Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

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.

Official Title

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis

Keywords

Generalized Myasthenia Gravis, IMVT-1402, Acetylcholine receptor, Muscle-specific kinase, Autoantibody, Lipoprotein receptor-related protein 4, Autoimmune disease, Neonatal fragment crystallizable receptor (FcRn), Myasthenia Gravis, Autoimmune Diseases

Eligibility

You can join if…

Open to people ages 18-80

  • 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)

Additional inclusion criteria are defined in the protocol.

You CAN'T join if...

  • 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

Additional exclusion criteria are defined in the protocol.

Locations

  • Site Number - 1004 accepting new patients
    San Francisco California 94143 United States
  • Site Number - 1023 accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immunovant Sciences GmbH
ID
NCT07039916
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 231 study participants
Last Updated