EUCTR2018-003618-41-GB进行中（未招募）1 期
An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
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. Has completed the M281 POC study (ie, participated in the POC study without discontinuing study drug for reasons other than the need for rescue therapy as specified in the POC protocol, and completed the protocol-specified 8 weeks of follow-up after the last dose of study drug) and had no major eligibility deviations or other major protocol deviations in the POC study. If the patient received rescue therapy during the POC, the Medical Monitor should be consulted before the patient is enrolled in the OLE study.
- •2. Has sufficient venous access to allow drug administration by infusion and blood sampling as per this OLE protocol.
- •3. Is up to date on all age-appropriate vaccinations as per routine local medical guidelines.
- •4. Women of childbearing potential, defined as women physiologically capable of becoming pregnant, must have a negative urine pregnancy test predose on OLE study Day 1. Menopausal women who did not have elevated follicle-stimulating hormone (FSH) at the time of enrollment in the POC study must also have a negative urine pregnancy test predose on OLE study Day 1.
- •5. Women of childbearing potential (including menopausal women who did not have elevated FSH at the time of enrollment in the POC study) must agree to remain totally abstinent (ie, refrain from sexual intercourse during the study) or to consistently use a reliable and highly effective method of contraception (eg, condom plus diaphragm, condom plus spermicide, diaphragm plus spermicide, or intrauterine device or oral/injectable/implanted hormonal contraceptive used in combination with an additional barrier method) during the OLE study and for 30 days after the last M281 infusion. Note: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
- •6. Male patients must agree to remain totally abstinent (ie, refrain from sexual intercourse during the study) or to consistently use a reliable and highly effective method of contraception (eg, condom plus diaphragm, condom plus spermicide, diaphragm plus spermicide, or intrauterine device or oral/injectable/implanted hormonal contraceptive used in combination with an additional barrier method) to avoid pregnancy of the patient’s partner(s) during the OLE study and for 100 days following the last M281 infusion, unless the patient provides documentation of a vasectomy at least 6 months prior to OLE study enrollment. Male patients must also abstain from sperm donation during the OLE study and for 100 days following the last M281 infusion. Note: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
- •7. A patient using herbal, naturopathic, and traditional Chinese remedies and ayurvedic and nutritional supplements is eligible if the use of these medications is acceptable to the Investigator. These remedies should be at a stable dose and regimen using the same preparation since enrollment in the POC study.
- •8. Is able to understand and voluntarily provide written informed consent to participate in the long-term OLE study and comply with all study procedures for duration of the OLE study.
- •Are the trial subjects under 18?
排除标准
- •1. Has Myasthenia Gravis Foundation of America (MGFA) Class IVb or V disease.
- •2. Met any of the stopping criteria in the POC study or discontinued study drug in the POC study for any reason (eg, adverse event [AE]) other than the need for rescue therapy as specified in the POC protocol. (If the patient received rescue therapy during the POC, the Medical Monitor should be consulted before the patient is enrolled in the OLE study.)
- •3. Has current suicidal ideation or suicidal behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS) administered predose on OLE study Day 1.
- •4. Currently has a serious or clinically significant infection (eg, pneumonia, biliary tract infection, diverticulitis, Clostridium difficile infection) requiring parenteral anti-infectives and/or hospitalization. Note: An uncomplicated, presumably viral, upper respiratory tract infection (eg, ‘the common cold’) is not an exclusion.
- •5. Has current alcohol/substance abuse/dependence, or in the Investigator’s opinion, shows evidence of ongoing alcohol/substance abuse/dependence.
- •6. Has donated or had significant loss of whole blood (480 mL or more) within 30 days, or plasma
- •within 14 days prior to OLE study Day 1.
- •7. Has a hypersensitivity to M281 or any constituent of the study drug solution.
- •8. Has had a prior severe drug reaction that included shock or severe hypersensitivity.
- •9. Has liver impairment with Child-Pugh Class B or C.
- •10. Has any other medical condition(s) likely to require treatment with oral or parenteral glucocorticosteroids (eg, severe asthma), or has required oral or parenteral glucocorticosteroids in the past 3 months before OLE study Day 1 for conditions other than MG (inhalational, intra-articular, topical or ocular glucocorticosteroids are not exclusionary), or taking any immunosuppressive agents not being used to treat MG.
- •11. Is receiving a systemic biologic antibody for any concurrent disease.
- •12. Has a QT interval corrected for heart rate (QTc) at OLE study Day 1 of >450 msec for males or >470 msec for females; or QTc >480 msec in patients with Bundle Branch Block, by the Fridericia formula.
- •13. Had any of the following abnormal laboratory values based on the safety laboratory tests
- •done at the Day 85 POC Visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase =2× upper limit of normal (ULN); or bilirubin =1.5×ULN (isolated bilirubin greater than 1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%, or if there is a prior diagnosis of Gilbert disease without any condition that causes elevation of bilirubin).
- •14. Had elevated CK =2×ULN based on the safety laboratory tests done
- •at the Day 85 POC Visit.
- •Note: If the CK value is =2×ULN at the Day 85 POC visit, the value from
- •the Day 113 POC Visit can be used to assess eligibility. If the value from
- •the Day 113 POC Visit is also =2×ULN, but <5×ULN, and in the opinion of
- •the investigator the patient has no CK related disease and CK level is
- •believed to be the result of non-pathologic factors, the CK may be
- •repeated once within 28 days and if stable/improved the patient can be
研究者
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