Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

This is a 26-week study 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, Muscle Weakness

Eligibility

You can join if…

Open to people ages 18-75

  • 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 I, II, III, or IV 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 - 1029 accepting new patients
    Rancho Mirage California 92270 United States

Details

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