EUCTR2019-002709-23-GB进行中（未招募）1 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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participants, aged 40 years or older.
- •2. Diagnosis of IPF for up to 5 years prior to screening based on ATS/ERS/JRS/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 screening
- •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 either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or post-menopausal, defined as spontaneous amenorrhea for at least 2 years
- •8. Female participants of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) and all male participants with sexual partners of childbearing potential must use highly effective methods of birth control during their participation in the study and for 90 days after the last administration of study drug. Hormonal contraceptives are not allowed. Highly effective methods of birth control are defined as those with 99% or greater efficacy.
- •9. Participants must agree to abstain from sperm or egg donation through 90 days after administration of the last dose of study drug
- •10. Able to read and sign a written informed consent form (ICF)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Receiving any non-approved agent intended for treatment of fibrosis in IPF
- •2. Forced expiratory volume during the first second (FEV1) over the forced vital capacity (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 fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (as determined by central reader)
- •7. Diagnosis of 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. Hepatic impairment or 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
- •c. Uncontrolled clinically significant arrhythmias
- •d. Significant 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
- •17. Daily use of phosphodiesterase-5 (PDE-5) inhibitor drugs (e.g., sildenafil, tadalafil, other) (Note: Intermittent use for erectile dysfunction is allowed.)
- •18. A medical or surgical condition known to affect drug absorption (e.g., major gastric surgery)
- •19. Surgical procedures planned to occur during the study period
- •20. Uncontrolled systemic arterial hypertension
- •21. Has participated in a clinical trial with an investigational agent in the 30 days prior to Screening
- •22. Likely to have lung transplantation during the study (being on transplantation list is acceptable)
- •23. Any medical condition that, in the opinion of the Investigator, may make candidates not
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