EUCTR2020-000949-14-FR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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 252
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. Age = 18 years
- •2. Diagnosis of MG with anti-AChR or anti-MuSK antibody.
- •3. MGFA Clinical Classification Class II, III, or IV.
- •4. MG-ADL score of 6 or greater at screening and at randomization with >50% of this score attributed to non-ocular items.
- •5. QMG score of 11 or greater.
- •6. 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 nonsteroidal 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.
- •7. Females of childbearing potential who are sexually active with a nonsterilized
- •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.
- •8. Non-sterilized males who are sexually active with a female partner of
- •childbearing potential must use a condom from Day 1 for the duration of
- •the study and for 3 months after the last dose of IP. Because male
- •condom is not a highly effective contraception method, it is strongly
- •recommended that female partners of a male study subject also use a
- •highly effective method of contraception throughout this period
- •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 212
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Lactating or pregnant females, or females who intend to become pregnant anytime from signing the informed consent form (ICF) throughout the RCP plus 6 months following last dose of IP.
- •2.Known immunodeficiency disorder, including human immunodeficiency virus (HIV) infection.
- •3.Thymectomy within = 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the RCP.
- •4.Receipt of the following medications or treatments at any time prior to randomization:
- •a.Alemtuzumab (Lemtrada®, Campath®)
- •b.Total lymphoid irradiation
- •c.Bone marrow transplant
- •d.T-cell vaccination therapy
- •e.Natalizumab (Tysabri®)
- •5.Receipt of rituximab (MabThera®, Rituxan®), ocrelizumab (Ocrevus®), ofatumumab (Arzerra®), obinutuzumab (Gazyva®), 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.
- •6.Receipt within the 3 months prior to Day 1:
- •a.Tocilizumab (Actemra®)
- •b.Belimumab (Benlysta®)
- •c.Eculizumab (Soliris®)
- •d.Cyclophosphamide (Cytoxan®)
- •7.Receipt within the 4 weeks prior to Day 1:
- •a.Cyclosporine (except eye drops)
- •b.Tacrolimus (except topical)
- •c.Methotrexate
- •d.Intravenous immunoglobulin (IVIg)
- •e.Plasma exchange (PLEX) treatment
- •8.Current use of:
- •a.Prednisone > 40 mg/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids)
- •b.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
- •9.Receipt of a live attenuated vaccine within 4 weeks prior to randomization. Administration of inactivated (killed) vaccines is acceptable.
- •10.Unresected thymoma (Note: subjects with a benign thymoma resected > 1 year prior to screening may enroll. Benign is defined as no known metastases and no extension into or beyond the capsule on pathological examination. Imaging to evaluate for thymoma must have been performed prior to randomization per standard of care).
- •11.History of cancer, except for the following:
- •a.In situ carcinoma of the cervix treated with apparent success with curative therapy for > 12 months prior to screening
- •b.Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy for > 12 months prior to screening
- •c.Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent > 3 years prior to screening and without known recurrence or current treatment
- •d.Malignant thymoma resected > 5 years prior to screening with no evidence of active disease and no therapy received over the previous 5 years.
- •12.Any of the following laboratory abnormalities at screening (one repeat test may be conducted to confirm results prior to randomization within the same screening period):
- •a.Elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN)).
- •b.Total bilirubin > 1.5 × ULN (unless due to Gilbert’s syndrome)
- •c.Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2
- •d.CD19+ B-cell count < 40 cells/µL
- •e.Absolute neutrophil count (ANC) < 1.2 × 103 cells/µl
- •f.Platelet count < 75,000/µL (or < 75 × 109/L)
- •g.Hemoglobin < 8.0 g/dL
- •h.Total immunoglobulin < 600 mg/dL
- •13.Positive test for chronic hepatitis B infection at screening, defined as either (1) positive hepatitis B surface antigen (HBsAg) or (2) a po
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