Phase 3 Myasthenia Gravis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You (or your child's legal guardian) must be able to understand the study requirements and sign a consent form agreeing to take part
• The participant must be between 2 and 17 years old at the time of joining the study
• The participant must have been diagnosed with generalised Myasthenia Gravis, confirmed by a physical exam and a blood test showing specific antibodies (anti-acetylcholine receptor antibodies)
• The participant must have tried treatments such as immune-suppressing drugs, steroids, or certain muscle-strength medications without satisfactory results, but must currently be on a stable treatment plan for at least 1 month before the study begins
• The participant must agree to use contraception as required by local guidelines, and anyone who could become pregnant must have a negative pregnancy test before joining and before receiving the study drug

Who may not be able to join:

• Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study
• Participants whose muscle weakness is getting worse due to a current infection or a medication they are taking
• Participants who have previously tried plasma exchange (a blood-filtering treatment) and it did not help
• Participants who received a live vaccine within 4 weeks before the study screening
• Participants who have had thymus gland surgery within 3 months before screening, or who are planning to have that surgery during the study
• Participants who have another autoimmune disease or other medical condition that could interfere with assessing their Myasthenia Gravis symptoms or put them at extra risk
• Participants with a history of cancer, unless fully treated with no signs of return for at least 3 years (some types of minor skin or localised cancers may still be eligible — confirm with trial site)
• Participants with a significant active infection, or who test positive at screening for Hepatitis B, Hepatitis C, or HIV
• Participants who test positive for COVID-19 (SARS-CoV-2) at screening
• Participants who have had major surgery within 3 months before screening, or who plan to have major surgery during the study
• Participants who have taken part in another clinical trial and received a study drug within the past 12 months, or who are currently in another interventional clinical trial
• Participants who have previously taken part in a clinical trial specifically for the drug efgartigimod and received at least one dose
• Participants who are known to be allergic to the study drug or any of its ingredients
• Participants with a current or past history of alcohol, drug, or medication misuse, as assessed by the study doctor
• Participants taking certain other medications before the study (confirm with trial site for the full list)

Important: Always verify eligibility with the trial site directly before applying.