New daily shot could tame severe MG attacks
NCT ID NCT07215949
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study tests a daily injection called zilucoplan in 15 people hospitalized with severe myasthenia gravis (MG) flare-ups. The goal is to see if the drug can quickly improve daily living activities, like breathing and swallowing, within two weeks. Participants receive the injections for 12 weeks, and researchers track their progress for about 18 weeks total.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Zilucoplan (a drug given as daily injections under the skin)
- What this could lead to
- If it works, this could provide a new treatment option for severe myasthenia gravis flare-ups, helping people recover faster and avoid prolonged hospital stays.
- What could go wrong
- This is a small, early-phase trial with only 15 participants, so results may not apply to everyone. The drug may not improve symptoms significantly, and daily injections can be inconvenient or cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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University of Kansas Medical Center
NOT_YET_RECRUITINGKansas City, Kansas, 66160, United States
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University of South Florida/Tampa General Hospital
NOT_YET_RECRUITINGTampa, Florida, 33620, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an antibody that blocks a immune protein ease myasthenia gravis?
- Real-World study tracks Efgartigimod's impact on myasthenia gravis symptoms
- New drug combo aims to ease muscle weakness in myasthenia gravis
- 450 russians with rare muscle disease to be tracked in real-world treatment study
- New drug combo aims to ease myasthenia gravis symptoms
- New hope for tough myasthenia gravis cases? eculizumab trial in china