A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS

Receptos Inc,0 个研究点目标入组 0 人开始时间: 2015年9月4日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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
•4.EDSS score between 0 and 5.0 at baseline
•5.Meet one of the following disease activity criteria: At least 1 documented relapse within the last 12 months prior to screening, OR 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 7.Ability to provide written informed consent 8.Patients of reproduction potential must practice an acceptable method of birth control (see protocol) during study participation and for 30 days after their last dose of treatment of study medication or true sexual abstinence (see protocol)
•9.Patients must have documentation of positive Varicella zoster virus (VZV) IgG antibody status or complete VZV vaccination at least 30 days prior to randomization.

•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
•4.Incompatibility with beta IFN use
•5.Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (β-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
•7.Specific cardiac conditions are excluded
•8.Resting heart rate less than 55 bpm at Screening
•9.Diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c >9% , or diabetic patients with significant co-morbid conditions such as retinopathy or nephropathy
•10.History of uveitis
•11.Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease
•12.History or known presence of recurrent or chronic infection (e.g., hepatitis A, B, or C, human immunodeficiency virus (HIV), syphilis, TB); recurring urinary tract infections could be allowed
•13.History of cancer
•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

发起方