NL-OMON37285尚未招募2 期
A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis - CNTO888PUL2001
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 16
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
- •1. Aged 40 to 80, inclusive.
- •a. Subjects who are aged 40 years to < 50 years of age at the time of screening
- •will be required to have surgical lung biopsy evidence of UIP in order to be
- •considered eligible for the trial.
- •2. Physician diagnosis of IPF (according to a modified version of the ATS/ERS
- •criteria; ATS, 2000) within 4 years of screening.
- •Subjects must meet all of the major criteria and 3 of the 4 minor criteria listed
- •Major criteria (must meet all)
- •a. Exclusion of other known causes of interstitial lung disease, such as certain
- •drug toxicities, environmental exposures, and connective tissue diseases.
- •b. Abnormal pulmonary function studies that include evidence of restriction
- •(reduced vital capacity, often with an increased FEV1/FVC ratio) and
- •impaired gas exchange (increased alveolar-arterial oxygen gradient
- •[P(A-a)O2] or evidence of desaturation at rest or exercise or decreased
- •c. Bibasilar reticular abnormalities with minimal ground-glass opacities on
- •HRCT scans.
- •Minor Criteria (must meet 3)
- •a. Age > 50 years.
- •b. Insidious onset of otherwise unexplained dyspnea on exertion.
- •c. Duration of illness * 3 months.
- •d. Bibasilar, inspiratory crackles (dry or *Velcro-type* in quality).
- •3. Have surgical lung biopsy evidence of UIP and/or HRCT scan-based diagnosis of
- •IPF. In the absence of surgical lung biopsy, an HRCT scan obtained within
- •3 months prior to or at screening must be available for review.
- •4. Have evidence of progressive IPF disease activity despite current treatment.
- •Progressive IPF disease activity, for the purposes of this protocol, is defined as
- •having 1 or more of the following within the past 12 months:
- •a. Relative decrease of * 10% in FVC.
- •b. Relative decrease of * 15% in DLCO.
- •c. Evidence of clinically significant worsening on HRCT (eg, development of
- •honeycombing, increase in opacities).
- •d. Significant worsening of dyspnea at rest or with exertion.
- •5. Evidence of recent stability of percent-predicted FVC (defined as not having
- •changed > 15% at the baseline visit relative to the screening visit).
- •6. FVC * 50% of the predicted value at screening.
- •7. Women of childbearing potential must have a negative serum pregnancy test result
- •at screening. Women of childbearing potential and all men must be using adequate
- •birth control measures and must agree to continue to use such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last
- •infusion of study agent.
- •8. Are considered eligible according to the following TB screening criteria:
- •a. Have no history of latent or active TB prior to screening.
- •b. Have no signs or symptoms suggestive of active TB upon medical history
- •and/or physical examination.
- •c. Have had no recent close contact with a person with active TB.
- •d. Within 2 months prior to the first administration of study agent, have
- •negative diagnostic TB test results (defined as a negative QuantiFERON-TB
- •Gold test).
- •e. Have a chest radiograph (both posterior-anterior and lateral views) if
- •clinically indicated or HRCT taken within 3 months prior to screening and
- •read by a qualified radiologist, with no clear evidence of current active TB or
- 另有 3 项未显示
排除标准
- •1. Have evidence of interstitial pneumonia other than IPF.
- •2. Diagnosis of IPF is not confirmed by HRCT or lung biopsy results.
- •3. Partial pressure of oxygen in arterial blood (PaO2) < 55 mmHg (sea level) or
- •50 mmHg (altitude) at rest on room air. If arterial blood gas results are not
- •available, an oxygen saturation via pulse oximetry (SpO2) < 88% with O2
- •supplementation at rest.
- •4. Known clinically significant pulmonary hypertension requiring vasodilator therapy
- •(eg, calcium channel blockers, prostacyclin or prostacyclin analogs, nitric oxide,
- •adenosine) or chronic anticoagulation therapy.
- •5. Have a diagnosis of other significant respiratory disorder (eg, asthma, TB,
- •sarcoidosis, aspergillosis, chronic obstructive pulmonary disease [COPD], or cystic
- •6. Have obstruction on prebronchodilator PFTs (defined as FEV1/FVC < 0.7) at
- •7. Demonstrate an increase in FEV1 * 12% postbronchodilator.
- •8. Have a predicted life expectancy less than 1 year.
- •9. Previous treatment for IPF with an investigational/experimental medication within
- •6 weeks, or within 5 t1/2 of the investigational/experimental medication, whichever
- •is longer, prior to screening or are participating in another investigative study.
- •10. Current treatment with sildenafil, IFN-*, mycophenolate, or endothelin receptor
- •antagonists.
- •11. Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
- •hematologic, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease, or
- •any laboratory abnormality which would pose/suggest a risk to the subject by
- •participation in the study.
- •12. Known to be seropositive for HIV, known active hepatitis A, B, or C infection, or
- •ALT/SGPT and/or AST/SGOT > 2 times the upper limit of normal at screening.
- •13. Within 3 months prior to screening, have had a clinically important, serious
- •infection (eg, hepatitis, pneumonia, or pyelonephritis), have been hospitalized for
- •an infection, or have been treated with IV antibiotics for an infection. Less serious
- •infections (eg, acute upper respiratory tract infection or simple urinary tract
- •infection) need not be considered exclusions at the discretion of the investigator.
- •14. Opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii) within
- •6 months prior to screening.
- •15. Received any live attenuated vaccination (eg, FluMist) within 3 months prior to
- •screening or are expected to receive any live attenuated vaccinations during the trial
- •or up to 3 months after the last administration of study agent. Inactivated,
- •injectable influenza and pneumococcal vaccines are permissible.
- •16. Serious concomitant illness that could interfere with the subject*s participation in
- •17. History of substance abuse (drugs or alcohol) within the 3 years prior to screening, history of noncompliance to medical regimens, or other condition/circumstance that could interfere with the subject*s adherence to protocol requirements (eg,
- •psychiatric disease, lack of motivation, travel).
- •18. Major surgery within 1 month prior to screening or planned surgery during the
- •19. Currently listed for lung transplantation.
- •20. Have any known malignancy or have a history of malignancy within the previous
- •5 years (with the exception of a nonmelanoma skin cancer that has been treated
- •with no evidence
研究者
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