Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-24 @ 12:55 PM
NCT ID:
NCT05644561
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period
* Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening
* Participants receiving treatment must be on a stable dosing regimen of adequate duration prior to Screening and during the Screening Period.
* Eculizumab-experienced participants must have been enrolled and treated with eculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have been on a stable dose for ≥ 2 months (60 days) prior to Screening.
* All participants must be vaccinated against meningococcal infection
Exclusion Criteria:
Medical Conditions
* Any untreated thymic malignancy, carcinoma, or thymoma.
* Participants with a history of treated benign thymoma
* History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening
* History of N meningitidis infection
* Known to be human immunodeficiency virus (HIV) positive
* History of unexplained infections
* Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05644561
Study Brief:
Protocol Section:
NCT05644561