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Clinical Trials in the USA / NCT07039916
Recruiting Phase 3

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

NCT07039916 · tracked via the Priya Life Science USA tracker
Sponsor
Immunovant Sciences GmbH
Phase
Phase 3
Started
2025-05-27
Last updated
2026-07-30

Condition(s) studied

Generalized Myasthenia Gravis

Investigational drug(s) / intervention(s)

IMVT-1402IMVT-1402PlaceboIMVT-1402

IMVT-1402: • Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)

IMVT-1402: * Dose 2 SC QW for 12 weeks (Period 1) * Dose 2 SC QW for 14 weeks (Period 2) * Dose 2 SC QW for 52 weeks (Period 3)

Placebo: • Placebo SC QW for 12 weeks (Period 1)

IMVT-1402: * Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion 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 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (88)

FacilityCityRegionStatus
Site Number - 1056 Huntsville Alabama Recruiting
Site Number - 1041 Mobile Alabama Recruiting
Site Number - 1017 Phoenix Arizona Recruiting
Site Number - 1025 Scottsdale Arizona Recruiting
Site Number - 1042 Tucson Arizona Recruiting
Site Number - 1010 Carlsbad California Recruiting
Site Number - 1028 Irvine California Recruiting
Site Number - 1023 Los Angeles California Recruiting
Site Number - 1029 Rancho Mirage California Recruiting
Site Number - 1004 San Francisco California Recruiting
Site Number - 1027 Fort Collins Colorado Recruiting
Site Number - 1001 New Haven Connecticut Recruiting
Site Number - 1024 Washington D.C. District of Columbia Recruiting
Site Number - 1006 Clearwater Florida Recruiting
Site Number - 1037 Ormond Beach Florida Recruiting
Site Number - 1002 Port Charlotte Florida Recruiting
Site Number - 1050 Rockledge Florida Recruiting
Site Number - 1007 Tampa Florida Recruiting
Site Number - 1014 Atlanta Georgia Recruiting
Site Number - 1043 Augusta Georgia Recruiting
Site Number - 1054 Schaumburg Illinois Recruiting
Site Number - 1022 Lexington Kentucky Recruiting
Site Number - 1032 Nicholasville Kentucky Recruiting
Site Number - 1046 New Orleans Louisiana Recruiting
Site Number - 1049 Foxborough Massachusetts Recruiting
Site Number - 1026 Detroit Michigan Recruiting
Site Number - 1005 East Lansing Michigan Recruiting
Site Number - 1018 Omaha Nebraska Recruiting
Site Number - 1019 Totowa New Jersey Recruiting
Site Number - 1036 New York New York Recruiting
Site Number - 1034 New York New York Recruiting
Site Number - 1020 Chapel Hill North Carolina Recruiting
Site Number - 1013 Durham North Carolina Recruiting
Site Number - 1044 Raleigh North Carolina Recruiting
Site Number - 1038 Cincinnati Ohio Recruiting
Site Number - 1045 Oklahoma City Oklahoma Recruiting
Site Number - 1011 Yukon Oklahoma Recruiting
Site Number - 1031 Eugene Oregon Recruiting
Site Number - 1030 Charleston South Carolina Recruiting
Site Number - 1015 Charleston South Carolina Recruiting

+ 48 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07039916 on ClinicalTrials.gov ↗ ← All trials in the USA