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New treatment option for Generalized Myasthenia Gravis (gMG)
Official title Zilucoplan for Severe gMG Exacerbations
ClinicalTrials.gov ID: NCT07215949
What this study is testing
What is Zilucoplan®?
Zilucoplan® is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for generalized myasthenia gravis (gmg).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 18 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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...
- Completed or updated meningococcal vaccination or initiated meningococcal vaccination with appropriate antibiotic prophylaxis according to current USPI and ACIP guidelines
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.