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 Czechia 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-1402 →IMVT-1402 →PlaceboIMVT-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

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)

Change from Baseline in MG-ADL Score for Antibody-positive Participants — Baseline to Week 12

Trial sites (88)

Facility	City	Region	Status
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.

More Immunovant Sciences GmbH trials in Czechia

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease Recruiting

A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis Active, not recruiting

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) Enrolling by invitation

Other trials for the same condition

A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis Recruiting

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis Active, not recruiting

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG) Recruiting

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 Czechia