NCT05134441进行中（未招募）3 期
A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Immunic AG
- 入组人数
- 1,121
- 试验地点
- 91
- 主要终点
- To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
研究概览
简要总结
Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1)
详细描述
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient (age ≥18 to ≤55 years).
- •Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
- •Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and
- •Active disease as defined by Lublin 2014 evidenced prior to Screening by:
- •At least 2 relapses in the last 24 months before randomization, or
- •At least 1 relapse in the last 12 months before randomization, or
- •A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization.
- •Willingness and ability to comply with the protocol.
- •Written informed consent given prior to any study-related procedure.
排除标准
- •Patients with non-active secondary progressive MS and primary progressive MS.
- •Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis.
- •Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis
- •Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease)
- •Use of experimental/investigational drug (with the exception ofCOVID-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to Screening
- •Previous or current use of MS treatments lifelong, or within a pre-specified time period.
- •Use of the pre-specified concomitant medications.
- •Clinically significantly abnormal and pre-specified lab values.
- •History of chronic systemic infections within 6 months before the date of informed consent.
- •Diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study.
- •Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis.
- •History or clinical diagnosis of gout.
- •History or presence of any major medical or psychiatric illness
- •Substantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes
研究组 & 干预措施
IMU-838
Experimental
IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH.
Formulation:
Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning.
干预措施: IMU-838 tablets (Drug)
Placebo
Placebo Comparator
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.
干预措施: Placebo matching IMU-838 tablets (Drug)
结局指标
主要结局
To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
时间窗: 72 weeks
Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.
次要结局
- Effect of IMU-838 versus placebo on volume of new T2 lesions(72 weeks)
- Effect of IMU-838 versus placebo on disability progression(72 weeks)
- Effect of IMU-838 versus placebo on cognitive performance(72 weeks)
- Effect of IMU-838 versus placebo on whole brain atrophy(72 weeks)
- Safety of IMU-838 versus placebo(72 weeks)
研究者
研究点 (91)
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相关资讯
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- Interim analysis of the phase 3 ENSURE trials for relapsing multiple sclerosis showed positive outcomes, with completion expected in 2026.
- Vidofludimus Calcium targets Nurr1 activation for neuroprotection and DHODH inhibition for anti-inflammatory and antiviral effects in MS.last yearImmunic's Vidofludimus Calcium Phase 3 Trials for Relapsing MS to Continue Unchanged After Positive Interim Analysis- Immunic's ENSURE program, consisting of two Phase 3 trials evaluating vidofludimus calcium for relapsing multiple sclerosis (RMS), will proceed without modifications.
- An independent data monitoring committee (IDMC) found that pre-determined futility criteria were not met in the ENSURE-1 and ENSURE-2 trials.
- The IDMC also recommended that the sample size in each trial should remain unchanged, with trial completion expected in 2026.
- Vidofludimus calcium is an oral small molecule that reduces MS-related inflammation by blocking DHODH and may activate Nurr1 for neuroprotection.last year