NCT04625153终止2 期
RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection in Patients With Relapsing Remitting Multiple Sclerosis：a Phase II Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- 48-week annual recurrence rate (ARR)
研究概览
简要总结
To observe the safety and effectivity of a Recombinant Human B Lymphocyte Stimulator Receptor : Immunoglobulin G( IgG ) Fc Fusion Protein for injection (RC18) in patients with relapsing remitting multiple sclerosis, analyze the dose-response relationship and provide a dose basis for follow-up clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with relapsing remitting multiple sclerosis meet the diagnostic criteria of McDonald
- •18-55 years old, male or female
- •At least 1 recurrence was recorded within 1 year prior to randomization, or at least 2 recurrences within 2 years (the first clinical episode of MS was recorded as a recurrence), or active gadolinium enhanced lesions in the brain within 1 year prior to screening.
- •Neurological symptoms were stable for ≥30 days before screening and before baseline
- •EDSS score ≤ 5.5
- •Informed consent signed voluntarily
排除标准
- •Patients who were unable to undergo magnetic resonance imaging or who were allergic to gadolinium contrast agents during the trial
- •In addition to multiple sclerosis, patients with chronic active immune system diseases or who are stable but require immunotherapy (glucocorticoids and/or immunosuppressants) (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis), Or patients with known immunodeficiency syndromes (AIDS, genetic immunodeficiency, and drug-induced immunodeficiency); Patients who received glucocorticoid maintenance therapy before randomization could participate in the trial after discontinuing the drug.
- •Patients who were AQP4 antibody positive and/or MOG antibody positive within 1 year prior to randomization
- •Patients who have received the following treatment:
- •Interferon, pegylated interferon, glatirex acetate, and dimethyl fumarate were used within 4 weeks prior to randomization.
- •Use of Fingomod, intravenous immunoglobulin, or plasmapheresis within 12 weeks prior to randomization.
- •Alemtuzumab, Daclizumab, Ocrelizumab were administered within 24 weeks prior to randomization.
- •Azathioprine (AZA, half-life t1/2=6hrs), Mycophenolate Mofetil (t1/2=16hrs), Leflunomide (LEF, LEflunomide) were used before randomization. t1/2=15 days), Tacrolimus (t1/2=43 hrs), Teriflunomide (t1/2=18 days), Cyclosporin (CsA) Patients with immunosuppressants such as t1/2=27 hrs), Methotrexate (MTX, t1/2=14hrs), Cyclophosphamide (CTX, t1/2=6hrs), in addition to leflunomide and teriflunomide, The discontinuation interval was more than 5 times the half-life. Leflunomide and Teriflunomide need to be eluted with coletenide, which can be discontinued and the following measures taken: Coletenide 8 g 3 times daily for 11 days, if the 8 g dose is not tolerated, can be changed to 4 g orally for the same time and frequency as before.
- •Use of clatribine or mitoxantrone within 1 year prior to randomization.
- •Received lymphoid irradiation and bone marrow transplantation before randomization.
- •Patients were participated in any clinical trial 28 days before randomization or within 5 times half-life of study drug participating in clinical trial (whichever is longer).
- •Patients with any persistent or chronic active infection or serious infection history in the screening period, such as shingles; active tuberculosis (patients with latent tuberculosis can participate in the test if they are given isoniazid and / or rifampin at the same time); HIV infection; syphilis antibody positive; HCV antibody positive; HBsAg positive; HBsAg negative but HBcAb positive, the HBV-DNA quantitative test is needed. If the HBV-DNA is positive, the patient should be excluded. If the HBV-DNA is negative, the patient can not be excluded.
- •The results of abnormal laboratory tests to be excluded include but are not limited to: Leukocyte count < 3 × 10~9 / L; neutrophil < 1.5 × 10~9 / L; hemoglobin < 85g / L; platelet count < 80 × 10~9 / L; serum creatinine > 1.5 × ULN, accompanied by creatinine clearance < 50ml / min (measured value, or calculated by Cockcroft Gault formula); total bilirubin > 1.5 × ULN; ALT > 3 × ULN; AST > 3 × ULN; alkaline phosphatase > 2 × ULN; IgG < lower limit of normal value; IgM < lower limit of normal value;
- •Cancer patients
- •Pregnant women, lactating women and patients with family planning during the trial
- •Patients with other mental disorders
- •Patients who experienced any of the following events within 12 weeks before randomization: myocardial infarction, unstable ischemic heart disease, stroke, or NYHA class IV heart failure
- •The researchers believe that the patients are compliant insufficiently or not suitable to participate in this study.
研究组 & 干预措施
RC18 160mg
Experimental
RC18 160mg is injected subcutaneously once a week for 48 times.
干预措施: RC18 160mg (Biological)
RC18 240mg
Experimental
RC18 240mg is injected subcutaneously once a week for 48 times.
干预措施: RC18 240mg (Biological)
结局指标
主要结局
48-week annual recurrence rate (ARR)
时间窗: 0- 48 weeks
48-week annual recurrence rate (ARR). ARR is calculated as the total number of relapses for all subjects divided by the total number of years of subjects receiving this treatment
次要结局
- Changes in EDSS scores from baseline at weeks 12, 24, 36 and 48(At 12, 24, 36 and 48 weeks)
- Proportion of patients without recurrence at weeks 0 to 48(0- 48 weeks)
- 12 weeks confirmed disability progression(0-12weeks)
- Number of new low-signaling T1 lesions in the brain(At 12, 24, 36 and 48 weeks)
- Number of new/new large T2 lesions in the brain(At 12, 24, 36 and 48 weeks)
- 12 weeks confirmed disability improvement(0-12weeks)
- 24 weeks confirmed disability progression(0-24weeks)
研究者
研究点 (1)
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