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NCT07039916PHASE3Recruiting

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

Immunovant Sciences GmbH

Start Date

5/27/2025

Completion Date

12/1/2028

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 Criteria

Age Range: 18 years to 80 years

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.

Interventions

DRUG

IMVT-1402

DRUG

IMVT-1402

DRUG

Placebo

DRUG

IMVT-1402

Interested in This Trial?

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Conditions

Generalized Myasthenia Gravis

Locations

Site Number - 1056

Huntsville, Alabama 35801

United States

Site Number - 1041

Mobile, Alabama 36604

United States

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 - 1050

Rockledge, Florida 32955

United States

Site Number - 1007

Tampa, Florida 33612

United States

Site Number - 1014

Atlanta, Georgia 30329

United States

Site Number - 1043

Augusta, Georgia 30912

United States

Site Number - 1054

Schaumburg, Illinois 60173

United States

Site Number - 1022

Lexington, Kentucky 40536-0284

United States

Site Number - 1032

Nicholasville, Kentucky 40356

United States

Site Number - 1046

New Orleans, Louisiana 70121

United States

Site Number - 1049

Foxborough, Massachusetts 02035

United States

Site Number - 1026

Detroit, Michigan 48201

United States

Site Number - 1005

East Lansing, Michigan 48824

United States

Site Number - 1018

Omaha, Nebraska 68198

United States

Site Number - 1019

Totowa, New Jersey 07512

United States

Site Number - 1036

New York, New York 10021

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 - 1038

Cincinnati, Ohio 45221

United States

Site Number - 1045

Oklahoma City, Oklahoma 73104

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 - 1057

Houston, Texas 77054

United States

Site Number - 1048

Lubbock, Texas 79414

United States

Site Number - 1009

Charlottesville, Virginia 22903

United States

Site Number - 1040

Richmond, Virginia 23298

United States

Site Number - 1035

Greenfield, Wisconsin 53228

United States

Site Number - 5003

Caba, C1428AQK

Argentina

Site Number - 5002

Rosario, S2000

Argentina

Site Number - 3201

Brno, 60300

Czechia

Site Number - 3601

Copenhagen, 2177

Denmark

Site Number - 8002

Tbilisi, 0114

Georgia

Site Number - 8003

Tbilisi, 114

Georgia

Site Number - 8001

Tbilisi, 159

Georgia

Site Number - 6502

Bochum, 44791

Germany

Site Number - 6504

Goettigen, 37075

Germany

Site Number - 6505

Magdeburg, 39120

Germany

Site Number - 6503

Würzburg, 97070

Germany

Site Number - 3903

Athens, 11528

Greece

Site Number - 3902

Athens, 12462

Greece

Site Number - 3901

Pátrai, 26504

Greece

Site Number - 3904

Thessaloniki, 54642

Greece

Site Number - 7552

Budapest, 1085

Hungary

Site Number - 7553

Budapest, 1204

Hungary

Site Number - 7551

Kistarcsa, 2143

Hungary

Site Number - 6003

Bergamo, 24127

Italy

Site Number - 6002

Milan, 20133

Italy

Site Number - 6001

Naples, 80131

Italy

Site Number - 6004

Rome, 136

Italy

Site Number - 2602

Mexico City, 6700

Mexico

Site Number - 3005

Gdansk, 80-214

Poland

Site Number - 3001

Katowice, 40-689

Poland

Site Number - 3006

Krakow, 31-324

Poland

Site Number - 3002

Krakow, 31-503

Poland

Site Number - 3003

Krakow, 31-505

Poland

Site Number - 3004

Lublin, 20-701

Poland

Site Number - 3007

Warsaw, 01-684

Poland

Site Number - 7502

Constanța, 900348

Romania

Site Number - 7501

Târgu Mureş, 540136

Romania

Site Number - 9001

Belgrade, 11000

Serbia

Site Number - 9002

Niš, 18000

Serbia

Site Number - 7103

Barcelona, 8195

Spain

Site Number - 7101

Córdoba, 14011

Spain

Site Number - 7104

Madrid, 28034

Spain

Site Number - 7003

Birmingham, B15 2GW

United Kingdom

Site Number - 7002

Glasgow, G51 4TF

United Kingdom

Site Number - 7004

London, WC1N 3BG

United Kingdom