Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis
- Conditions
- Generalized Myasthenia GravisMedDRA version: 21.1Level: PTClassification code: 10028417Term: Myasthenia gravis Class: 100000004852Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-504152-97-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 229
RANDOMIZED PHASE: =18 years of age at the time of consent, and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place., RANDOMIZED PHASE: A woman of childbearing potential must have a negative highly sensitive serum (ß-human chorionic gonadotropin [ß-hCG]) at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention., RANDOMIZED PHASE: Criterion modified per Amendment 1. 11.1 A woman must be (as defined in Section 10.6, Appendix 6, Contraceptive and Barrier Guidance) a. Not of childbearing potential b. Of childbearing potential and - Practicing a highly effective, preferably user-independent method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 30 days after last dose - the end of relevant systemic exposure. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention., RANDOMIZED PHASE: 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., RANDOMIZED PHASE: 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)., RANDOMIZED PHASE: 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., RANDOMIZED PHASE: 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., RADOMIZED PHASE: Must be able to read and write., OLE PHASE: The investigator has confirmed that the participant is not receiving, or has not received since the interruption of the Phase 2 study, any medication that might put the participant at risk when receiving nipocalimab or might interfere with the assessment of the safety of nipocalimab., OLE PHASE: Randomized inclusion point 6, OLE PHASE: Randomized inclusion point 7, RANDOMIZED PHASE: 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.), OLE PHASE: Is recommended to be up to date on all age-appropriate vaccinations prior to screening as per routine local medical guidelines. It is strongly recommended to have COVID-19 vaccination at least 2 weeks before the study visits., OLE PHASE: Sex and Contraceptive/Barrier Requirements as outlined in Double-blind Placebo-Controlled Phase
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 musculoskeletal disorder, hypertension, any other medical disorder(s) (eg, diabetes mellitus), or clinically significant abnormalities in screening laboratory, that 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., Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (eg, monoclonal antibodies)., Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening., Is planning to father a child while enrolled in this study or donate sperm within 90 days after the last administration of study intervention., Is currently breastfeeding, pregnant, intends to become pregnant during the study, or is planning egg donation during the study or within 30 days after the last dose of study intervention., History of moderate or severe substance or alcohol use., Is currently taking eculizumab or other novel immune agents, IgG Fc-related protein therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement., Has received, rituximab within 6 months prior to first administration of study intervention. This criterion does not apply to returning Phase 2 participants., 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, Has received plasmapheresis, immunoadsorption therapy, or IVIg within 6 weeks prior to baseline., Has another medical condition that requires oral or parenteral corticosteroids unless the dose has been stable for at least 4 weeks prior to baseline and is expected to remain stable during the study., 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., 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. This criterion does not apply to returning Phase 2 participants., Has previously received nipocalimab. This criterion does not apply to returning Phase 2 participants., Has received an investigational intervention (including investigational vaccines) within 3 months or 5 half-lives (whichever is longer) or used an invasive investigational medical device within 3 months before the planned first dose administration of study intervention, Has a severe infection including opportunistic infections requiring parenteral anti-infectives and/or hospitalization, and/or is assessed as serious/clinically significant by the investigator, within 8 weeks prior to screening. The participant may be rescreened after the 8-week exclusionary period has passed., Has a chronic infection or requires chronic treatment with anti-infectives., Tests positive for hepatitis B virus infection., Is seropositive for antibodies to hepatitis C virus (HCV), unless they satisfy 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method