EUCTR2019-002709-23-IT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) - 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
- 84
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
- •XML File Identifier: +V1qD0rtGsgV3HMnkDCUPknYctA=
- •least 2 years
- •8. Female participants of childbearing potential (i.e., ovulating, premenopausal,
- •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 84
- •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
- •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
- •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
- •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
- •XML File Identifier: +V1qD0rtGsgV3HMnkDCUPknYctA=
- •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.)
- 另有 9 项未显示
研究者
相似试验
进行中（未招募）
1 期
A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis)Primary sclerosing cholangitis (PSC)MedDRA version: 20.1Level: LLTClassification code 10036732Term: Primary sclerosing cholangitisSystem Organ Class: 100000004871EUCTR2020-001428-33-BEPliant Therapeutics, Inc121
招募中
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 primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC)Primary Sclerosing Cholangitis (PSC) and suspected liver fibrosis10019654NL-OMON56399Pliant Therapeutics Inc.,5
进行中（未招募）
1 期
A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis)EUCTR2020-001428-33-NLPliant Therapeutics, Inc121
进行中（未招募）
1 期
A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisIdiopathic pulmonary fibrosis (IPF)MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2019-002709-23-GBPliant Therapeutics Inc.40
进行中（未招募）
1 期
A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis)EUCTR2020-001428-33-FRPliant Therapeutics, Inc84