EUCTR2010-023047-15-DE进行中（未招募）1 期
A Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease
Celgene Corporation0 个研究点目标入组 88 人开始时间: 2011年12月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
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.Male or female subjects between 18 and 80 (inclusive) at the time of signing the ICD
- •2.Body weight =80pounds (36.3kg) at Screening and Baseline
- •3.Understand and voluntarily sign ICDs prior to the initiation of any study-related assessments/procedures
- •4.Able to adhere to the study visit schedule and other protocol requirements
- •5.Diagnosis of SSc as defined by ACR criteria. Subjects will be further classified into lSSc and dSSc based on the criteria presented in Appendix A.
- •6.Onset of the first non-Raynaud's manifestation of SSc within 7 years of Screening
- •7. Subjects are required to meet at least one of the following 2 pulmonary-related criteria to be eligible for the study:
- •-FVC readings = 45% and < 70% at Screening and Baseline (Visit 2) [with or without a documented pre-specified FVC decline or fibrosis
- •-FVC readings = 70% and = 80% at Screening and Baseline (Visit 2) with a documented history of either or both of:
- •a) A = 5% decrease (expressed as percent predicted or in liters) in FVC in the 24-month period prior to Baseline (Visit 2) based on 3 or more
- •assessments. Two assessments may be done during the Screening phase provided the assessments are completed at least 2 weeks apart.
- •b) An HRCT fibrosis score > 20%
- •8.Repeat FVC at Baseline within 5% of the FVC measured at Screening
- •9.DLco = 35% and 10.Abnormalities on HRCT consistent with parenchymal changes encountered in SSc: honeycombing or reticular changes with or without ground glass. These changes are usually symmetrical and are often in subpleural and basal locations. Some involvement of both lungs is required.
- •11.Must meet the following laboratory criteria:
- •-Hemoglobin =10.0 g/dL
- •-White blood cell (WBC) count = 3000 /microL (= 3.0 x 109/L) and -Absolute neutrophil count (ANC) = 2 x 109/L
- •-Platelet count = 150,000 /microL (= 150 X 109/L)
- •-MDRD eGFR = 60 mL/min
- •-Total bilirubin -Albumin = 3.0 g/dL
- •-Aspartate transaminase and alanine transaminase = 1.5 X ILN
- •-Negative hepatitis B surface antigen is required. Subjects may have a positive anti-hepatitis B core antibody if the anti-hepatitis B surface antibody is positive as well
- •12.Females of childbearing potential must undergo pregnancy testing based on the frequency outlined in Appendix H and pregnancy results must be negative.
- •13.Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods as specified in Appendix H.
- •-Abstinence is only acceptable in cases where this is the preferred and usual lifestyle of the subject. Periodic abstinence (calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
- •14.Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with FCBP as specified in Appendix H.
- •15.Males must agree not to donate semen or sperm for the duration specified in Appendix H.
- •16.All subjects must:
- •-Understand that the IP could have a potential teratogenic risk.
- •-Agree to abstain from donating blood while taking IP and following discontinuation of investigational product
- •-Agree not to share IP with another person.
- •-Other than the sub
排除标准
- •1.Oxygen saturation<92%(room air [sea level] at rest) at Screening or Baseline
- •2.Known diagnosis of obstructive lung disease as defined by FEV1/FVC ratio <0.7
- •3.Diagnosis of pulmonary arterial hypertension (PAH) requiring treatment
- •4.Known diagnosis of other significant respiratory disorders
- •5.Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study
- •6. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •7.Any condition that confounds the ability to interpret data from the study
- •8.Pregnant or lactating females
- •9.Current clinical diagnosis of another inflammatory connective tissue disease (eg, systemic lupus erythematosus, rheumatoid arthritis, primary Sjogren's syndrome, etc.) Subjects having Sjogren's syndrome secondary to SSc are eligible.
- •10.History of a thromboembolic event
- •11.Family history of genetic disease associated with deep vein thrombosis or
- •thromboembolism
- •12. History of clinically significant endocrinologic, pulmonary (other than SSc-related), GI (other than SSc-related), neurologic, psychiatric, hepatic, renal, hematologic, cardiovascular, immunologic or other major uncontrolled disease
- •13.History or current diagnosis of peripheral neuropathy
- •14.History of alcohol or drug abuse
- •15.History of any of the following cardiac conditions within 6 months of Screening: acute myocardial infarction, acute coronary syndrome, new onset atrial fibrillation, new onset atrial flutter, second- or third-degree atrioventricular block, ventricular fibrillation, ventricular tachycardia, heart failure, cardiac surgery, interventional cardiac catheterization (with or without a stent placement), interventional electrophysiology procedure, presence of implanted permanent pacemaker or presence of implanted defibrillator
- •16.History of additional risk factors for torsade de pointes
- •17.Corrected QTcF>440msec on 2 of 3 Screening or Baseline ECGs (predose)
- •18. Presence of any of the following on 2 of the 3 Screening or Baseline ECGs (pre-dose) at rest: heart rate<50beats/min or >110beats/min, PR interval>220ms, QRS duration>110ms
- •19.Clinically significant abnormality on any 2 of 3 Screening or Baseline ECGs
- •20.History of tuberculosis
- •21.History of HIV infection
- •22.History of congenital and acquired immunodeficiencies
- •23.Hepatitis B surface antigen positive. A positive anti-HBc without a positive anti-HBs at Screening
- •24.Antibodies to hepatitis C at Screening
- •25.History of malignancy
- •Prior treatments
- •26.Use of concomitant medication(s) which could increase the risk for developing deep vein thrombosis
- •27.Use of melphalan within 52 weeks of Screening
- •28.The addition of concomitant medications associated with QT prolongation during the course of the study
- •29.Use of any anti-coagulant or anti-thrombotic medications (other than low dose-aspirin [(Investigator feels it is medically appropriate.
- •30.Use of any cytotoxic/immunosuppressive agent (other than prednisone = 10 mg/day [mean dose] or equivalent), including but not limited to azathioprine, cyclophosphamide, methotrexate
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