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 have given written consent before any study activities begin
• People who weigh between 40 and 130 kg at the time of screening
• People diagnosed with generalised myasthenia gravis (a muscle weakness condition), confirmed by a specific antibody test (called AChR antibody) plus at least one supporting test or treatment response (confirm with trial site)
• People whose myasthenia gravis falls within a moderate-to-moderately-severe range, as classified by a standard medical rating system called MGFA Class II–IVa (confirm with trial site)
• People who score 6 or higher on the MG-ADL scale, which measures how the condition affects daily activities
• People who score 10 or higher on the QMG scale, another standard measure of myasthenia gravis severity
• People who have received recommended vaccinations against certain bacteria, in line with local health requirements
• Female participants who are either not able to become pregnant, or who agree to use highly effective contraception, not to donate eggs, and not to attempt pregnancy during the trial
• Male participants who agree not to donate sperm and to use acceptable contraception if their partner could become pregnant

Who may not be able to join:

• People with a significant medical or surgical condition, serious illness, mental illness, or major surgery that could affect safety or the study results
• People with a known deficiency in the complement system (a part of the immune system)
• People who have ever had a meningococcal (N. meningitidis) infection at any point in their life
• People who are known to have, or test positive during screening for, active HIV, hepatitis B (unless immunity is from vaccination), or hepatitis C
• People who have previously been treated with claseprubart (DNTH103) or taken part in another trial of this drug
• People who have had thymic surgery or a thymus biopsy within the past year
• People with a known or untreated thymoma (a type of tumour near the thymus)
• People with any history of thymic carcinoma or malignancy of the thymus
• People with a history of active cancer within the past 5 years, with certain exceptions such as some treated skin cancers, treated cervical carcinoma in situ, or low-grade prostate cancer managed by observation only (confirm with trial site)
• People who have recently used certain immune-suppressing medications, including rituximab or similar B-cell therapies within the past 6 months, or intravenous immunoglobulin (IVIg) or plasma exchange within the past 4 weeks
• People who have participated in another clinical drug trial within the past 90 days or within 5 half-lives of that trial's drug
• People diagnosed with lupus (SLE), or people who have a parent, sibling, or child with lupus

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