EUCTR2019-004857-10-PT进行中（未招募）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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 736
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
- •Age 18-55 years
- •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
- •For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 8 weeks after the final dose of study medication, and until the teriflunomide elimination protocol is completed
- •For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment phase, for 8 weeks after the final dose of study drug, and until completion of the teriflunomide elimination protocol. Men must also refrain from donating sperm during this same period
- •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.
- •Patients randomized to the teriflunomide treatment arm during the DBT phase must undergo the ATEP prior to the first administration of open-label fenebrutinib
- •For female participants of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, the OLE treatment phase and for 28 days after the final dose of open-label fenebrutinib. Women must also refrain from donating eggs during this same period
- •For male participants: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment phase, OLE treatment phase and for 28 days after the final dose of open-label fenebrutinib to avoid exposing the embryo. Men must also refrain from donating sperm during this same period
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 736
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A diagnosis of PPMS or non-active 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
- •History of alcohol or other drug abuse within 12 months prior to screening
- •Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period
- •Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
- •Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 8 weeks (with ATEP) after final dose of study drug
- •Male participants intending to father a child during the study or 8 weeks (with ATEP) after final dose of study drug
- •Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's
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