A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis ( )

未提供0 个研究点目标入组 12 人开始时间: 待定

适应症

试验速览

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•Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF).
•Participant must have received at least 1 dose of investigational medicinal product (IMP) (rozanolixizumab or placebo) in MG
•Participant for whom the investigator considers a favorable benefit/risk for participation.
•Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgment of the investigator.
•Male or female.
•A female participant is eligible to participate if she is not pregnant, not breastfeeding (including pumping breast milk to feed a child), 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 for the entire study period.
•Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

•Participant meets any of the withdrawal criteria defined in MG
•Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry.
•Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab.
•Participant has been administered prohibited immunosuppressive medications, biologics, or other therapies.
•Participant has planned use of prohibited medications.

发起方

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