Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT04951622) looked at a medicine called nipocalimab in people with myasthenia gravis — a condition that causes muscle weakness affecting everyday activities like talking, chewing, swallowing, and breathing. The trial had two stages: a 24-week "double-blind" phase (where neither participants nor researchers knew who was getting the real medicine or a dummy treatment called a placebo), followed by an open-label extension phase lasting up to two years where all participants received nipocalimab. In total, 99 people started in the placebo group and 100 in the nipocalimab group during the first stage. In the extension phase, a further 196 participants across several groups were enrolled, though completion data for that phase was not reported. The reported data shows that the main thing being measured was change in a symptom score called the MG-ADL — a scale from 0 to 24 where a higher number means more severe symptoms. Scores were recorded at weeks 22, 23, and 24 and averaged together. The placebo group's average score fell by 3.25 points from their starting score, while the nipocalimab group's average score fell by 4.70 points from their starting score. For the secondary outcome measures — including other symptom scores and the proportion of people who reached certain improvement thresholds — the reported data shows that no numerical results were submitted for those measures on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 42084498) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
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 have been diagnosed with myasthenia gravis (MG) that affects muscles throughout your body, and your condition falls into a moderate-to-severe category based on a standard medical classification system
- Your MG symptoms are significantly affecting your daily life, scoring 6 or higher on a standard MG daily living questionnaire at the start of the trial
- Your veins are suitable for receiving the study drug through a drip (IV) and for having blood drawn during the trial
- If you are a woman who could become pregnant, you must test negative for pregnancy both at the initial screening and on the first day of treatment
- If you are a man, you must agree not to donate sperm during the study and for at least 90 days after your last dose of the study drug
- For a specific part of the trial (SC Substudy): You have a suitable area of skin on your abdomen for receiving injections under the skin
- For a specific part of the trial (SC Substudy): You are willing to keep your current dose of steroids and/or immune-suppressing medicines stable for the first 8 weeks of that part of the study
Who may not be able to join:
- You have a confirmed or suspected immune system deficiency that is not caused by your MG treatment, or you have a family history of an inherited immune system condition (unless confirmed that you do not have it)
- Your MG only affects your eyes (Class I), you are in or have recently had an MG crisis within the past month (Class V), or your muscle weakness has become permanent and no longer changes
- You have had your thymus gland removed within the past 12 months, or you are planning to have it removed during the study
- You have a known allergy or sensitivity to the study drug (nipocalimab) or any of its ingredients
- You have had a heart attack, unstable heart disease, or a stroke within the past 12 weeks
- For a specific part of the trial (SC Substudy, Cohort 1): You have recently reduced the amount of MG medication you take during an earlier part of the study
- For a specific part of the trial (SC Substudy, Cohort 1): Your MG condition has been getting worse in the month before starting this part of the study, to a degree that meets certain worsening criteria (confirm with trial site)
- For a specific part of the trial (SC Substudy, Cohort 2): You have had a blood clot in your lungs (without a clear cause) within the past year, or you have had repeated blood clots in your veins
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
Australian sites
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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24; Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57); Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)
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.