea level, and up to 8 L/min at altitude during screening
- •FVC ≥45% predicted of normal
- •Ratio of forced expiratory volume in the first second (FEV1) to FVC ≥0.7
- •Diffusing capacity for the DLCO corrected for hemoglobin ≥30% predicted of normal
- •Absence of IPF improvement in the past year, as determined by the investigator
- •Patients receiving either pirfenidone or nintedanib, should be on it for at least 3 months and with a stable dose in the 4 weeks prior to screening, OR taking neither pirfenidone
排除标准
- •Unable to perform spirometry as per ATS
- •Evidence of IPF exacerbation within 3 months prior to and/or during screening
- •Evidence of emphysema extent greater than the extent of fibrosis
- •Current smoker (tobacco, e-cigarette)
- •History of lung transplant or lung volume reduction surgery
- •Current immunosuppressive condition
- •Estimated life expectancy of less than 12 months or 30 months in the opinion of the investigator
- •Congestive heart failure class III or IV according to New-York Heart Association classification
- •Pulmonary hypertension (PH) requiring PH specific therapy
- •Unstable cardiovascular, pulmonary or other disease within 6 months prior to screening or during the screening period
- •Use of other medications likely to interfere with study assessments
- •Any other current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results
研究组 & 干预措施
BBT-877
Experimental
200 mg twice daily (BID)of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
干预措施: BBT-877 (Drug)
Placebo
Placebo Comparator
200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
干预措施: Placebo (Drug)
结局指标
主要结局
In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo
时间窗: After 24 weeks of treatment
Change from baseline in FVC (in mL).
次要结局
- In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo(After 24 weeks of treatment)
- To assess the change in IPF impacts from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo(after 24 weeks of treatment)
- To evaluate the effect of on diffusing capacity of lung for carbon monoxide (DLCO) of BBT-877 compared to placebo(After 24 weeks of treatment)
- To assess the change in IPF symptoms from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo(after 24 weeks of treatment)
- To assess the safety of BBT-877 compared to placebo(over 24 weeks)
- To evaluate the effect on functional exercise capacity (measured by the 6-Minute Walk Test [6MWT]) of BBT-877 compared to placebo(After 24 weeks of treatment)
- To evaluate potential effect of BBT-877 on pharmacokinetics (PK)of each antifibrotic(AF)in patients with IPF(0, 4, 12, 24 weeks of treatment)
- To evaluate the potential effect of each AF on PK of BBT-877 in patients with IPF(0, 4, 12, 24 weeks of treatment)
研究者
研究点 (44)
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