PER-076-20尚未招募未知
A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND,DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATETHE EFFICACY AND SAFETY OF FENEBRUTINIB COMPAREDWITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS.
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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
入选标准
- •Patients must meet the following criteria for study entry:
- •- Signed Informed Consent Form
- •- Age 1855 years inclusive at time of signing the Informed Consent Form
- •- Ability to comply with the study protocol
- •- EDSS score of 05.5 at screening
- •- A diagnosis of RMS* in accordance with the revised 2017 McDonald Criteria (Thompson
- •et al. 2018) and one of the following:
- •a) At least two documented clinical relapses within the last 2 years or one documented
- •clinical relapse within 12 months of screening (but not within the 30 days prior to
- •b) Documented evidence of the presence of at least one T1Gd+ lesion on MRI in the
- •12 months prior to randomization.
- •* RMS may include aSPMS as defined by Lublin 2014.
- •- 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 T25FWT
- •- For women of childbearing potential: agreement to remain abstinent (refrain from
- •heterosexual intercourse) or use contraception, and agreement to refrain from donating
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a
- •condom, and agreement to refrain from donating sperm.
- •See protocol for more detail.
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •- Disease duration of 10 years from the onset of symptoms and an EDSS score at
- •screening 2.0
- •- Pregnant or breastfeeding, or intending to become pregnant during the study or within 8
- •weeks (with ATEP) after the final dose of study drug
- •- Men intending to father a child during the study or within 8 weeks (with ATEP) after final
- •dose of study drug
- •- A diagnosis of PPMS or non-active SPMS
- •- 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
- •- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- •- History of cancer, including hematologic malignancy and solid tumors, within 10 years of
- •- Known presence of other neurological disorders.
- •- Evidence of clinically significant psychiatric, pulmonary, renal, hepatic (including Gilbert
- •syndrome), metabolic, gastrointestinal (GI), or cardiovascular disease (including
- •arrhythmias or QTc prolongation), or endocrine disease (including uncontrolled diabetes,
- •non-gallstone pancreatitis, or chronic pancreatitis) that, in the investigator’s opinion, would
- •preclude patient participation.
- •- Presence of the New York Heart Association Class III and Class IV criteria for congestive
- •heart failure.
- •- Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect
- •patient safety or interpretation of study results, including QT interval corrected through use
- •of Fridericia’s formula (QTcF) 440 ms demonstrated by at least two ECGs 30 minutes
- •- Current treatment with medications that are well known to prolong the QT interval at doses
- •that have a clinically meaningful effect on QT, as determined by the investigator
- •- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias.
- •- Rare hereditary problems of galactose intolerance, total lactase deficiency, or
- •glucose-galactose malabsorption
- •- Hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum
- •albumin 3.0 g/dL
- •- Patients with severe renal impairment undergoing dialysis and/or estimated glomerular
- •filtration rate (eGFR) 60 mL/min/1.73 m2 (may be repeated if eGFR
- •4559 mL/min/1.73 m2).
- •- Severe hepatic disease impairment (Child-Pugh Class C).
- •- Patients with significantly impaired bone marrow function or significant anemia, leukopenia,
- •neutropenia or thrombocytopenia.
- •- Patients with significantly impaired bone marrow function or significant anemia, leukopenia,
- •neutropenia or thrombocytopenia.
- •- Any concomitant disease that may require chronic treatment with systemic corticosteroids
- •or immunosuppressants during the course of the study
- •- History of alcohol or other drug abuse within 12 months prior to screening
- •- Positive screening tests for active, latent, or inadequately treated hepatitis B.
- •See protocol for more detail.
研究者
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