Phase 3 Myasthenia Gravis Trial, Recruiting

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

Who might be able to join this trial:

• The participant (and/or their legal guardian) must be able to understand the trial requirements, provide written agreement to take part, and be willing and able to attend all required visits and follow the trial procedures.
• Children and teenagers aged 2 to under 18 years old at the time of providing consent to join the trial (note: age groups are enrolled in a specific order — the 12–17 age group first, then the 2–11 age group).
• People who have been diagnosed with Generalized Myasthenia Gravis (a muscle weakness condition), with documentation confirming this diagnosis.
• People whose condition falls into certain severity categories as defined by a specialist medical foundation — specifically the moderate to moderately-severe range (confirm with trial site for exact classification).
• People who have not responded well enough to existing treatments such as immune-suppressing medicines, steroids, or medicines that help muscle-nerve communication, and who have been on a stable treatment plan for a sufficient period before the trial screening.
• People who have tested positive for a specific antibody linked to Myasthenia Gravis (called anti-AChR antibody) — for smaller children under 15kg, a past test result may be used.
• People who meet the trial's requirements around contraception, as set by local regulations. Male participants must agree not to donate sperm from the time of providing consent until the trial is completed. Female participants who could potentially become pregnant must have a negative pregnancy test at screening and again at the start of the trial before receiving any study medication.

Who may not be able to join:

• People whose Myasthenia Gravis falls into certain other severity categories — specifically the mildest form affecting only the eyes, or the most severe forms involving significant breathing or swallowing difficulties (confirm with trial site for exact classifications).
• Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 90 days after the last dose of study medication.
• People with a significant active or ongoing bacterial, viral, or fungal infection that is not under control at the time of screening.
• People with another autoimmune disease that, in the treating doctor's opinion, could interfere with assessing the Myasthenia Gravis symptoms or pose additional risks.
• People with a history of cancer, unless they have been successfully treated with no signs of return for 3 or more years — though certain low-risk skin or localised cancers may still be considered eligible (confirm with trial site).
• People with other significant serious health conditions, a recent major operation, or any condition that in the doctor's opinion could affect the trial results or pose undue risk.
• People experiencing worsening muscle weakness due to a current infection or certain medications (such as some antibiotics or blood pressure medicines).
• People who have previously tried a treatment called plasma exchange (PLEX) and had no clinical benefit from it.
• People who have received a live or live-attenuated vaccine within 28 days before the screening visit.
• People who have had their thymus gland removed fewer than 3 months before screening, or who are planning to have it removed during the trial.
• People who test positive at screening for active Hepatitis B, Hepatitis C, HIV, or COVID-19 (SARS-CoV-2).
• People who have recently used certain other treatments, including: another experimental treatment within the past 3 months or 5 half-lives (whichever is longer); any monoclonal antibody therapy within the past 6 months; or intravenous, subcutaneous, or intramuscular immunoglobulin, or plasma exchange within 4 weeks before screening.
• People whose blood immunoglobulin (IgG) levels are below the normal range for their age and sex by a certain threshold at screening (confirm with trial site).
• People with a known allergic reaction to the study drug efgartigimod or any of its ingredients.
• People currently in another clinical trial, or who have previously participated in a trial involving efgartigimod and received at least one dose.
• People with a history of alcohol, drug, or medication misuse within the 12 months before screening, as assessed by the treating doctor.

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