Zilucoplan for Myasthenia Gravis
(ziMyG+ Trial)
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: UCB Biopharma SRL
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to assess the long-term safety and tolerability of an additional 52 weeks of Zilucoplan treatment administered by subcutaneous injection once daily in pediatric study participants
Eligibility Criteria
This trial is for pediatric patients with generalized Myasthenia Gravis who are at least 2 years old and have completed the MG0014 study. They must be willing to get booster shots against meningococcal infections if needed.Inclusion Criteria
I am 12 years old or older and can legally consent.
I am at least 2 years old and can legally consent.
I have finished the MG0014 study and, in my doctor's view, should keep taking zilucoplan.
+1 more
Participant Groups
The trial is testing Zilucoplan, a medication given by daily injection under the skin, over an additional year to see how safe and tolerable it is for long-term use in children with muscle weakness due to Myasthenia Gravis.
1Treatment groups
Experimental Treatment
Group I: Zilucoplan ArmExperimental Treatment1 Intervention
Study participants will receive Zilucoplan at a pre-defined dose based on their weight.
Zilucoplan is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Zilbrysq for:
- Generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive
🇪🇺 Approved in European Union as Zilbrysq for:
- Generalized myasthenia gravis in adults whose immune system produces antibodies against the acetylcholine receptor
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mg0015 50574Denton, TX
Mg0015 50168Chicago, IL
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Who Is Running the Clinical Trial?
UCB Biopharma SRLLead Sponsor