Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAlexion Pharmaceuticals, Inc.
About this trial
The primary purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adult participants with Acetylcholine receptor (AChR) + Generalized Myasthenia Gravis (gMG).
Eligibility criteria
Qualifiers
Confirmed generalized MG: Diagnosis ≥6 months before screening, anti-AChR antibody positive, and supportive diagnostic evidence (e.g., abnormal SFEMG/RNS or response to anticholinesterase therapy).
Disease severity: MGFA Class II-IV at screening.
Symptoms threshold: MG-ADL ≥6 at screening and on Day 1.
Meningococcal vaccination: Up to date within 3 years or vaccinated before first dose to mitigate risk with complement inhibition.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Ravulizumab
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov