EUCTR2013-003752-21-PL进行中（未招募）1 期
A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 83
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
- •Patients must meet the following criteria for study entry:
- •1. Patients must be diagnosed as having either:
- •a. NMO as defined by 2006 criteria*, or
- •b. NMOSD as defined by either of the following Wingerchuk 2007 criteria with anti aquaporin 4 antibody (AQP4Ab) seropositive status at screening.
- •i) Idiopathic single or recurrent events of longitudinally extensive myelitis (=3 vertebral segment spinal cord magnetic resonance imaging [MRI] lesion)
- •ii) Optic neuritis: recurrent or simultaneous bilateral
- •For patients aged 12 to 17 years, a minimum of 4 patients should be positive for anti-AQP4Ab status at screening‡. ‡Screening result is based on either the blood sample data collected at screening visit, or the blood sample data collected before the screening visit and measured by Sponsor's designee for analysis.
- •2. Clinical evidence of at least 2 documented relapses (including first attack) in the last 2 years prior to screening, at least one of which has occurred in the 12 months prior to screening.
- •3. Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening.
- •4. Age 12 to 74 years, inclusive at the time of informed consent.
- •5. One of the following baseline treatments for relapse prevention must be at stable dose as a monotherapy for 8 weeks prior to baseline**:
- •a. Azathioprine.
- •b. Mycophenolate mofetil.
- •c. Oral corticosteroids.
- •** For patients aged 12 to 17 years, either of the following baseline treatments for relapse prevention can be allowed:
- •d. Azathioprine + oral corticosteroids.
- •e. Mycophenolate mofetil + oral corticosteroids.
- •6. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol.
- •*According to Wingerchuk et al. 2006, a diagnosis of NMO requires all of the following three criteria:
- •I. Optic neuritis
- •II. Acute myelitis
- •III. At least two of three supportive criteria:
- •Contiguous spinal cord lesion identified on an MRI scan extending over 3 vertebral segments
- •Brain MRI not meeting diagnostic criteria for multiple sclerosis
- •NMO-immunoglobulin G seropositive status
- •For adolescents who may be enrolled after the end of the double-blind period, the inclusion criterion 2 is as follows (other criteria are same).
- •Inclusion Criterion 2
- •Clinical evidence of at least 2 documented relapses (including first
- •attack) prior to screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Exclusion criteria related to previous or concomitant therapy:
- •1. Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g. tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time.
- •2. Any previous treatment with anti-cluster of differentiation (CD) 20, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline.
- •3. Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline.
- •4. Treatment with any investigational agent within 3 months prior to baseline.
- •Exclusions for general safety:
- •5. Pregnancy or lactation.
- •6. For patients of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [patient or partner], in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug.
- •7. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline.
- •8. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML).
- •9. Evidence of serious uncontrolled concomitant diseases that may preclude patient participation, such as:
- •other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
- •10. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
- •11. Evidence of chronic active hepatitis B or C.
- •12. History of drug or alcohol abuse within 1 year prior to baseline.
- •13. History of diverticulitis that, in the Investigator’s opinion, may lead to increased risk of complications such as lower gastrointestinal perforation.
- •14. Evidence of active tuberculosis (TB; excluding patients receiving chemoprophylaxis for latent TB infection).
- •15. Evidence of active interstitial lung disease.
- •16. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline.
- •17. History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured).
- •18. History of severe allergic reaction to a biologic agent (e.g. shock, anaphylactic reactions).
- •19. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening.
- •Laboratory exclusion criteria (at screening):
- •20. Following laboratory abnormalities at screening*.
- •a. White blood cells <3.0 x103 /µL
- •b. Absolute neutrophil count <2.0 x 103/µL
- •c. Absolute lymphocyte count <0.5 x 103 /µL
- •d. Platelet count <10 x 104/µL
- •e. Aspartate aminotransferase or alanine aminotransferase >1.5 times the upper limit of normal.
- •* If retest is conducted, the last value of retest before randomization must meet study criteria.
- •For adolescents who may be enrolled after the end of the double-blind period, the annotation * in the exclusion criterion 20 is as follows (other criteria are same).
- •The annotation * in the exclusion criterion 20
- •* If retest
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