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:

• People who are at least 18 years old.
• People who have been diagnosed with generalized myasthenia gravis (a condition where the immune system affects muscle control) at a moderate to severe level, based on a standard medical grading scale (grades 2–4), as assessed at the time of screening.
• People whose myasthenia gravis significantly affects daily activities, based on a score of 6 or higher on a standard symptom questionnaire.
• People who, in the investigator's judgment, need immune-suppressing medications, and whose dose of those medications has been stable for at least 8 weeks before the study start visit.
• People taking corticosteroids (such as prednisone) at a daily dose no higher than the equivalent of 40 mg of prednisone, with that dose stable for at least 8 weeks before the study start visit.
• People who have a specific type of antibody related to myasthenia gravis (anti-nAChR or anti-AChR cluster antibody) recorded above the normal upper limit within the past 10 years.
• People who are willing and able to attend all required study visits.
• People who are able to give written informed consent.
• Women who could become pregnant must agree to use highly effective contraception from the screening visit until 14 days after the last dose of the study treatment (Descartes-08).

Who may not be able to join:

• People with a serious ongoing illness that is not well controlled and that the investigator believes could increase health risks during the study.
• People who were first diagnosed with generalized myasthenia gravis within the 12 months before screening.
• People who have never received any systemic (whole-body) treatment for myasthenia gravis other than acetylcholinesterase inhibitor medications (a common type of MG medication).
• People who have another neuromuscular disease in addition to, or instead of, myasthenia gravis.
• People who are pregnant or breastfeeding.
• People who have received intravenous immunoglobulin (IVIG) or plasma exchange treatment within 4 weeks before the study start visit.
• People who have received certain immune-related medications — including rituximab or ocrelizumab within the past 12 months, or calcineurin inhibitors, neonatal Fc receptor antagonists, or other biologics within certain timeframes before the study — (confirm with trial site for exact timing details).
• People who have only recently started a specific type of medication called a C5a inhibitor (such as eculizumab) within 8 weeks before the study start visit. People who have been taking a C5a inhibitor for more than 8 weeks and meet all other criteria may still be considered eligible by the trial site.
• People who have previously received any treatment specifically targeting a protein called BCMA, such as certain antibody therapies or CAR-T cell therapies.
• People with certain abnormal blood clotting test results, or who are taking blood-thinning medications, unless specific exceptions apply as determined by the investigator (confirm with trial site).
• People with a low level of certain white blood cells (neutrophils) below 1,000 cells per microlitre.
• People with a haemoglobin level below 8.0 g/dL, indicating significant anaemia.
• People with a low platelet count, below 50,000 per mm³.
• People with significantly elevated liver enzyme levels (more than 3 times the upper limit of normal).
• People with significantly reduced kidney function (creatinine clearance below 30 mL/min).
• People with a history of a primary immune system deficiency, or who have had an organ transplant or bone marrow transplant from a donor.
• People who test positive for hepatitis B surface antigen.
• People who test positive for hepatitis C antibody and are found to have active hepatitis C virus in the blood.
• People with a history of HIV infection, or who test positive for HIV at screening.
• People with active tuberculosis or a positive tuberculosis screening test (QuantiFERON) at the time of screening.
• People with any other clinical or laboratory finding that the investigator believes could make participation unsafe or affect study results.
• People with active, significant, or uncontrolled heart or lung disease, as judged by the principal investigator. (Note: people with asthma or COPD that is well controlled with inhaled medications may still be considered eligible by the trial site.)
• People with a history of cancer that required treatment within the past 3 years, with some exceptions such as certain skin cancers or early-stage cancers that were surgically removed without requiring chemotherapy or radiation.
• People who have taken part in another clinical trial or received an investigational treatment within 4 weeks before screening, or within 5 half-lives of that treatment, whichever is longer.
• People who have received a live vaccine within 4 weeks before the study start visit, or who plan to receive a live vaccine during the study. (Note: mRNA vaccines such as COVID-19 vaccines are not considered live vaccines for this purpose.)
• People with a history of frequent serious infections, or who have an active infection that the investigator believes could interfere with participation.
• People with a known psychiatric condition that the investigator believes could interfere with participation in the study.

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