Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorImmunovant Sciences GmbH

About this trial

The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.

Eligibility criteria

Qualifiers

Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.

Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit

Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)

Disqualifiers

Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit.

Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study

Have any active or untreated malignant thymoma

Trial design

Treatments tested in this trial

  • IMVT-1402
  • IMVT-1402
  • Placebo
  • IMVT-1402

Treatment groups

231 Participants
are divided into 3 treatment groups

Sponsors and collaborators