New Auto-Injector lets MG patients Self-Dose at home
NCT ID NCT06471361
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether people with generalized myasthenia gravis (gMG) can safely and effectively use an auto-injector to give themselves the drug zilucoplan at home. Thirty-one adults who were already on a stable dose of zilucoplan took part. The main goal was to see if they could deliver the full dose correctly each time, with safety and tolerability also monitored.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zilucoplan
- What this could lead to
- If successful, this could make it easier for people with generalized myasthenia gravis to self-administer their medication at home, improving convenience and independence.
- What could go wrong
- This is a small, completed Phase 3 study focused on device usability, not on proving the drug works. The results may not apply to all patients, and self-injection errors could still occur.
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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31 people
The number who actually took part.
- Started
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Aug 2024
- Finished
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Feb 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: * Study participant is male or female and must be at least 18 years of age at the time of signing the informed consent form (ICF). * Study participant must have a documented diagnosis of gMG, based on study participant's history and supported by previous evaluations. * Study participant is currently participating in ZLP (zilucoplan) study RA101495-02.302 (NCT04225871) or is administering commercial ZLP on a stable dosing regimen for at least 1 month prior to Screening. * Study participants on commercial ZLP need to receive ZLP per the approved local labeling. * Study participant is considered reliable and capable of adhering to the study protocol (eg, able to understand and complete questionnaires and able to adhere to the visit schedule) according to the judgement of the Investigator. * Study participant is willing and capable of self-administering ZLP using the zilucoplan-auto-injector (ZLP AI) according to the instructions for use (IFU), ie, does not have any visual, physical, or other disability or impairment that interferes with his/her capacity to self-administer; if the participant has a caregiver, he/she may assist the participant with the injection. * Vaccination with a quadrivalent meningococcal vaccine and, where available, meningococcal serotype B vaccine at least 14 days prior to investigational medicinal product (IMP) administration, if not vaccinated within 3 years prior to the start of treatment. Booster vaccination(s) should also be administered as clinically indicated, according to the local standard of care, for participants who have been previously vaccinated against Neisseria meningitidis. * Female participants of childbearing potential must have a negative urine pregnancy test prior to the first dose of study drug. * Male and/or female study participants 1. A male participant must agree to use contraception during the Treatment Period and for 40 days after the last dose of study medication, and refrain from donating sperm during this period. 2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance the Treatment Period and for 40 days after the last dose of study medication. * Capable of giving signed informed which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Exclusion Criteria: * Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. * Female participants who are breastfeeding, pregnant, or plan to become pregnant during the study. * Study participant has a known hypersensitivity to any components of the study medication (and/or an investigational device) as stated in this protocol. * Study participant has a clinically relevant active infection or a history of serious infection (resulting in hospitalization or requiring intravenous antibiotic treatment) within 6 weeks before Visit 1. * Study participant has a history of meningococcal disease. * Participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study (except studies RA101495-02.201 (NCT03315130), RA101495-02.301 (NCT04115293), or RA101495-02.302 (NCT04225871), which are not excluded, unless the participant was required to withdraw from said studies for a safety reason which could reasonably recur). * Participant has participated in another study of an IMP (and/or an investigational device) different from ZLP within the previous 3 months or 5 half-lives, whichever is longer, or is currently participating in another study of an IMP (and/or an investigational device). * Current unstable liver or biliary disease at Screening (Visit 1), per Investigator assessment, defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: with exception of stable hepatobiliary conditions (including Gilbert's syndrome, asymptomatic gallstones).
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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.
Contacts and locations
Locations
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Dv0013 40605
Poznan, Poland
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Dv0013 40609
Katowice, Poland
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Dv0013 40759
Krakow, Poland
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Dv0013 40760
Oxford, United Kingdom
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Dv0013 50555
Austin, Texas, 78759, United States
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Dv0013 50556
Chapel Hill, North Carolina, 27599, United States
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Dv0013 50628
New Haven, Connecticut, 06511, United States
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Dv0013 50634
Tampa, Florida, 33612, United States
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Dv0013 50635
Columbus, Ohio, 43221, United States
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Dv0013 50636
Greenfield, Wisconsin, 53228, United States
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Dv0013 50648
Columbia, Missouri, 64212, United States
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