NL-OMON53998尚未招募3 期
A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis. - GEMINI-2
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Sanofi B.V.
- 入组人数
- 1
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 64（—）
入选标准
- •*18 to 55 year old male or female with RMS
- •*EDSS score of <= 5.5 points at screening
- •*At least 1 of the following prior to screening:
- •- >=1 documented relapse within the previous year OR
- •- >=2 documented relapses within the previous 2 years, OR
- •- >=1 documented Gd-enhancing brain lesion on an MRI scan within the previous
- •-PPMS diagnosis
- •-Significant infection/at increased infection risk
- •-Significant psychiatric disease or substance abuse
- •-Excess bleeding risk or use of antiplatelets/anticoagulants
- •-Recent use of MS treatments
- •-Significant other concomitant illness/short life expectancy
- •*If female of childbearing potential:
- •--not pregnant or breastfeeding, and agrees to use acceptable contraceptive
- •method during the intervention period (at a minimum until after the last IMP
- •Note. The initial clinical demyelinating episode of MS should be counted as a
- •relapse for the
- •first 2 criteria.
排除标准
- •-Diagnose of PPMS
- •-History of infection or at risk for infection
- •-Presence of psychiatric disturbance or substance abuse
- •-Confirmed laboratory or ECG abnormalities, during the screening visit, deemed
- •by the investigator to be clinically significant.
- •-Conditions that may predispose the participant to excessive bleeding
- •-Conditions that would adversely affect participation in study or make primary
- •efficacy endpoint non-evaluable
- •-Receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or
- •CYP2C8 hepatic enzymes
- •-Receiving anticoagulant/antiplatelet therapies
- •-Sensitivity to study interventions, or drug or other allergy that, per
- •Investigator, contraindicates participation in the study.
- •-Previously exposed to any BTK inhibitor, including SAR442168.
- •-Taken other investigational drugs within 3 months or 5 half-lives, whichever
- •is longer, before SCR.
- •-A relapse in the 30 days prior to randomization
- •-Contraindication for MRI (People with contraindication to gadolinium (Gd) can
- •be enrolled but cannot receive Gd during MRI scan.)
- •-Institutionalized because of regulatory or legal order; prisoners or
- •participants who are legally institutionalized.
- •-Any country-related regulation that would prevent entering the study, if
- •applicable.
- •-Not suitable for participation, whatever the reason, as judged by
- •Investigator, including medical or clinical conditions, or participants
- •potentially at risk of noncompliance to study procedures or not able to follow
- •protocol assessments
- •-Dependent on Sponsor or Investigator
- •-Employees of study site or directly involved in conduct of study, or immediate
- •family members of such individuals.
- •-Any other situation during study course that may raise ethics considerations.
研究者
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