CTIS2023-508287-30-00进行中（未招募）1 期
A MULTICENTER, OPEN-LABEL, OUTPATIENT STUDY TO EVALUATE THE SAFE AND EFFECTIVE USE OF A ZILUCOPLAN AUTO INJECTOR COMBINATION PRODUCT FOR SUBCUTANEOUS SELF-ADMINISTRATION BY STUDY PARTICIPANTS WITH GENERALIZED MYASTHENIA GRAVIS - DV0013
CB Biopharma0 个研究点目标入组 21 人开始时间: 2024年3月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Study participant is male or female and must be at least 18 years of age at the time of signing the informed consent form (ICF)., Capable of giving signed informed which includes compliance with the requirements and restrictions listed in the ICF and in this protocol., Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG), based on study participant's history and supported by previous evaluations., Study participant is currently participating in zilucoplan (ZLP) study MG0011 or is administering commercial ZLP on a stable dosing regimen for at least 1month prior to Screening., Study participants on commercial ZLP need to receive ZLP per the approved local labeling., Study participant is considered reliable and capable of adhering to the study protocol (eg, able to understand and complete questionnaires and able to adhere to the visit schedule) according to the judgement of the Investigator., Study participant is willing and capable of self-administering ZLP using the zilucoplan-auto-injector (ZLP AI) according to the instructions for use (IFU), ie, does not have any visual, physical, or other disability or impairment that interferes with his/her capacity to self-administer; if the participant has a caregiver, he/she may assist the participant with the injection., Vaccination with a quadrivalent meningococcal vaccine and, where available, meningococcal serotype B vaccine at least 14 days prior to investigational medicinal product (IMP) administration, if not vaccinated within 3 years prior to the start of treatment. Booster vaccination(s) should also be administered as clinically indicated, according to the local standard of care, for participants who have been previously vaccinated against Neisseria meningitidis., Female participants of childbearing potential must have a negative urine pregnancy test prior to the first dose of study drug., Male and/or female study participants ?A male participant must agree to use contraception during the Treatment Period and for 40 days after the last dose of study medication, and refrain from donating sperm during this period. ?A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: ?Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance the Treatment Period and for 40 days after the last dose of study medication.
排除标准
- •Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study., Female participants who are breastfeeding, pregnant, or plan to become pregnant during the study., Study participant has a known hypersensitivity to any components of the study medication (and/or an investigational device) as stated in this protocol., Study participant has a clinically relevant active infection or a history of serious infection (resulting in hospitalization or requiring intravenous antibiotic treatment) within 6 weeks before Visit 1., Study participant has a history of meningococcal disease., Participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study (except studies MG0009, MG0010, or MG0011, which are not excluded, unless the participant was required to withdraw from said studies for a safety reason which could reasonably recur)., Participant has participated in another study of an IMP (and/or an investigational device) different from ZLP within the previous 3 months or 5 half-lives, whichever is longer, or is currently participating in another study of an IMP (and/or an investigational device)., Current unstable liver or biliary disease at Screening (Visit 1), per Investigator assessment, defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: with exception of stable hepatobiliary conditions (including Gilbert's syndrome, asymptomatic gallstones).
研究者
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