CTIS2023-506185-31-00进行中(未招募)1 期
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF) - PLN-74809-IPF-206
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 769
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+(—)
- 性别
- All
入选标准
- •1. = 40 years of age prior to screening, 2. IPF diagnosis = 7 years prior to screening based upon American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Association 2018 guidelines and confirmed with central review (Raghu et al 2018). A HRCT scan performed = 2 years may be used for eligibility., 3. FVCpp = 45%, 4. Diffusing capacity for carbon monoxide percent predicted (DLCOpp) (hemoglobin-adjusted) = 30% and < 90%, 5. Current treatment for IPF with background therapy is allowed, if at a stable dose for = 12 weeks prior to screening
排除标准
- •1. Receiving pharmacologic therapy for pulmonary hypertension, 2. Forced expiratory volume in the FEV1/FVC ratio < 0.7 at screening
研究者
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