EUCTR2010-023047-15-ES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 Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease
Celgene Corporation0 个研究点目标入组 88 人开始时间: 2012年1月19日最近更新:
适应症
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 dc-SSc as defined by ACR criteria
- •6.Onset of the first non-Raynaud?s manifestation of SSc within 5 years of Screening
- •7.FVC>=45% and <=80% predicted at Screening and Baseline. Source documentation confirming a >=5% decrease in FVC based on 3 or more assessments within 18months of Baseline (Visit 2) is required. Two assessments may be done during the Screening Phase provided the assessments are completed at least 2 weeks apart.
- •8.Repeat FVC at Baseline (Visit 2) within 5% of the FVC measured at Screening
- •9.DLco >=40% and <=80% of predicted value at Screening
- •10.Abnormalities on HRCT consistent with sclerodermatous involvement of the lung
- •11.Meet the following laboratory criteria:
- •Hemoglobin >=10.0 g/dL
- •White blood cell (WBC) count >=3000/µL(3.0x10^9/L) and <=14,000/µL
- •(14x109/µL)
- •Absolute neutrophil count (ANC)>=2x10^9/L
- •Platelet count>=150,000/µL(>=150x10^9/L)
- •Serum creatinine<=1.5 mg/dL(<=132.6?mol/L)
- •Total bilirubin<=2.0 mg/dL
- •Albumin>=3.0g/dL
- •AST and ALT<=1.5X upper limit of normal
- •12.Females of childbearing potential (FCBP) must undergo pregnancy testing based and results must be negative
- •13.Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must use adequate contraceptive methods
- •14.Males (including those who have had a vasectomy) must use barrier contraception when engaging in sexual activity with FCBP
- •15.Males must agree not to donate semen or sperm
- •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 IP
- •Agree not to share IP with another person
- •Other than the subject, FCBP and males able to father a child should not handle the IP or touch the capsules, unless gloves are worn.
- •Be counseled about pregnancy precautions and risks of fetal exposure
- •17.Use of concomitant medications for the treatment of SSc-related symptoms is permitted (Proton pump inhibitors or other gastroesophageal reflux disease therapies, Angiotensin receptor blocker, Angiotensin-converting enzyme inhibitor, Selective serum reuptake inhibitors, Calcium channel blockers, Non-sedating oral or intranasal antihistamine agents, PDE5 inhibitors, <=10mg/day of oral prednisone, Oral statin agents for hyperlipidemia, Analgesic or opioid pain medications, Subjects are required to follow a low-dose aspirin regimen (<=100mg/day) unless contraindicated
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
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 <0.65
- •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
- •10.History of a thromboembolic event or hypercoagulable state
- •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 at Screening or Baseline
- •18. Presence of any of the following on 2 of the 3 Screening or Baseline ECGs (pre-dose) at rest: heart rate<45beats/min or >110beats/min, PR interval>220ms, QRS duration>110ms
- •19.Clinically significant abnormality on any Screening or Baseline ECG
- •20.History of tuberculosis
- •21.History of HIV infection
- •22.History of congenital and acquired immunodeficiencies
- •23.Hepatitis B surface antigen positive or hepatitis B core antibody positive at Screening
- •24.Antibodies to hepatitis C at Screening
- •25.History of malignancy
- •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.Use of concomitant medications which prolong the QT/QTc interval
- •29.Use of any anti-coagulant or anti-thrombotic medications
- •30.Use of any cytotoxic/immunosuppressive agent
- •31.Use of prostaglandin analogues
- •32.Use of any biologic agent within 84 days or 5 half-lives of Screening
- •33.Use of endothelin-1 inhibitors
- •34.Use of medications with putative scleroderma disease-modifying properties within 28 days of Screening
- •35.Smoking within 168 days of Screening
- •36.Ingestion of grapefruit, grapefruit juice or grapefruit-containing products within 14 days of randomization
- •37.Use of any investigational drug within 28 days of Screening or 5 PD/PK
- •half-lives
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