EUCTR2013-002916-28-LV进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female out-patients (except where an in-patient stay is required according to standard local practice for lumbar puncture) aged 18 to 65 years of age inclusive at the time of informed consent
- •2. Willing and able to provide written informed consent and to comply with the requirements of the protocol assessments/procedures
- •3. Relapsing MS
- •4. Clinical evidence of recent MS activity defined as either
- •- at least one documented relapse in the previous 12 months prior to Visit 2, or
- •- at least two documented relapses in the previous 24 months prior to Visit 2.
- •5. Radiological activity on Gd-enhanced MRI defined as both
- •- at least one CEL on MRI at Visit 2, and
- •- an increase of at least one CEL from Visit 2 to Visit 4, i.e., over the 8-week Baseline Control Period.
- •6. EDSS score 0-5.5
- •7. HLA-DRB1*15 positive
- •8. Neurological stability in the 30 days prior to Visit 5 (Study Day 1)
- •9. Prior vaccination against tuberculosis (TB)
- •10. 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
- •11. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Primary progressive MS
- •2. 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
- •3. Previous treatment with ß-interferon, plasma exchange, intravenous gamma globulin within the 8 weeks prior to Study Day 1 (Visit 5); subjects receiving such treatment at Visit 2 (i.e.,
- •at the start of the Baseline Control Period) must discontinue treatment and commence washout as soon as it has been confirmed that they are eligible for the trial based on their
- •Visit 2 MRI scan
- •4. Previous treatment with steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone within the 30 days prior to the Visit 2 MRI scan; subjects
- •receiving such treatment at screening (Visit 1) must have completed treatment 30 days prior to the Visit 2 MRI scan
- •5. Previous treatment with glatiramer acetate
- •6. Previous treatment with: cytotoxic agents (including but not limited to cladribine, mitoxantrone, cyclophosphamide, azathioprine, methotrexate), fingolimod, laquinimod,
- •teriflunomide, total lymphoid irradiation, stem cell or bone marrow transplantation, or monoclonal antibody therapy (including natalizumab, daclizumab, alemtuzumab, ocrelizumab)
- •7. Prior exposure to dimethyl fumurate (BG-12) or dirucotide
- •8. Prior exposure to any disease-related T cell vaccine or peptide-tolerizing agent for the treatment of MS, including ATX-MS-1467
- •9. Use of any investigational drug or experimental procedure for MS (including cytokine or anticytokine therapy) within the 30 days prior to screening (Visit 1)
- •10. Inadequate liver function, defined by aspartate aminotransferase or alanine aminotransferase (ALT) > 3 times the upper limit of normal at screening or at any of the pre-treatment visits (Visits 2-4)
- •11. Lymphocyte count < 500/µL or neutrophil count < 1500/µL at screening or at any of the pre-treatment visits (Visits 2-4)
- •12. Major medical illness such as cardiac, endocrinological, hepatic, immunological (other than MS), metabolic, genito-urinary, pulmonary, gastrointestinal, dermatological, or other major
- •disease that would preclude participation in the trial
- •13. Known history of active or chronic infectious disease or any disease which compromises immune function (e.g., positive for human immunodeficiency virus, human T-lymphotrophic
- •virus-1, untreated Lyme disease, untreated TB or hepatic viral disease [hepatitis B and C])
- •14. Any renal condition that would preclude the administration of gadolinium, e.g., acute or chronic severe renal insufficiency (glomerular filtration rate [GFR] < 30 mL/min/1.73 m2)
- •15. 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
- •16. Clinical evidence of severe uncontrolled depression, active suicidal ideation or suicide attempt
- •17. 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
- •18. Major surgery in the 4 weeks prior to screening (Visit 1)
- •19. Known hypersensitivity to the trial medication or diluents
- •20. Participa
研究者
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