BridgeMD
A study to learn if a Zilucoplan auto-injector is safe and works in adults with myasthenia gravis
EU CTIS ID: 2023-508287-30-00
What this study is testing
To evaluate the effectiveness of zilucoplan-auto-injector (ZLP AI) self administration.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
- Capable of giving signed informed which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG), based on study participant's history and supported by previous evaluations.
- Study participant is currently participating in zilucoplan (ZLP) study MG0011 or is administering commercial ZLP on a stable dosing regimen for at least 1month 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.
You likely can't join if
- 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 MG0009, MG0010, or MG0011, which are not excluded, unless the participant was required to withdraw from said studies for a safety reason which could reasonably recur).
See the full eligibility criteria
Who can join
- 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).
- Capable of giving signed informed which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG), based on study participant's history and supported by previous evaluations.
- Study participant is currently participating in zilucoplan (ZLP) study MG0011 or is administering commercial ZLP on a stable dosing regimen for at least 1month 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 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. 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.
What rules you out
- 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 MG0009, MG0010, or MG0011, 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).
The study team makes the final eligibility decision.
Where it's taking place
- 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 EU CTIS; the study team decides eligibility.