EUCTR2020-005899-36-NL招募中1 期
A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 800
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
- •1. Signed informed consent obtained prior to any assessment performed (confirm at screening visit)
- •2. Male or female participants 18 to 55 years of age (inclusive) at screening
- •3. Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
- •(this would include relapsing-remitting course (RRMS) or secondary progressive (SPMS) course with disease activity) as confirmed at screening visit.
- •4. At least: 1 documented relapse within the previous year, OR 2 documented relapses within the previous 2 years, prior to screening, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months prior to screening
- •5. EDSS score of 0 to 5.5 (inclusive) at screening and randomization
- •6. Neurologically stable within 1 month prior to screening and randomization (including no MS relapse in this period)
- •Please see protocol for complete detailed list of inclusion criteria
- •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 800
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Diagnosis of primary progressive multiple sclerosis (PPMS)
- •2.Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening
- •3.History of clinically significant CNS disease other than MS
- •4.Ongoing substance abuse (drug or alcohol)
- •5.History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer),
- •6.Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML
- •7.suicidal ideation or behavior
- •8.Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary , renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence
- •9.Participants who have had a splenectomy
- •10.Active clinically significant systemic bacterial, viral, parasitic or fungal infections
- •11.Positive results for syphilis or tuberculosis testing
- •12.Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
- •13.Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.
- •14.Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody
- •15.History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or participants with moderate or severe hepatic impairment (Child-Pugh class C) or any chronic liver or biliary disease.
- •16.History of severe renal disease or creatinine level
- •17.Participants at risk of developing or having reactivation of hepatitis
- •18.Hematology parameters at screening:
- •Hemoglobin: < 10 g/dl (<100g/L)
- •Platelets: < 100000/mm3 (<100 x 109/L)
- •Absolute lymphocyte count < 800/mm3 (<0.8 x 109/L)
- •White blood cells: <3 000/mm3 (<3.0 x 109/L)
- •Neutrophils: < 1 500/mm3 (<1.5 x 109/L)
- •B-cell count < 50% lower limit of normal (LLN) or total IgG & total IgM < LLN (only required for participants who had a history of receiving B-cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)
- •19.History or current diagnosis of significant ECG abnormalities
- •20.Resting QTcF =450 msec (male) or =460 msec (female) at pre-treatment (prior to randomization)
- •21.Use of exclusionary medication prior to screening/randomization as defined in the protocol
- •22.Use of other investigational drugs
- •23.Requirement for anticoagulant medication or use of dual anti-platelet therapy
- •24.Significant bleeding risk or coagulation disorders,
- •25.History of gastrointestinal bleeding
- •26.Major surgery within 8 weeks prior to screening
- •27.History of hypersensitivity to any of the study drugs or excipients
- •28.Pregnant or nursing (lactating) female participants, prior to randomization
- •29.Women of childbearing potential not using highly effective contraception
- •30.Sexually active males not agreeing to use condom
- •31.Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study
- •32.Use of strong CYP3A4 inhibito
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