RECRUITING

Study to Access 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

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

Quick Facts

Study Start:2025-05-27
Study Completion:2027-12
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 75 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 I, II, III, or IV 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 - 1010
Carlsbad, California, 92011
United States
Site Number - 1006
Clearwater, Florida, 33761
United States
Site Number - 1011
Yukon, Oklahoma, 73099
United States
Site Number - 1003
Dallas, Texas, 75206
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 Date2027-12

Study Record Updates

Study Start Date2025-05-27
Study Completion Date2027-12

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