NCT01973491已完成2 期
An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and Its Effect on Immune Tolerance in Subjects With Relapsing Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans
研究概览
简要总结
This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing multiple sclerosis (MS) and to assess the maintenance of any such effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female out-patients aged 18 to 65 years of age inclusive at the time of informed consent
- •Willing and able to provide written informed consent and to comply with the requirements of the protocol assessments/procedures
- •Relapsing MS (relapsing-remitting multiple sclerosis [RRMS], secondary progressive multiple sclerosis [SPMS], as defined by the revised McDonald criteria [2010]) (11)
- •Clinical evidence of recent MS activity and radiological activity on gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) defined as defined in the protocol
- •Expanded disability status scale (EDSS) score 0-5.5
- •Human leukocyte antigen-beta chain (HLA-DRB)1*15 positive
- •Neurological stability in the 30 days prior to Visit 5 (Study Day 1)
- •Prior vaccination against tuberculosis (TB)
- •If female, unless post-menopausal (for at least 2 years) or surgically sterilized, must be willing to use two highly effective methods of contraception throughout the entire duration of the trial and for 90 days following the last dose of ATX-MS-1467
- •If male, must be willing to use two highly effective methods of contraception throughout the entire duration of the trial and for 90 days following the last dose of ATX-MS-1467
排除标准
- •Primary progressive MS
- •Inability to comply with MRI scanning, including contra-indications to MRI such as known allergy to gadolinium contrast dyes, claustrophobia, presence of a pacemaker, cochlear implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, nerve stimulators
- •Previous treatment with beta-interferon, plasma exchange, intravenous gamma globulin within the 8 weeks prior to study Day 1 (Visit 5), steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone within the 30 days prior to the Visit 2 MRI scan, glatiramer acetate, cytotoxic agents
- •Prior exposure to dimethyl fumurate (BG-12) or dirucotide, any disease-related T cell vaccine or peptide-tolerizing agent for the treatment of MS, including ATX-MS-1467
- •Use of any investigational drug or experimental procedure for MS (including cytokine or anticytokine therapy) within the 30 days prior to screening (Visit 1)
- •Inadequate liver function as defined in the protocol.
- •Lymphocyte count less than (<)500 per micro liter (/mcL) or neutrophil count < 1500 mcL at screening or at any of the pre-treatment visits (Visits 2-4)
- •Major medical illness as defined in the protocol
- •Known history of active or chronic infectious disease or any disease which compromises immune function
- •Any renal condition that would preclude the administration of gadolinium
- •History of malignancy, including both solid tumor and hematological malignancies, but excluding basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved, in situ cervical cancer or prostatic cancer with normal prostatic specific antigen
- •Clinical evidence of severe uncontrolled depression, active suicidal ideation or suicide attempt
- •Any other significant medical or psychiatric conditions that, in the opinion of the Investigator, would preclude participation in the trial or impair the ability to give informed consent
- •Major surgery in the 4 weeks prior to screening (Visit 1)
- •Known hypersensitivity to the trial medication or diluents
- •Participation in another clinical trial within the 30 days prior to screening (Visit 1)
- •Pregnancy, lactation or a positive pregnancy test during screening (urine dipstick) or at Visit 4 (serum beta-human chorionic gonadotrophin [beta-hCG]), or intention to become pregnant or to breast-feed during the course of the trial
- •Legal incapacity or limited legal capacity
研究组 & 干预措施
ATX-MS-1467
Experimental
干预措施: ATX-MS-1467 (Drug)
结局指标
主要结局
Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans
时间窗: Baseline (Weeks -8, -4 and 0), Treatment Period (Weeks 12, 16 and 20)
T1 CELs were measured using Magnetic Resonance Imaging (MRI) scans. Baseline value was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0) and On-treatment value was calculated as the average number of T1 CELs during the 3 visits in the treatment period (Weeks 12, 16 and 20). The change from baseline in average number of T1 CELs was reported.
次要结局
- Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)(Weeks 12, 16, 20, 24, 28 and 36)
- Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36(Baseline (Weeks -8, -4 and 0), Weeks 12, 16, 20, 24, 28 and 36)
- Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36(Baseline (Weeks -8, -4, 0), Week 12, 16, 20, 24, 28 and 36)
- Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions(Weeks 12, 16, 20, 24, 28 and 36)
- Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36(Week 0, 12, 16, 20, 24, 28 and 36)
- Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36(Weeks 0, 12, 16, 20, 24, 28 and 36)
- Mean Annualized Relapse Rate(Week 20)
- Time to First Relapse(Baseline up to Week 36)
- Change From Baseline in Total Expanded Disability Status Scale (EDSS) Score at Week 20(Baseline (Week 0) and Week 20)
- Change From Baseline in Total Multiple Sclerosis Functional Composite (MSFC) Score at Week 20(Baseline (Week 0) and Week 20)
- Number of Subjects Experiencing Injection Site Reactions (ISRs)(Baseline up to Week 22)
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation(Baseline up to Week 25)
研究者
研究点 (1)
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