Phase 3 Myasthenia Gravis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 8 and under 18 years old (for US locations only)
- You have been diagnosed with myasthenia gravis (MG) that affects muscles throughout your body, rated at a moderate to severe level based on a standard medical classification system
- A blood test has shown you have specific antibodies (anti-AChR or anti-MuSK) linked to myasthenia gravis
- You are using herbal remedies, traditional medicines, nutritional supplements, or prescription medical marijuana, as long as the trial doctor approves and you keep the dose the same throughout the study
- Your veins are suitable for receiving the study drug through an IV drip and for regular blood draws
- Your body weight and body mass index (BMI) fall within the normal range for your age and sex; if you are above or below that range, you may still be able to join after a medical check
- If you are a female who could become pregnant, you must have a negative pregnancy test both at your first screening visit and on the first day of treatment
Who may not be able to join:
- You have a serious or poorly controlled condition affecting your liver, gut, kidneys, lungs, heart, mental health, nervous system, muscles or joints, diabetes, or blood clotting problems (such as a history of blood clots, certain inherited clotting disorders, or an irregular heartbeat) — or your screening blood tests show significant abnormalities
- You have a confirmed or suspected immune system deficiency unrelated to your myasthenia gravis treatment, or there is a family history of an inherited immune condition (unless it has been confirmed you do not have it)
- You have had your thymus gland removed within the past 12 months, or you are planning to have it removed during the main treatment period of the study
- You have previously had a severe allergic reaction (such as anaphylaxis) to a therapeutic protein-based medicine, such as a monoclonal antibody treatment
- You have had a heart attack, unstable heart disease, or a stroke within the 12 weeks before screening
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Phone: 844-434-4210
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change from Baseline in Total Serum Immunoglobulin-G (IgG) Levels; Number of Participants with Infectious Adverse Events (AEs); Number of Participants with Serious AEs (SAEs); Number of Participants with Adverse Events of Special Interests (AESIs); Number of Participants with Abnormalities in Clinical Laboratory Tests; Number of Participants with Abnormalities in Vital Signs; Number of Participants with Abnormalities in Physical Examination; Serum Concentration of Nipocalimab over Time; Clearance (CL) of Nipocalimab; Volume of Distribution (V) of Nipocalimab; Half-life (t1/2) of Nipocalimab; S...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.