EUCTR2015-004059-29-IT进行中（未招募）1 期
An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GENEURO SA
- 入组人数
- 260
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
- •- Diagnosis of relapsing remitting multiple sclerosis according to Mc Donald criteria (2010)
- •- Evidence of recent disease activity: at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;
- •- Body weight > 40 kg and = 100 kg;
- •- EDSS score < 6.0
- •- Patient (male or female with reproductive potential) who agree to use a highly effective method of birth control.
- •-Other criteria as stated in study protocol
- •-Clinical stability for 30 days prior to selection
- •- Results of physical examination and laboratory tests must be available and free of any clinical significant abnormality likely to interfere with the study conduct or evaluation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 260
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients suffering from secondary progressive MS (SPMS) or primary progressive MS (PPMS);
- •- Any disease other than MS that could better explain signs and symptoms;
- •- Complete transverse myelitis or bilateral optic neuritis;
- •- Patients who have been treated with: oral or systemic corticosteroids, adrenocorticotropic hormone (ACTH) within 30 days prior to selection ; interferon beta or glatiramer acetate, intravenous immunoglobulin (IVIG), natalizumab, dimethylfumarate, teriflunomide, laquinimod or fingolimod in the last 3 months prior to selection ; mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, cytotoxic or immunosuppressive therapy (excluding systemic steroid and ACTH), total lymphoid irradiation or bone marrow transplantation at any time ; any cytokine (other than interferon), B cell modulating therapy such as anti-CD 20 antibodies such as ocrelizumab, ofatumumab or rituximab or daclizumab (anti-CD 25 antibody), or anti-cytokine therapy, plasmapheresis or azathioprine in the last 6 months prior to selection ; ongoing treatment with an experimental drug; preceding treatment with another experimental drug if not washed out for = 5 halflives or = 3 months (whichever is longer);
- •- CTCAE Grade 2 or greater lymphopenia following treatment with an immunosuppressor or immunomodulator;
- •- Any major medical or psychiatric disorder
- •- History or presence of serious or acute heart disease
- •- Known inability to undergo an MRI scan
- •- patients with contraindications to the use of gadolinium-containing contrast agents or glucose 5% solution for infusion
- •- positive serology for hepatitis B/C , HIV
- •- abnormal liver function tests (ASAT, ALAT, Total bilirubin >2ULN; AP >3 ULN)
- •- Moderate to Severe Renal impairment
- •- positive pregnancy test
- •- Treatment-naïve patients: patients who have never been treated with a disease modifying treatment
- •- other criteria as stated in the study protocol
研究者
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