NCT04909502暂停2 期
A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101
Emerald Health Pharmaceuticals4 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2021年10月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Incidence and severity of Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with Relapsing Forms of Multiple Sclerosis (RMS).
详细描述
An interventional, open label, randomized design will be used to test safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in 50 patients ≥ 18 and ≤ 55 years of age with documented RMS. There will be a screening period of up to 28 days, 168 days treatment period, and 28 days follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label design
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 and female adults aged 18 to 55 years at the time of consent;
- •Confirmed diagnosis of MS according to the revised 2017 McDonald criteria;
- •Relapsing forms of MS (RMS) including Relapsing-Remitting MS (RRMS) and active Secondary Progressive MS (SPMS);
- •Patients must have experienced at least 1 of the following within 12 months prior to Visit 1: an acute clinical relapse, gadolinium-enhancing T1 lesions on brain or spinal cord magnetic resonance imaging (MRI), or new T2 lesion(s) on brain or spinal cord MRI;
- •Neurologically stable with no evidence of clinical relapse of MS or corticosteroid treatment within 28 days prior to the first investigational product administration;
- •Naïve to prior MS treatment or discontinuing current MS treatment due to (1) intolerability, (2) laboratory abnormalities, (3) current treatment perceived by the patient to be ineffective, (4) patient preference, or (5) based on investigator judgement to switch MS therapy;
- •An EDSS score of 0 to 6.0 (inclusive) at screening and enrolment visit;
- •Willing and able to provide informed consent and capable of understanding and complying with the protocol.
排除标准
- •Primary progressive MS (PPMS) or non-active secondary progressive MS (SPMS);
- •Relapse during the 28 days prior to first investigational product administration;
- •Total lymphoid irradiation, T-cell or T-cell receptor vaccination, total body irradiation, or total lymphoid irradiation at any time;
- •Treatment with alemtuzumab, mitoxantrone, cyclophosphamide or cladribine at any time;
- •MS treatment that may impact the efficacy or safety assessment defined as follows:
- •52 weeks or less prior to first investigational product administration: Immunosuppressant agents (e.g., cyclosporine, methotrexate, mycophenolate)
- •36 weeks or less prior to first investigational product administration: CD20 depletion therapies such as rituximab, ocrelizumab, ofatumumab or others. Condition for inclusion of patients who had CD20 depletion therapies more than 36 weeks prior to the first investigational product administration: may only be included if there is no clinically relevant B cell depletion and possible safety risk to patients based on the Investigator's opinion.
- •12 weeks or less prior to first investigational product administration: natalizumab
- •8 weeks or less prior to first investigational product administration: dimethyl-fumarate fingolimod
- •4 weeks or less prior to first investigational product administration: corticosteroids intravenous immunoglobulin (IVIG) ozanimod, siponimod, or ponesimod glatiramer acetate interferons
- •2 weeks or less prior to first investigational product administration: teriflunomide. Subject must exhibit no active agent in serum levels; cholestyramine or activated charcoal washout may be used to achieve this;
- •Any one of the following values for laboratory test at screening:
- •Haemoglobin < 9 g/dL;
- •Neutrophils < 1.0 x 10^9/L;
- •Platelets < 75 x 10^9/L;
- •Serum transaminases > 2.0 x upper limit of normal;
- •Total bilirubin ≥ 1.5 x upper limit of normal;
- •Thyroid-stimulating hormone level >10% above of the upper limit of normal;
- •Estimated glomerular filtration rate ≤60 mL/min/1.73m2 (using the Cockcroft-Gault equation);
- •Lymphocytes < 1 × 10^9/L;
研究组 & 干预措施
EHP-101 Twice a day (BID)
Experimental
干预措施: EHP-101 50 mg BID (Drug)
EHP-101 Once a day (OD)
Experimental
干预措施: EHP-101 25 mg OD (Drug)
EHP-101 Once a day (OD)
Experimental
干预措施: EHP-101 50 mg OD (Drug)
EHP-101 Twice a day (BID)
Experimental
干预措施: EHP-101 25 mg BID (Drug)
结局指标
主要结局
Incidence and severity of Treatment Emergent Adverse Events
时间窗: 168 days (24 weeks)
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments
次要结局
- Disease progression measured by Expanded Disability Status Scale (EDSS)(168 days (24 weeks))
- Brain lesion activity measured by MRI(168 days (24 weeks))
- Disease progression measured by MS Functional Composite (MSFC)(168 days (24 weeks))
- Disease progression measured by Symbol Digit Modalities Test (SDMT)(168 days (24 weeks))
- Time to first relapse(168 days (24 weeks))
- Percent of patients who experience a relapse(168 days (24 weeks))
- Disability status measured by MS Functional Composite (MSFC)(168 days (24 weeks))
- Disability status measured by Expanded Disability Status Scale (EDSS)(168 days (24 weeks))
- Proportion of patients who remain qualified as relapse-free(168 days (24 weeks))
- Disability status measured by Symbol Digit Modalities Test (SDMT)(168 days (24 weeks))
- Preliminary Annualized Relapse Rate (ARR)(168 days (24 weeks))
- Change in blood levels of neurofilament light chain (NfL)(Baseline, 28 Days, 56 Days, 84 Days, 112 Days, 140 Days, 168 Days)
研究者
研究点 (4)
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