2022-502618-95-00
招募中
3 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
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 35
- 主要终点
- 1.Annualized relapse rate
概览
简要总结
To evaluate the efficacy of fenebrutinib compared with teriflunomide on the basis of annualized relapse rate (ARR)
研究设计
- 分配方式
- Randomized
- 主要目的
- Teriflunomide Arm
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Expanded Disability Status Scale score (EDSS) of 0.0-5.5 at screening
- •A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria
- •Neurologically stable for at least 30 days prior to randomization and baseline assessments
- •Ability to complete the 9-HPT for each hand in < 240 seconds
- •Ability to perform the timed 25-Foot Walk Test in <150 seconds
- •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
- •A diagnosis of PPMS or non-active secondary progressive Multiple sclerosis (SPMS)
- •Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0
- •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
- •History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
- •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
- •Any concomitant disease that may require chronic treatment with systemic corticosteroids, or immunosuppressants during the course of the study
研究组 & 干预措施
Fenebrutinib, Fenebrutinib
Test
干预措施: Fenebrutinib (Drug)
AUBAGIO 14 mg film-coated tablets
Test
干预措施: AUBAGIO 14 mg film-coated tablets (Drug)
Aubagio Placebo
Placebo
干预措施: Aubagio Placebo (Drug)
Fenebrutinib Placebo
Placebo
干预措施: Fenebrutinib Placebo (Drug)
结局指标
主要结局
1.Annualized relapse rate
1.Annualized relapse rate
次要结局
- 1. Time to onset of cCDP12
- 2. Time to onset of CDP12
- 3. Time to onset of cCDP24
- 4. Time to onset of CDP24
- 5. Total number of gadolinium-enhancing lesions on T1-weighted MRI lesions as detected by MRI
- 6. Total number of new and/or enlarging T2-weighted lesions as detected by MRI
- 7. Rate of percent change in total brain volume from Week 24 as assessed by MRI
- 8. Rate of change from baseline in patient-reported physical impacts of MS, as measured by the Multiple Sclerosis Impact Scale (29-Item), Version 2 (MSIS-29 v2) physical scale
- 9. Time to onset of 12-week confirmed 4-point worsening in SDMT score
- 10. Change from baseline to Week 48 in the concentration of serum neurofilament light chain (NfL)
- 11. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment discontinuation or dose interruptions
- 12. Change from baseline in targeted vital signs
- 13. Change from baseline in targeted ECG parameters
- 14. Change from baseline in clinical laboratory results
- 15. Proportion of patients with suicidal ideation or behavior
- 16. Plasma concentration of fenebrutinib at specified timepoints
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (35)
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