EUCTR2020-005899-36-BE进行中（未招募）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
- 进行中（未招募）
- 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
- •6. Participants with history of confirmed Progressive Multifocal
- •Leukoencephalopathy (PML) or Neurological symptoms consistent with
- •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
- •therapies, such as rituximab, ocrelizumab or ofatumumab, prior to
- •19. History or current diagnosis of significant ECG abnormalities
- •20. Resting QTcF =450 msec (male) or =460 msec (female) at pre
- •(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
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研究者
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