EUCTR2012-002714-40-GR进行中（未招募）1 期
A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,280
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
- •Per Protocol dated 14 September 2012.
- •1.MS, as diagnosed by the revised 2010 McDonald criteria
- •2.Exhibiting a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
- •3.Ages 18-55 years, inclusive
- •4.EDSS score between 0 and 5.0 at baseline
- •5.Meet one of the following disease activity criteria:
- •a.At least 1 documented relapse within the last 12 months prior to screening
- •b.At least 1 documented relapse occurred within the last 24 months prior to screening and documented evidence of at least 1 GdE lesion on brain MRI within the last 12 months prior to randomization
- •6.No history of relapse with onset from 30 days prior to screening until randomization; during this period, patients must have been clinically stable, without systemic corticosteroid treatment or adrenocorticotrophic hormone (ACTH)
- •7.Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- •8.Patients of reproduction potential (males and females) must practice an acceptable method of birth control (acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long acting injectable contraceptive, vasectomy or double-barrier method [condom or diaphragm with spermicide]) during study participation and for 30 days after their last dose of treatment of study medication or abstinence
- •9.Documentation of positive Varicella Zoster virus (VZV) IgG antibody status
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range 1280
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Per Protocol dated 14 September 2012.
- •1.Primary progressive MS at screening
- •2.Disease duration of more than 15 years in patients with an EDSS = 2.0
- •3.Contraindications to MRI or Gadolinium contrast, including known allergy to Gadolinium contrast dyes, renal insufficiency, claustrophobia, weight = 300 lb (= 136 kg), pacemaker, cochlear implants, intracranial vascular clips
- •4.Incompatibility with beta IFN use (e.g. intolerable side effects) (Part B only)
- •Exclusions Related to General Health:
- •5.Pregnancy, lactation, or a positive serum beta human chorionic gonadotrophin (hCG) measured during screening
- •6.Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participating in the study in the opinion of treating investigator
- •7.Clinically relevant cardiovascular conditions, including history or presence of ischemic heart disease, myocardial infarction, congestive heart failure, stroke, transient ischemic attack, sick sinus syndrome, recurrent syncope, second degree or higher AV block, prolonged QTcF interval (QTcF > 450 msec males, > 470 msec females), other clinically significant conduction abnormalities or any other significant cardiac condition that could jeopardize a patient’s health during the course of the study in the opinion of treating investigator
- •8.Resting heart rate less than 55 bpm
- •9.History of diabetes mellitus
- •10.History of uveitis
- •11.Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds]) or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or oral antibiotics within 14 days prior to screening
- •12.History or known presence of recurrent or chronic infection (e.g., hepatitis A, B, C, or E, human immunodeficiency virus (HIV), syphilis, TB); recurring urinary tract infections could be allowed
- •13.History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved)
- •14.Suicide attempts in the past or current signs of major depression
- •15.History of alcohol or drug abuse within 1 year prior to randomization
- •16.History of or currently active primary or secondary immunodeficiency
- •Exclusions Related to Medications:
- •17.Prior use of any investigational agent within 6 months prior to enrollment
- •18.Receipt of a live vaccine within 4 weeks prior to screening
- •19.Non-lymphocyte-depleting disease-modifying MS agents (e.g., glatiramer acetate, interferons) must be discontinued from signing of informed consent until randomization
- •20.Previous treatment with lymphocyte-depleting therapies (e.g., alemtuzumab, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation)
- •21.Treatment with other immunosuppressant agents such as azathioprine, cyclosporine, methotrexate, or mycophenolate within 6 months prior to randomization
- •22.Systemic corticosteroid therapy or ACTH use within 30 days prior to screening.
- •23.Prior treatment with lymphocyte trafficking blockers (e.g., natalizumab, fingolimod, other S1PR agonists).
- •24.Treatment with intravenous immune glob
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