NCT07215949 Zilucoplan for Severe gMG Exacerbations
| NCT ID | NCT07215949 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Miriam Freimer |
| Condition | Generalized Myasthenia Gravis (gMG) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 15 participants in total. It began in 2026-01-20 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * History of meningococcal disease * Participants requiring intubation prior to study start. * Recent significant infections which could have caused exacerbation e.g. sepsis and wound infections * Pregnancy or lactating * 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 * Initiation of plasma exchange or IVIG in the past 4 weeks * Participation in concurrent clinical trial with a therapeutic medication * Rituximab use in the previous 9 months * 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
Contact & Investigator
Miriam Freimer, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT07215949 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Generalized Myasthenia Gravis (gMG). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07215949 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 15 participants.
Is NCT07215949 currently recruiting?
Yes, NCT07215949 is actively recruiting participants. Contact the research team at Julie.Agriesti@osumc.edu for enrollment information.
Where is the NCT07215949 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07215949 clinical trial?
NCT07215949 is sponsored by Miriam Freimer. The principal investigator is Miriam Freimer, MD at Ohio State University. The trial plans to enroll 15 participants.