EUCTR2017-004302-18-SK进行中（未招募）1 期
A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galapagos NV
- 入组人数
- 60
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
- •Subjects who meet all of the following criteria are eligible for the study:
- •- Signed informed consent form (ICF) obtained prior to any study-related
- •procedures and/or assessments performed.
- •- Males or females of non-child-bearing potential, aged =40 years on the
- •day of signing the ICF.
- •- A diagnosis of IPF within 5 years prior to the screening visit as per applicable American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guideline. Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone, or nintedanib at a stable dose for at least 8 weeks before screening, and during screening; or neither pirfenidone nor nintedanib (for any reason). A stable dose is defined as the highest tolerated dose. Prednisone at steady dose =10 mg/day or equivalent glucocorticoid dose is allowed (stabilized 4 weeks prior to screening and continued without variation of dose or regimen). Supportive care like supplemental oxygen or pulmonary rehabilitation is allowed.
- •- Chest HRCT historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT only (if no lung biopsy [LB] available), or based on both HRCT and LB (with application of the different criteria in either situation). If an evaluable HRCT <12 months is not available, a HRCT can be performed at screening to determine eligibility, according to the same requirements as the
- •historical HRCT.
- •- Meeting all of the following criteria at screening and during the screening period:
- •* FVC =50% predicted of normal
- •* Disease progression, defined as a decline of FVC (% predicted or mL) at the investigator's discretion, during the 9 months prior to the screening period and confirmed at the screening visit * Diffusing capacity for the lungs for carbon monoxide (DLCO) =30% predicted of normal (corrected for hemoglobin)
- •* Ratio of forced expiratory volume in one second (FEV1) to FVC =0.70
- •- In a stable condition and suitable for study participation based on the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation. Stable condition is based on the clinical judgment of the investigator, co-morbidities should be treated according to the local applicable guidelines. Concomitant medication for chronic comorbidities should be stabilized from 4 weeks before screening and during the screening period (stable defined as no clinically relevant change according to the investigator's judgement).
- •- Able to walk at least 150 meters during the 6MWT at screening; without having a contraindication to perform the 6MWT, or without a condition putting the subject at risk of falling during the test (at investigator's discretion). The use of a cane is allowed, the use of a stroller is not allowed at all under any circumstances.
- •For a complete overview of the inclusion criteria refer to the protocol.
- •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 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •Subjects meeting one or more of the following criteria cannot be
- •selected for this study:
- •- Known hypersensitivity to any of the IMP ingredients or a history of a significant allergic reaction to any drug as determined by the investigator (e.g. anaphylaxis requiring hospitalization).
- •- Current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, congenital, acquired, medication induced, organ transplantation).
- •- Positive blood testing for hepatitis B surface antigen (HBs Ag) or hepatitis virus antibody (if positive, confirmed by hepatitis C virus (HCV) RNA positivity). Note: Subjects with a resolved hepatitis A at least 3 months prior to first dosing of the IMP can be included.
- •- History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, and prostate cancer medically managed through active surveillance or watchful waiting, and squamous cell carcinoma of the skin if fully resected).
- •- Acute IPF exacerbation within 3 months prior to screening and during the screening period.
- •- Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
- •- Interstitial lung disease associated with known primary diseases (e.g.
- •sarcoidosis, amyloidosis), exposures (e.g. radiation, silica, asbestos, coal dust), and drugs (e.g. amiodarone).
- •- History of lung volume reduction surgery or lung transplant.
- •- Unstable cardiovascular, pulmonary (other than IPF) or other disease within 6 months prior to screening or during the screening period (e.g. coronary heart disease, heart failure, stroke).
- •- Subject participating in a drug, device or biologic investigational research study, concurrently with the current study, within 12 weeks or 5-half-lives of the agent whichever is longer, prior to screening, or prior participation in an investigational drug antibody/biologic study within 6 months prior to screening.
- •For a complete overview of the exclusion criteria refer to the protocol.
研究者
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