RECRUITING

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

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Conditions

Generalized Myasthenia GravisIMVT-1402Acetylcholine receptorMuscle-specific kinaseAutoantibodyLipoprotein receptor-related protein 4Autoimmune diseaseNeonatal fragment crystallizable receptor (FcRn)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-05-27
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07039916

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
  2. * Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit
  3. * Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)
  1. * Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit.
  2. * Have had a thymectomy performed \< 6 months prior to the Screening Visit or have a planned thymectomy during the study
  3. * Have any active or untreated malignant thymoma

Contacts and Locations

Study Contact

Central Study Contact
CONTACT
18007970414
clinicaltrials@immunovant.com

Study Locations (Sites)

Site Number - 1017
Phoenix, Arizona, 85028
United States
Site Number - 1025
Scottsdale, Arizona, 85251
United States
Site Number - 1042
Tucson, Arizona, 85718
United States
Site Number - 1010
Carlsbad, California, 92011
United States
Site Number - 1028
Irvine, California, 92697
United States
Site Number - 1023
Los Angeles, California, 90033
United States
Site Number - 1029
Rancho Mirage, California, 92270
United States
Site Number - 1004
San Francisco, California, 94143
United States
Site Number - 1027
Fort Collins, Colorado, 80528
United States
Site Number - 1001
New Haven, Connecticut, 06510
United States
Site Number - 1024
Washington D.C., District of Columbia, 20010
United States
Site Number - 1006
Clearwater, Florida, 33761
United States
Site Number - 1037
Ormond Beach, Florida, 32174
United States
Site Number - 1002
Port Charlotte, Florida, 33952
United States
Site Number - 1007
Tampa, Florida, 33612
United States
Site Number - 1014
Atlanta, Georgia, 30329
United States
Site Number - 1032
Nicholasville, Kentucky, 40356
United States
Site Number - 1005
East Lansing, Michigan, 48824
United States
Site Number - 1019
Totowa, New Jersey, 07512
United States
Site Number - 1034
New York, New York, 10065
United States
Site Number - 1020
Chapel Hill, North Carolina, 27599
United States
Site Number - 1013
Durham, North Carolina, 27710
United States
Site Number - 1044
Raleigh, North Carolina, 27607
United States
Site Number - 1011
Yukon, Oklahoma, 73099
United States
Site Number - 1031
Eugene, Oregon, 97477
United States
Site Number - 1030
Charleston, South Carolina, 29425
United States
Site Number - 1015
Charleston, South Carolina, 29486
United States
Site Number - 1021
Memphis, Tennessee, 38120
United States
Site Number - 1003
Dallas, Texas, 75206
United States
Site Number - 1047
Denton, Texas, 76208
United States
Site Number - 1048
Lubbock, Texas, 79414
United States
Site Number - 1009
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Immunovant Sciences GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-05-27
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Generalized Myasthenia Gravis