NL-OMON53568已完成2 期
A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis - HZNP-HZN-825-303
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
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
- •Core phase:
- •1. Written informed consent.
- •2. Male or female >=18 years of age at Screening.
- •3. Current diagnosis of IPF, as defined by American Thoracic Society
- •(ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society
- •(JRS)/Latin American Thoracic Society (ALAT) guidelines [Raghu et al., 2022]
- •and determined by central review; the date of initial diagnosis of IPF should
- •be <=7 years prior to Screening.
- •4. No recent changes or planned changes to the dose or regimen for IPF therapy,
- •defined as:
- •Receiving a stable dose of IPF-approved therapy (i.e., nintedanib or
- •pirfenidone) for a minimum of 3 months prior to Day 1 with no plans to change
- •the background regimen during trial participation, or
- •Not currently receiving background IPF-approved therapy at Screening (either
- •naïve to IPF-approved therapy or previously discontinued any IPF-approved
- •therapy at least 4 weeks prior to Day 1 or drug-specific, 5 half-lives
- •elimination period if longer than 4 weeks), and with no current plans to
- •restart treatment during trial participation
- •Subjects receiving any additional agent for IPF therapy must be on a stable
- •regimen for at least 3 months prior to Day 1 with no current plans to change
- •the treatment regimen during trial participation. Any previously discontinued
- •therapy used to treat IPF must have been discontinued at least 4 weeks prior to
- •Day 1 or 5 half-lives for that specific therapy must have elapsed, whichever is
- •longer, with no plans to restart the therapy during trial participation.
- •5. Lung HRCT historically performed within 6 months prior to the Screening
- •Visit and according to the minimum requirements for IPF diagnosis by central
- •review based on subject's HRCT. If an evaluable HRCT is not available within 6
- •months prior to Screening, an HRCT will be performed at Screening to determine
- •eligibility, according to the same requirements as the historical HRCT. The
- •HRCT must demonstrate a usual interstitial pneumonia or probable usual
- •interstitial pneumonia pattern based on central review vendor interpretation.
- •Histopathology in combination with HRCT results supportive of an IPF or IPF
- •likely diagnosis according to Raghu et al., 2022 can be submitted to support
- •subject eligibility.
- •6. HRCT shows >=10% to <50% parenchymal fibrosis (reticulation) and the extent
- •of fibrotic changes is greater than the extent of emphysema on the most recent
- •HRCT scan (central reviewer determined).
- •7. Meets all of the following criteria during the Screening Period, as
- •determined by central review:
- •a. FVC >=45% predicted of normal
- •b. forced expiratory volume in 1 second (FEV1)/FVC >=0.7
- •c. DLCO corrected for hemoglobin is >=25% and <=90% predicted of normal
- •8. Estimated minimum life expectancy of >=30 months for non-IPF-related disease,
- •in the opinion of the Investigator.
- •9. Vaccinations are up to date, according to the Investigator*s discretion,
- •given age, comorbidities and local availability prior to trial drug dosing.
- •10. Willing and able to comply with the prescribed treatment protocol and
- •evaluations for the duration of the trial.
- •Extension phase:
- •1. Written informed consent.
- 另有 3 项未显示
排除标准
- •Core phase:
- •1. Any of the following cardiovascular diseases:
- •a. uncontrolled, severe hypertension (>=160/100 mmHg), within 6 months of
- •b. myocardial infarction within 6 months of Screening
- •c. unstable cardiac angina within 6 months of Screening
- •2. Interstitial lung disease (ILD) associated with known primary diseases
- •(e.g., sarcoidosis, amyloidosis and coronavirus disease 2019 [COVID-19]),
- •connective tissue disorders (e.g., rheumatoid arthritis, systemic lupus
- •erythematosus, Sjogren*s, dermatomyositis, scleroderma), exposures (e.g.,
- •radiation, silica, asbestos and coal dust) or drugs (e.g., amiodarone).
- •3. Known active bacterial, viral, fungal, mycobacterial or other infection,
- •including tuberculosis or atypical mycobacterial disease (fungal infections of
- •nail beds are allowed). The subject must be 3 months beyond any acute
- •infection with COVID-19 if there has been a prior infection.
- •4. Clinically significant pulmonary hypertension requiring chronic medical
- •5. Use of any of the following therapies within 4 weeks prior to Screening,
- •during the Screening Period or planned during the trial: prednisone at steady
- •dose >10 mg/day or equivalent or cyclosporine. Prednisone <=10 mg/day (or
- •equivalent dosing of glucocorticoids) is allowed. Change in regimen or dosage
- •of any immunosuppressant during the Screening Period through the end of trial
- •participation will require consultation with and approval by the trial Medical
- •Monitor. See Section 9.4.9 for full details. Avoiding the use of listed
- •prohibited treatments must not be considered detrimental and must be indicated
- •by the treating physician. Subjects must not be withdrawn from any
- •standard-of-care treatment that is considered necessary for the clinical
- •management of the subject in order to fulfill the trial eligibility
- •requirements.
- •6. Use of rifampin within 2 weeks prior to Day 1 or planned during the trial.
- •7. Malignant condition in the past 5 years (except successfully treated
- •basal/squamous cell carcinoma of the skin or cervical cancer in situ).
- •8. Women of childbearing potential (WOCBP) or male subjects not agreeing to use
- •highly effective method(s) of birth control throughout the trial and for 4
- •weeks after last dose of trial drug. Females must refrain from egg/ova
- •donation for 4 weeks after the last dose of trial drug and males must refrain
- •from sperm donation for 3 months after the last dose of trial drug. Women are
- •considered of childbearing potential if they are not postmenopausal and not
- •surgically sterile (documented bilateral salpingectomy, bilateral oophorectomy
- •or hysterectomy). A postmenopausal state is defined as no menses for 12 months
- •without an alternative medical cause. A high follicle-stimulating hormone
- •(FSH) level in the postmenopausal range may be used to confirm a postmenopausal
- •state in women not using hormonal contraception or hormonal replacement
- •therapy. However, in the absence of 12 months of amenorrhea, a single FSH
- •measurement is insufficient. Fertile male subjects must use a condom
- •throughout the trial and for 4 weeks after the last dose of trial drug. A man
- •is considered fertile after puberty unless permanently sterile by bilateral
- •orchidectomy.
- •9. Pregnant or lactating women and women who plan to become pregnant or breast
- •feed during the trial and withi
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