EUCTR2020-000949-14-DK进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT)
Viela Bio, Inc./Horizon Therapeutics Ireland DAC0 个研究点目标入组 270 人开始时间: 2020年11月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
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
- •1.Diagnosis of MG with anti-AChR or anti-MuSK antibody.
- •2.MGFA Clinical Classification Class II, III, or IV.
- •3.MG-ADL score at the time of screening and randomization between 6 and 10 with > 50% of this score attributed to non-ocular items, or an MG-ADL score = 11.
- •4.QMG score of 11 or greater at the time of screening and at randomization.
- •5.Subjects must be on:
- •a. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
- •b. One allowed non-steroidal IST, with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
- •c. Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.
- •Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.
- •6. 9. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective contraception method from the time of screening and for 6 months after the final dose of IP. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
- •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 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •8. Thymectomy within = 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the RCP.
- •9. Receipt of the following medications or treatments at any time prior to randomization:
- •a. Alemtuzumab
- •b. Total lymphoid irradiation
- •c. Bone marrow transplant
- •d. T-cell vaccination therapy
- •e. Natalizumab
- •10. Receipt of rituximab, ocrelizumab, ofatumumab, obinutuzumab, inebilizumab, or any experimental B-cell depleting agent within the 6 months prior to Day 1, unless the subject has a CD19+ B-cell count = 40 cells/µL according to the central laboratory at screening.
- •11. Receipt of Leflunomide within 1 year prior to Day 1.
- •12. Receipt within the 3 months prior to Day 1:
- •a. Tocilizumab
- •b. Belimumab
- •c. Eculizumab
- •d. Cyclophosphamide
- •e. Ravulizumab
- •f. Neonatal fragment crystallizable (Fc) receptor (FcRn) blockers (efgartigimod alfa)
- •g. Abatacept
- •h. Etanercept
- •i. Mitoxantrone
- •j. Sirolimus
- •13. Receipt within the 4 weeks prior to Day 1:
- •a. Cyclosporine (except eye drops)
- •b. Tacrolimus (except topical) (tacrolimus < 3 mg/day is allowed in Japan only; see inclusion criterion 7C)
- •c. Methotrexate
- •d. Intravenous immunoglobulin (IVIg)
- •e. Plasma exchange (PLEX) treatment
- •f. Thalidomide
- •g. Tofacitinib
- •14. Current use of:
- •a. Corticosteroids (prednisone > 40 mg/day or > 80 mg over a 2-day period, or equivalent dose of other corticosteroids)
- •b. Acetylcholinesterase inhibitors (pyridostigmine > 480 mg/day) or unstable dose in the 2 weeks prior to Day 1
- •c. Azathioprine > 3 mg/kg/day
- •d. Mycophenolate mofetil > 3 g/day or mycophenolic acid > 1440 mg/day
- •e. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
- •15. Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 half-lives of the investigational treatment, whichever is longer, prior to Day 1.
- •16. Receipt of a live attenuated vaccine within 4 weeks prior to randomization. Administration of inactivated (killed) vaccines is acceptable.
- •25. History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV) unless patient is considered to be cured following antiviral therapy and has a HCV viral load below the limit of detection at least 24 weeks after completion of treatment at site or central lab
- •30. Hospitalization for any reason less than 30 days prior to randomization
- •31. Current or recent myasthenia gravis exacerbationdeterioration that has not returned to baseline/resolved within at least 30 days prior to randomization.
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