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:

• You must be willing and able to sign a consent form, follow the study's requirements, complete all assessments, and attend follow-up visits.
• You must be 18 years of age or older (male or female).
• You must have been diagnosed with a specific type of myasthenia gravis (MG) called "seronegative MG," meaning your MG symptoms cannot be explained by another condition, nerve-muscle transmission tests showed abnormal results, blood tests were negative for the two most common MG antibodies (AChR and MuSK), and standard treatments have had limited or no effect.
• Your MG must fall into a moderate-to-severe category (Class II, III, or IV) based on a standard medical classification system, confirmed at the time of screening.
• Your MG symptoms must be moderate to severe, as measured by specific scoring tools, and you must report that your condition is not at a satisfactory level, with at least 6 months of recorded history to confirm this.
• Your MG must have stayed the same or gotten worse during a 4-week check-in period before the trial starts.
• You must have been on a stable dose of your current MG medication(s) — such as steroids, azathioprine, methotrexate, or similar drugs — for at least one month before screening.
• If you previously left another trial of the study drug (efgartigimod) early, you may still be eligible, as long as you did not leave due to pregnancy, needing emergency treatment, or a serious safety event.
• If you are a woman who could become pregnant and are sexually active with a male partner who has not been sterilized, you must be willing to use at least one highly effective form of contraception from screening until 3 months after your last dose.
• If you are a man who has not been sterilized and are sexually active with a female partner who could become pregnant, you must be willing to use a condom throughout the study and for 3 months after your last dose.
• Your vital signs, heart test (ECG), and blood/lab results must be within normal ranges at screening, or any abnormalities must be considered not medically significant by the study doctor.
• A blood test within one month of screening must show your IgG (a type of immune protein) level is above 6 g/L (confirm with trial site).
• You must have received a COVID-19 vaccine at least 2 weeks before the screening visit.

Who may not be able to join:

• You previously left a trial of efgartigimod early because of pregnancy, needing emergency rescue treatment, or a serious safety event that was life-threatening or posed a significant risk.
• You are currently pregnant, breastfeeding, or planning to become pregnant during the trial or within 3 months after the last dose.
• You are a male patient who is sexually active and does not plan to use effective contraception during the trial or within 3 months after the last dose, or who plans to donate sperm during this time.
• You have a known infection with hepatitis B, hepatitis C, or HIV.
• You have another autoimmune disease (such as rheumatoid arthritis) that, in the study doctor's opinion, would make it hard to accurately assess your MG symptoms.
• You have another significant medical condition or have recently had major surgery that could affect the trial results or put you at unnecessary risk.
• Your kidneys or liver are not functioning well enough, based on specific blood test thresholds at screening (confirm with trial site).
• You have a known allergy or sensitivity to any ingredient in the study drug, efgartigimod.
• You have received the medications rituximab or eculizumab within the 6 months before screening.
• You have had your thymus gland removed (thymectomy) within 3 months before screening.
• You have received intravenous immunoglobulin (IVIG) or plasma exchange within 4 weeks before screening.
• You have a significant active or ongoing bacterial, viral, or fungal infection at the time of screening.
• You have received a live or live-attenuated vaccine (such as certain flu or shingles vaccines) within one month before screening.

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