A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDianthus Therapeutics

About this trial

The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).

Eligibility criteria

Qualifiers

Must have given written informed consent before any study-related activities are carried out

Weight range between 40-130 kg at Screening

Acetylcholine receptor antibody (AChR Ab) positive, and

Myasthenia Gravis Foundation of America (MGFA) Class II-IVa

Disqualifiers

History or presence of significant medical/surgical condition including any acute illness, mental illness, or major surgery considered to be clinically significant or that could have potential impact on safety/efficacy or study procedures

Known complement deficiency

Prior history (at any time) of N. meningitidis infection

Participants with known seropositivity or who test positive for an active viral infection with human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBV; except participants who are seropositive because of HBV vaccination) or hepatitis C virus (HCV) during Screening

Trial design

Treatments tested in this trial

  • Claseprubart
  • Placebo
  • Claseprubart
  • Placebo

Treatment groups

195 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators