CTIS2022-502618-95-00招募中1 期
A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis - GN42272
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 715
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •1. Expanded Disability Status Scale score (EDSS) of 0.0-5.5 at screening, 2. A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria, 3. Neurologically stable for at least 30 days prior to randomization and baseline assessments, 4. Ability to complete the 9-HPT for each hand in < 240 seconds, 5. Ability to perform the timed 25-Foot Walk Test in <150 seconds, 6. OLE Inclusion Criteria: Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib.
排除标准
- •1. A diagnosis of PPMS or non-active secondary progressive Multiple sclerosis (SPMS), 2. Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0, 3. Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to and during screening or treatment with oral anti-microbials within 2 weeks prior to and during screening. Onychomycosis is not exclusionary unless it is being treated with systemic therapy, 4. History of cancer including hematologic malignancy and solid tumors within 10 years of screening., 5. Known presence of other neurological disorders that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease, 6. Any concomitant disease that may require chronic treatment with systemic corticosteroids, or immunosuppressants during the course of the study
研究者
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