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:

• People who have tested positive for specific antibodies linked to Myasthenia Gravis (MG) — called anti-AChR or anti-MuSK antibodies — confirmed through blood tests at the start of the study.
• People who have at least one of the following in their medical history: abnormal nerve-muscle communication test results; a positive test using a drug that temporarily improves MG symptoms; noticeable improvement in MG symptoms when taking oral MG medications; or a pattern of symptoms clearly consistent with MG that cannot be explained by another condition.
• People whose MG is classified as moderately severe to severe (MGFA Class II, III, or IV) at the time of screening.
• People whose MG-ADL score (a measure of how MG affects daily activities) is 5 or higher, with more than half of that score coming from symptoms affecting parts of the body other than the eyes.
• People whose QMG score (a clinical measure of MG severity) is 11 or higher at screening.
• People who are willing and able to follow the study schedule, complete all assessments, and attend follow-up visits.
• Women who could become pregnant and are sexually active with a male partner who has not had a sterilisation procedure must use at least one highly effective form of contraception from the screening visit until 12 months after the last dose of the study treatment. Methods such as the rhythm method, periodic abstinence, or withdrawal are not considered acceptable.
• For the purposes of this trial, women are considered able to become pregnant unless they have had both fallopian tubes tied, both ovaries removed, or a complete hysterectomy, or have gone through menopause (defined as no menstrual periods for 12 months with no other medical explanation).
• Men who have not had a sterilisation procedure and are sexually active with a female partner who could become pregnant must use a condom from Day 1 of the study until 3 months after the last dose of the study treatment. Because condoms alone are not considered highly effective, it is strongly recommended that the female partner also use a highly effective contraception method during this time.

Who may not be able to join:

• People with any other condition that the study doctor believes could put them at unacceptable risk, interfere with the study treatment, or make the results difficult to interpret.
• Women who are pregnant, breastfeeding, or planning to become pregnant from the time of signing the consent form until 6 months after the last dose of study treatment.
• People with a history of drug or alcohol misuse within the past year, or those the study doctor believes may have difficulty following the study requirements.
• People who work at the study site, or their immediate family members.
• People who are currently under a formal or court-ordered institutional commitment.
• People diagnosed with congenital myasthenic syndromes (a form of MG present from birth that is not caused by the immune system).
• People with a known immune deficiency disorder, including HIV infection.
• People who have had their thymus gland removed within the 12 months before the study starts, or who plan to have it removed during the study.
• People who have ever received any of the following treatments: alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or natalizumab.
• People who have ever received any immune-suppressing medication other than corticosteroids (steroids), including but not limited to: azathioprine, mycophenolate, cyclosporine (except as eye drops), tacrolimus (except as a skin cream), methotrexate, cyclophosphamide, tocilizumab, belimumab, eculizumab, rituximab, ocrelizumab, ofatumumab, obinutuzumab, inebilizumab, or any experimental B-cell depleting treatment.
• People who have received intravenous immunoglobulin (IVIg) or plasma exchange treatment within the 4 weeks before Day 1 of the study.
• People currently taking prednisone at a dose below 20 mg per day (or an equivalent low dose of another steroid), or taking pyridostigmine at more than 480 mg per day, or whose pyridostigmine dose has not been stable in the 2 weeks before Day 1.
• People who have taken part in another clinical trial using an experimental treatment within 4 weeks (or 5 half-lives of that treatment, whichever is longer) before Day 1.
• People who have received a live vaccine within 4 weeks before randomisation. Vaccines made from inactivated (killed) viruses or bacteria are acceptable.
• People with a history of severe allergic reactions, including anaphylaxis, to biological medicines, or who are known to be allergic to any ingredient in the study treatment.
• People with a history of frequent serious infections that required hospitalisation or intravenous antibiotics.
• People who have an active infection requiring antibiotic or antifungal treatment within 2 weeks before the screening visit (chronic nail infections are an exception).
• People with a thymoma (tumour of the thymus gland) that has not been surgically removed. People with a benign (non-spreading) thymoma removed more than one year before screening may be eligible (confirm with trial site).
• People with a history of most types of cancer. Some exceptions may apply for certain cancers that were fully treated more than 12 months ago (such as certain skin cancers or early-stage cervical cancer), prostate cancer treated with curative intent more than 3 years ago with no recurrence, or a malignant thymoma removed more than 5 years ago with no signs of active disease (confirm with trial site).
• People who have had a pregnancy end (by any means, including miscarriage or birth) within 4 weeks before screening.
• People with certain abnormal blood test results at screening, including: significantly elevated liver enzymes; high bilirubin levels (unless due to a harmless inherited condition called Gilbert's syndrome); reduced kidney function; low levels of certain immune cells (B-cells or neutrophils); low platelet count; low haemoglobin (anaemia); or low total immunoglobulin levels.
• People who test positive for chronic hepatitis B infection at screening (certain specific patterns of hepatitis B blood markers apply — confirm details with trial site).
• People who test positive for hepatitis C antibodies.
• People who test positive for HIV.
• People who have received a blood transfusion within 4 weeks before screening or during the screening period.
• People who are unable to read.
• People with a history of active or latent (inactive) tuberculosis (TB), or a positive TB screening test, unless they have completed TB treatment according to local guidelines. People currently on TB treatment may be eligible if they have completed at least one month of treatment and plan to finish the full course (confirm with trial site).

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