RecruitingPhase 3NCT07039916

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

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


Sponsor

Immunovant Sciences GmbH

Enrollment

231 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IMVT-1402, a drug called IMVT-1402, and others for people with generalized myasthenia gravis. The study is currently recruiting participants at 84 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIMVT-1402

• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)

DRUGIMVT-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)

DRUGPlacebo

• Placebo SC QW for 12 weeks (Period 1)

DRUGIMVT-1402

* Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)


Locations(84)

Site Number - 1056

Huntsville, Alabama, United States

Site Number - 1041

Mobile, Alabama, United States

Site Number - 1017

Phoenix, Arizona, United States

Site Number - 1025

Scottsdale, Arizona, United States

Site Number - 1042

Tucson, Arizona, United States

Site Number - 1010

Carlsbad, California, United States

Site Number - 1028

Irvine, California, United States

Site Number - 1023

Los Angeles, California, United States

Site Number - 1029

Rancho Mirage, California, United States

Site Number - 1004

San Francisco, California, United States

Site Number - 1027

Fort Collins, Colorado, United States

Site Number - 1001

New Haven, Connecticut, United States

Site Number - 1024

Washington D.C., District of Columbia, United States

Site Number - 1006

Clearwater, Florida, United States

Site Number - 1037

Ormond Beach, Florida, United States

Site Number - 1002

Port Charlotte, Florida, United States

Site Number - 1050

Rockledge, Florida, United States

Site Number - 1007

Tampa, Florida, United States

Site Number - 1014

Atlanta, Georgia, United States

Site Number - 1043

Augusta, Georgia, United States

Site Number - 1054

Schaumburg, Illinois, United States

Site Number - 1022

Lexington, Kentucky, United States

Site Number - 1032

Nicholasville, Kentucky, United States

Site Number - 1046

New Orleans, Louisiana, United States

Site Number - 1049

Foxborough, Massachusetts, United States

Site Number - 1026

Detroit, Michigan, United States

Site Number - 1005

East Lansing, Michigan, United States

Site Number - 1018

Omaha, Nebraska, United States

Site Number - 1019

Totowa, New Jersey, United States

Site Number - 1036

New York, New York, United States

Site Number - 1034

New York, New York, United States

Site Number - 1020

Chapel Hill, North Carolina, United States

Site Number - 1013

Durham, North Carolina, United States

Site Number - 1044

Raleigh, North Carolina, United States

Site Number - 1038

Cincinnati, Ohio, United States

Site Number - 1045

Oklahoma City, Oklahoma, United States

Site Number - 1011

Yukon, Oklahoma, United States

Site Number - 1031

Eugene, Oregon, United States

Site Number - 1030

Charleston, South Carolina, United States

Site Number - 1015

Charleston, South Carolina, United States

Site Number - 1021

Memphis, Tennessee, United States

Site Number - 1003

Dallas, Texas, United States

Site Number - 1047

Denton, Texas, United States

Site Number - 1048

Lubbock, Texas, United States

Site Number - 1009

Charlottesville, Virginia, United States

Site Number - 1040

Richmond, Virginia, United States

Site Number - 1035

Greenfield, Wisconsin, United States

Site Number - 5002

Rosario, Argentina

Site Number - 3201

Brno, Czechia

Site Number - 3601

Copenhagen, Denmark

Site Number - 8002

Tbilisi, Georgia

Site Number - 8003

Tbilisi, Georgia

Site Number - 8001

Tbilisi, Georgia

Site Number - 6502

Bochum, Germany

Site Number - 6504

Goettigen, Germany

Site Number - 6505

Magdeburg, Germany

Site Number - 6503

Würzburg, Germany

Site Number - 3903

Athens, Greece

Site Number - 3902

Athens, Greece

Site Number - 3901

Pátrai, Greece

Site Number - 3904

Thessaloniki, Greece

Site Number - 7552

Budapest, Hungary

Site Number - 7553

Budapest, Hungary

Site Number - 7551

Kistarcsa, Hungary

Site Number - 6003

Bergamo, Italy

Site Number - 6002

Milan, Italy

Site Number - 6001

Naples, Italy

Site Number - 6004

Rome, Italy

Site Number - 3005

Gdansk, Poland

Site Number - 3001

Katowice, Poland

Site Number - 3006

Krakow, Poland

Site Number - 3002

Krakow, Poland

Site Number - 3003

Krakow, Poland

Site Number - 3004

Lublin, Poland

Site Number - 3007

Warsaw, Poland

Site Number - 7502

Constanța, Romania

Site Number - 7501

Târgu Mureş, Romania

Site Number - 9001

Belgrade, Serbia

Site Number - 9002

Niš, Serbia

Site Number - 7103

Barcelona, Spain

Site Number - 7101

Córdoba, Spain

Site Number - 7104

Madrid, Spain

Site Number - 7002

Glasgow, United Kingdom

Site Number - 7004

London, United Kingdom

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NCT07039916


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