NL-OMON54907已完成2 期
A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) - PLN-74809-IPF-202
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
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 99（—）
入选标准
- •Inclusion Criteria:
- •1. Participants, aged 40 years or older
- •2. Diagnosis of IPF for up to 5 years prior to screening based on American
- •Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese
- •Respiratory Society (JRS)/ Latin American Respiratory Society (ALAT) 2018
- •guidelines (Raghu et al, 2018)
- •Note: If IPF diagnosis is within > 3 to <= 5 years at screening, the participant
- •must have evidence of progression within the last 24 months, as defined by
- •decline in FVC percent predicted based on a relative decline of >= 5%
- •3. FVC percent of predicted >= 45%; historical FVC for entry in the study is
- •permitted if within 1 month of screening
- •4. Diffusing capacity for carbon monoxide (DLco) (hemoglobin-adjusted) >= 30%;
- •historical DLco for entry in the study is permitted if within 1 month of
- •5. Participants currently receiving treatment for IPF with nintedanib or
- •pirfenidone are allowed, provided these drugs have been given at a stable dose
- •for at least 3 months before the Screening visit and are expected to remain
- •unchanged during the study (stable dose is defined as the highest dose
- •tolerated by the participant during >= 3 months)
- •6. Estimated glomerular filtration rate >= 50 mL/min, according to the
- •Cockcroft-Gault equation
- •7. Female participants of non-childbearing potential must be surgically sterile
- •or postmenopausal
- •8. Female participants of childbearing potential must use a contraceptive
- •method with a failure rate of < 1% per year or remain abstinent (refrain from
- •heterosexual intercourse) during the treatment period and for 1 month after the
- •last dose of study treatment.
- •Male participants with female partners of childbearing potential must agree to
- •use contraceptive measures or remain abstinent (refrain from heterosexual
- •intercourse) during the treatment period and for at least 3 months after the
- •last dose of study treatment.
- •9. Participants must agree to abstain from sperm or egg donation for the
- •duration of the study, through to 3 months or 1 month, respectively, after
- •administration of the last dose of study drug.
- •10. Able to read and sign a written informed consent form (ICF)
排除标准
- •Exclusion Criteria:
- •1. Receiving any nonapproved agent intended for treatment of fibrosis in IPF
- •2. Forced expiratory volume during the first second (FEV1) over the FVC ratio
- •(FEV1/FVC ratio) < 0.7 at screening
- •3. Clinical evidence of active infection, including but not limited to
- •bronchitis, pneumonia, or sinusitis that can affect FVC measurement during
- •screening or at randomization
- •4. Any other condition that prevents the correct assessment of spirometry
- •performance (for example a broken rib or chest pain of other origin that
- •prevents adequate forced breathing)
- •5. Known acute IPF exacerbation or suspicion by the Investigator of such,
- •within 6 months of screening
- •6. The extent of emphysema is greater than the extent of fibrotic changes on
- •the most recent high-resolution computerized tomography (HRCT) scan (as
- •determined by central reader); a) HRCT scan performed within 2 years of the
- •screening date may be used
- •7. Severe pulmonary hypertension
- •8. Smoking of any kind (not limited to tobacco) within 3 months of screening or
- •unwilling to avoid smoking throughout the study
- •9. Lower respiratory tract infection requiring antibiotics within 4 weeks prior
- •to screening and/or during the screening period
- •10. History of malignancy within the past 5 years or ongoing malignancy other
- •than basal cell carcinoma, resected noninvasive cutaneous squamous cell
- •carcinoma, or treated cervical carcinoma in situ
- •11. End-stage liver disease
- •12. Renal impairment or end-stage kidney disease requiring dialysis
- •13. History of unstable or deteriorating cardiac or pulmonary disease (other
- •than IPF) within the 6 months prior to screening, including but not limited to
- •the following:
- •a. Unstable angina pectoris or myocardial infarction
- •b. Congestive heart failure requiring hospitalization during the 6 months prior
- •to screening
- •c. Uncontrolled clinically significant arrhythmias (e.g., potentially resulting
- •in health care utilization or hospitalization)
- •d. Any clinically relevant electrocardiogram (ECG) abnormalities, including but
- •not limited to, QT interval corrected for heart rate using Fridericia's formula
- •(QTcF) > 450 msec for males or > 460 msec for females at the Screening visit
- •(including Day -1) or prior to administration of the initial dose of study drug.
- •14. Any of the following liver function test criteria above specified limits:
- •total bilirubin > 1.5 × the upper limit of normal (ULN); aspartate
- •aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × ULN; alkaline
- •phosphatase > 2.5 × ULN.
- •Note: participants currently receiving nintedanib or pirfenidone as IPF SoC
- •treatment, who have previously presented any liver function test elevations
- •associated with nintedanib or pirfenidone treatment greater than that described
- •above or resulting in dose reduction, treatment interruption, or
- •discontinuation are not eligible.
- •15. Any of the following at screening: hemoglobin < 10.0 g/dL, or neutrophils <
- •1500 /mm3, or platelets < 100,000 /mL
- •16. Pregnant or lactating females
- 另有 5 项未显示
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