癌研連線CancerLink
进行中（不再招募） NCT05070858

一项测试 Pozelimab 与 Cemdisiran 联合治疗及 Cemdisiran 单药治疗在成人全身性重症肌无力患者中的安全性及疗效的研究

宫颈癌／妇科肿瘤皮肤癌Phase IIII 期

本研究正在研究名为 pozelimab 和 cemdisiran 的实验性药物，以及 cemdisiran 单药治疗。研究聚焦于全身性重症肌无力（gMG）患者。重症肌无力是一种因神经与肌肉无法正常沟通而导致身体肌肉无力及疲劳的疾病。 本研究旨在了解 pozelimab 与 cemdisiran 联合使用时的疗效，以及 pozelimab 与 ce

适应症：Generalized Myasthenia Gravis

入组条件

纳入标准

  • Male or female participants ≥18 years of age at screening (or ≥ legal age of adulthood based on local regulations, whichever is older)
  • Participant with documented diagnosis of Myasthenia Gravis (MG) based on medical history and supported by previous evaluations as described in the protocol
  • Documented prior history of positive serologic test or a positive result during screening of Anti-acetylcholine Receptor (AChR) antibodies or anti-Lipoprotein Receptor-related Protein 4 (LRP4) antibodies.
  • Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IVa at screening
  • Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥6 at screening. Ocular items should not contribute more than 50% of MG-ADL total score as described in the protocol
  • Currently receiving an acetylcholinesterase inhibitor or documented reason for not using acetylcholinesterase inhibitor therapy per investigator
  • Currently receiving an Immunosuppressive Therapy (IST) for MG, or documented reason why the participant is not taking an IST per investigator
  • If currently receiving an IST, not anticipated to have IST dosage changed before randomization or during Double-Blind Treatment Period (DBTP).
  • Willing and able to comply with clinic visits and study-related procedures, including completion of the primary series of the meningococcal vaccinations required per protocol

排除标准

  • Patients with antibody profile that is only positive for Muscle-Specific tyrosine Kinase (MuSK) (MuSK positivity is based on a documented prior history of positive serologic test for antibodies to MuSK or a positive result during screening
  • History of thymectomy within 12 months prior to screening or planned during the study
  • History of malignant thymoma (patients with stage 1 may be enrolled), or history of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
  • Myasthenic crisis or MGFA Class V within 1 month of screening
  • Not meeting meningococcal vaccination requirements and, at a minimum, documentation of quadrivalent meningococcal vaccination within 5 years prior to randomization and serotype B vaccine (when available) within 3 years prior to randomization as described in the protocol
  • Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) as described in the protocol
  • Participants who require antibiotics for meningococcal prophylaxis and have a contraindication, warning, or precaution precluding the use of penicillin class and penicillin-alternative antibiotics planned to be used for prophylaxis, or a history of intolerance leading to the discontinuation of these antibiotics
  • Positive hepatitis B surface antigen or hepatitis C virus Ribonucleic Acid (RNA) during screening. NOTE: Cases with unclear interpretation should be discussed with the medical monitor
  • History of Human Immunodeficiency Virus (HIV) infection or a positive test at screening per local requirements

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。