Zilucoplan for Severe gMG Exacerbations
ConditionGeneralized Myasthenia Gravis (gMG)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMiriam Freimer
About this trial
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. Participation in the study will last for approximately 18 weeks.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Zilucoplan®
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov