EUCTR2020-005732-29-DE进行中（未招募）1 期
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults 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
- 190
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
- •RANDOMIZED PHASE:
- •1. =18 years of age at the time of consent (and must meet the legal age of consent).
- •2. Diagnosis of MG with generalized muscle weakness meeting the clinical criteria for gMG as defined by the MGFA Clinical Classification Class II a/b, III a/b, or IVa/b at screening. (Seronegative participants are no longer being recruited; all participants must have a positive serologic test for a gMG-related pathogenic autoantibody (anti-AChR, anti-MuSK and/or anti-LRP4 autoantibodies), confirmed prior to randomization.)
- •3. MG-ADL score of =6 at screening and baseline.
- •4. Has suboptimal response to current stable therapy for gMG according to the investigator.
- •Stable therapy is defined in the protocol.
- •5. A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana is eligible if the use is acceptable to the investigator.
- •6. Participants who have undergone splenectomy must be at least 3 months post resection prior to screening and must be vaccinated as per the United States Center for Disease Control and Prevention annual Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States. (https://www.cdc.gov) OR must be vaccinated as per country- or territory-specific guidelines or local regulations.
- •7. Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol.
- •8. Is recommended to be up to date on all age-appropriate vaccinations prior to screening as per routine local medical guidelines. It is recommended to have COVID-19 vaccination at least 2 weeks prior study visits.
- •9. Criterion removed per Amendment 1.
- •10. A woman of childbearing potential must have a negative highly sensitive serum at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention.
- •11. A woman must be
- •a. Not of childbearing potential
- •b. Of childbearing potential and
- •- Practicing a highly effective, preferably user-independent method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 30 days after last dose. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study intervention.
- •12. A woman must agree not to donate eggs (ova, oocytes), or freeze for future use for the purposes of assisted reproduction, during the study and for a period of 30 days after the administration of study intervention.
- •13. A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for at least 90 days after receiving the last administration of study intervention. In addition, male participants with partners who are a woman of childbearing potential are highly encouraged to inform their partner to use highly effective contraception methods that result in a low failure rate (less than 1% per year).
- •14. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention.
- •15. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to voluntarily participate in the study and comply with all study procedures.
- •16. Must be able to read and write.
- •Participants who have completed the 24-week double-blind pl
排除标准
- •1. Has a history of severe and/or uncontrolled hepatic (eg, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension or, any other medical disorder(s) (eg, diabetes mellitus), or clinically significant abnormalities in screening laboratory, that, in the opinion of the investigator, might interfere with the patient’s full participation in the study, and/or might jeopardize the safety of the participant or the validity of the study results.
- •2. Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant.
- •3. Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or ‘burnt out’ MG).
- •4. Is dependent on gastric tube for nutritional needs or is ventilator-dependent.
- •5. Is actively undergoing radiation or chemotherapy for an unresected thymoma/malignant thymoma.
- •6. Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study.
- •7. Has current or a history of any neurologic disorder other than MG that might interfere with the accuracy of study assessments.
- •8. Currently has a malignancy or has a history of malignancy within 3 years before screening.
- •9. Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the IB).
- •10. Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (eg, monoclonal antibodies).
- •11. Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening.
- •12. Is planning to father a child while enrolled in this study or donate sperm within 90 days after the last administration of IMP.
- •13. Is currently breastfeeding, pregnant, planning pregnancy, or egg donation during the study or within 30 days after the last dose of IMP.
- •14. History of moderate or severe substance or alcohol use
- •15. Is currently taking IgG Fc-related protein therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement.
- •16. Has received, rituximab within 6 months prior to first administration of IMP, except for returning Phase 2 participants.
- •17. 17.1 Has received, or is expected to receive, a live vaccine within 4 weeks prior to screening or has a known need to receive a live vaccine during the study, or within 8 weeks after the last administration of study intervention.
- •18. Has received plasmapheresis, immunoadsorption therapy, or IVIg within 6 weeks prior to baseline.
- •19. Has another medical condition that requires corticosteroids unless the dose has been stable for at least 4 weeks prior to baseline and is expected to remain stable during the study.
- •20. Has another medical condition that requires an immunosuppressive agent unless the medication has been used for at least 6 months, the dose has been stable for at least 3 months prior to baseline and the medication and the dose are expected to remain stable during the study.
- •21. Has previously received nipocalimab. (Not applicable to returning Phase 2 participants)
- •22. Is receiving or has received an investigational intervention (including investigational vaccines) within 3 months or 5 half-lives (whichever i
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