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)
概览
- 阶段
- 3 期
- 干预措施
- IMU-838 tablets
- 疾病 / 适应症
- Multiple Sclerosis
- 发起方
- Immunic AG
- 入组人数
- 1121
- 试验地点
- 91
- 主要终点
- To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
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
研究者
入排标准
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.
研究组 & 干预措施
IMU-838
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
Placebo
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
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)