Phase 2 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:

• A parent or legal guardian has given permission for the child to take part, and the child has also agreed to join (where required by local rules).
• The participant is between 2 and 17 years old on the day they enroll.
• The participant has been diagnosed with generalized Myasthenia Gravis (gMG), confirmed by a positive blood test for specific antibodies (anti-AChR or anti-MuSK), plus at least one other supporting finding such as an abnormal nerve/muscle test, a positive response to a specific diagnostic test, noticeable improvement on certain medications, or symptoms that clearly fit the condition.
• The participant's condition falls into a moderate-to-severe category (Class II, III, or IV) based on a standard MG severity scale, checked at the start of the study.
• The participant is currently taking either steroids alone, one approved non-steroidal immune-suppressing medication (azathioprine, mycophenolate mofetil, or mycophenolic acid), or a combination of both — and their doses have been stable for a set period of time before joining.
• In Japan only, the medication tacrolimus is also allowed if it has been used continuously for at least 6 months with no dose increase in the last 4 months.
• If the participant takes pyridostigmine (a medication for MG symptoms), the dose must have been stable for at least 2 weeks before enrolling.
• The participant's basic health measurements and blood test results are normal, or any abnormalities are considered not medically significant by the study doctor.

Who may not be able to join:

• People who work for the study sponsor, the research organization running the trial, the study site, or their close family members.
• The participant had their thymus gland removed within the past 12 months, or has plans to have it removed during the study.
• The participant has a thymoma (a tumor near the thymus) that has not been surgically removed — those with a non-cancerous thymoma removed more than 12 months ago may still be eligible.
• The participant has a history of frequent or recurring serious infections.
• The participant has a known immune system disorder, an active infection, or tests positive for HIV.
• The participant tests positive for chronic hepatitis B at the start of the study.
• The participant has a history of untreated hepatitis C, or tests positive for hepatitis C antibodies.
• The participant has a history of active or inactive tuberculosis (TB), or tests positive for TB at screening, unless they have already completed full TB treatment according to local guidelines.
• The participant has a history of a serious brain condition called progressive multifocal leukoencephalopathy (confirm with trial site).
• The participant has a congenital (present from birth) form of myasthenic syndrome rather than the acquired form of MG.
• The participant has received certain B-cell-depleting biologic treatments (such as rituximab or similar medicines) within the past 6 months.
• The participant has received any other monoclonal antibody or large-molecule biologic drug — including FcRn inhibitors, anti-TNF, anti-JAK, or complement inhibitor medications — within the past 6 months.
• The participant has ever received any of the following treatments at any point before joining: alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or natalizumab.
• The participant is currently pregnant, breastfeeding, or planning to become pregnant.

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