RECRUITING

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

Description

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.

Conditions

Generalized Myasthenia Gravis
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Related Conditions:

Generalized Myasthenia Gravis

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Generalized Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Carlsbad

Site Number - 1010, Carlsbad, California, United States, 92011

Clearwater

Site Number - 1006, Clearwater, Florida, United States, 33761

Yukon

Site Number - 1011, Yukon, Oklahoma, United States, 73099

Dallas

Site Number - 1003, Dallas, Texas, United States, 75206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunovant Sciences GmbH,

Study Record Dates

2027-12