EUCTR2021-003772-14-SK进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TOINVESTIGATE THE EFFICACY OF FENEBRUTINIB IN RELAPSING MULTIPLE SCLEROSIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 109
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
- 性别
- All
入选标准
- •Participants who are aged 18 to 55 years inclusive at the time of signing Informed Consent Form
- •A diagnosis of relapsing MS (RMS) in accordance with the revised 2017 McDonald Criteria and one of the following:
- •o 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 screening)
- •o Documented evidence of the presence of at least one T1 Gd+ lesion on MRI in the 6 months prior to randomization (may include the screening MRI)
- •Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points
- •For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs during the treatment period and for 28 days after the final dose of fenebrutinib
- •For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 28 days after the final dose of fenebrutinib to avoid exposing the embryo
- •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 102
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease duration of >10 years from the onset of symptoms and an EDSS score at screening <2.0
- •A diagnosis of primary progressive MS or non-active secondary progressive MS
- •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 or during screening or treatment with oral anti-microbials within 2 weeks prior to or during screening
- •History of progressive multifocal leukoencephalopathy (PML)
- •History of cancer
- •Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy >1 year prior to screening is not exclusionary
- •Presence of other neurological disorders that could interfere with the diagnosis of MS or with the assessments of efficacy or safety during the study
- •Evidence of clinically significant psychiatric, pulmonary, renal, hepatic, metabolic, gastrointestinal (GI), or cardiovascular disease, or endocrine disease
- •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
- •Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT
- •History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- •Participants undergoing dialysis or estimated glomerular filtration rate <60 mL/min/1.73 m^2
- •Any of the following laboratory results: ALT or AST >2*upper limit of normal (ULN); Total bilirubin greater than 1.5*ULN; Hemoglobin <9.5 grams/deciliter; White blood cell count <2000 cells/mm^3 (µL); Platelet count <100*10^9/L; Absolute neutrophil count <=1500 cells/mm^3 (µL); IgG<500 mg/dL
- •Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the 12-week double-blind study period
- •History of alcohol or other drug abuse within 12 months prior to screening
- •Positive screening tests for hepatitis B
- •Positive screening tests for hepatitis C
- •Evidence of active, latent or inadequately treated infection with tuberculosis
- •Clinically significant abnormalities in hepatic synthetic function tests
- •History of hospitalization or transfusion for a GI bleed
- •Known bleeding diathesis
- •Any condition possibly affecting oral drug absorption
- •History of or currently active primary or secondary (non-drug-related) immunodeficiency
- •Inability to complete an MRI scan or contraindication to Gd administration
- •Any previous history of organ transplantation
- •Any previous treatment with bone marrow transplantation or hematopoietic stem cell transplantation
- •Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening or during the screening period. Inhaled and topical corticosteroids are allowed.
- •Receiving an unstable dosing regimen of proton pump inhibitors or H2-receptor antagonist during the screening phase and/or no plan to remain at a stable dose for the duration of study treatment
- •Treatment with IVIg or plasmapheresis within 12 weeks prior to randomization
- •Sensitivity or intolerance to any ingredient of fenebrutinib
- •Receipt of a live-attenuated vaccine within 6 weeks prior to randomization
- •Need for systemic anticoagulation (ora
研究者
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