Tests zilucoplan in adults with severe myasthenia gravis flares needing hospital care
Tests daily zilucoplan injections in adults with severe myasthenia gravis flares needing hospital care.
Plain-language title generated from the registry record
Registry title: Zilucoplan for Severe gMG Exacerbations
Key facts
- Where
- Columbus, Kansas City, and Tampa, United StatesSee the 3 sites
- Phase
- Phase 3
Where in United States
- The Ohio State UniversityColumbus, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesNot yet recruiting
- University of South Florida (Tampa General Hospital)Tampa, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Miriam Freimer
- Trial code
- NCT07215949
- Record updated
- 28 August 2026
- Original description
This is an open-label, multicenter, interventional phase 3b study in participants with AChR+ gMG and severe exacerbation that require hospitalization. Patients will receive subcutaneous zilucoplan injections daily for 12 weeks. Participation in the study will last for approximately 18 weeks.Read full original descriptionShow less
Zilucoplan Treatment of Severe MG Exacerbations Leading to Hospitalization of Participants With Acetylcholine Receptor Antibody Positive gMG
This is an open-label, multicenter, interventional phase 3b study in participants with AChR+ gMG and severe exacerbation that require hospitalization. Patients will receive subcutaneous zilucoplan injections daily for 12 weeks. Participation in the study will last for approximately 18 weeks.
Inclusion: Patient determined to have severe MG exacerbation (e.g. bulbar and/or respiratory symptoms requiring hospitalization, neck extension weakness); MGFA class II - IVb; Male or female aged ≥18; MG-ADL ≥6 in non-ocular domains; Serology - AChR antibody positive (or historically available data); If female of child-bearing potential (i.e., not surgically sterile or post-menopausal defined as age > 51 years without menses for ≥ 2 years), negative serum pregnancy test at screening; Women of child-bearing potential or men with sexual partners of childbearing potential must be willing to use an acceptable method of birth control for the duration of the study and for 40 days after the last dose of study drug therapy. Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, intra-uterine device, the contraceptive ring, and or barrier contraception such as condoms with spermicide; Completed or updated meningococcal vaccination or initiated meningococcal vaccination with appropriate antibiotic prophylaxis according to current USPI and ACIP guidelines.
Exclusion: Participants requiring intubation prior to study start; Recent surgery (<4 weeks). Minor procedures/surgeries allowed at the discretion of the site principal investigator; Current use or known failure of C5 inhibitors in the previous 3 months; Participation in concurrent clinical trial with a therapeutic medication; Rituximab use in the previous 9 months; History of meningococcal disease; Recent significant infections which could have caused exacerbation e.g. sepsis and wound infections; Any clinically significant condition or illness, which, in the opinion of the PI, would pose a risk to the subject or might confound the study; Pregnancy or lactating; Initiation of plasma exchange or IVIG in the past 4 weeks.