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

NCT07039916 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: IMVT-1402-31012024-515979-35-00
• Study Type: interventional
• Target: 231
• Locations: 13 countries
• Sites: 81

Brief 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.

Conditions

Generalized Myasthenia Gravis

Keywords

IMVT-1402; Generalized Myasthenia Gravis; Acetylcholine receptor; Muscle-specific kinase; Autoantibody; Lipoprotein receptor-related protein 4; Autoimmune disease; Neonatal fragment crystallizable receptor (FcRn); Imeroprubart

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in MG-ADL Score for Antibody-positive Participants

  Baseline to Week 12

Secondary Outcomes (3)

• Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants

  Baseline to Week 12

• Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1

  Week 12

• Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score

  Baseline to Week 12

Study Arms (3)

Group 1: IMVT-1402 Dose 1

EXPERIMENTAL

Drug: IMVT-1402

Group 2: IMVT-1402 Dose 2

EXPERIMENTAL

Drug: IMVT-1402

Placebo/ IMVT-1402

PLACEBO COMPARATOR

Drug: Placebo; Drug: IMVT-1402

Interventions

Placebo DRUG

• Placebo SC QW for 12 weeks (Period 1)

Placebo/ IMVT-1402

IMVT-1402 DRUG

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

Group 1: IMVT-1402 Dose 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (81)

Site Number - 1041

Mobile, Alabama, 36604, United States

RECRUITING

Site Number - 1017

Phoenix, Arizona, 85028, United States

RECRUITING

Site Number - 1025

Scottsdale, Arizona, 85251, United States

RECRUITING

Site Number - 1042

Tucson, Arizona, 85718, United States

RECRUITING

Site Number - 1010

Carlsbad, California, 92011, United States

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Site Number - 1028

Irvine, California, 92697, United States

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Site Number - 1023

Los Angeles, California, 90033, United States

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Site Number - 1029

Rancho Mirage, California, 92270, United States

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Site Number - 1004

San Francisco, California, 94143, United States

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Site Number - 1027

Fort Collins, Colorado, 80528, United States

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Site Number - 1001

New Haven, Connecticut, 06510, United States

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Site Number - 1024

Washington D.C., District of Columbia, 20010, United States

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Site Number - 1006

Clearwater, Florida, 33761, United States

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Site Number - 1037

Ormond Beach, Florida, 32174, United States

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Site Number - 1002

Port Charlotte, Florida, 33952, United States

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Site Number - 1050

Rockledge, Florida, 32955, United States

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Site Number - 1007

Tampa, Florida, 33612, United States

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Site Number - 1014

Atlanta, Georgia, 30329, United States

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Site Number - 1043

Augusta, Georgia, 30912, United States

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Site Number - 1022

Lexington, Kentucky, 40536-0284, United States

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Site Number - 1032

Nicholasville, Kentucky, 40356, United States

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Site Number - 1046

New Orleans, Louisiana, 70121, United States

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Site Number - 1049

Foxborough, Massachusetts, 02035, United States

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Site Number - 1026

Detroit, Michigan, 48201, United States

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Site Number - 1005

East Lansing, Michigan, 48824, United States

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Site Number - 1018

Omaha, Nebraska, 68198, United States

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Site Number - 1019

Totowa, New Jersey, 07512, United States

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Site Number - 1036

New York, New York, 10021, United States

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Site Number - 1034

New York, New York, 10065, United States

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Site Number - 1020

Chapel Hill, North Carolina, 27599, United States

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Site Number - 1013

Durham, North Carolina, 27710, United States

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Site Number - 1044

Raleigh, North Carolina, 27607, United States

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Site Number - 1038

Cincinnati, Ohio, 45221, United States

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Site Number - 1045

Oklahoma City, Oklahoma, 73104, United States

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Site Number - 1011

Yukon, Oklahoma, 73099, United States

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Site Number - 1031

Eugene, Oregon, 97477, United States

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Site Number - 1030

Charleston, South Carolina, 29425, United States

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Site Number - 1015

Charleston, South Carolina, 29486, United States

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Site Number - 1021

Memphis, Tennessee, 38120, United States

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Site Number - 1003

Dallas, Texas, 75206, United States

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Site Number - 1047

Denton, Texas, 76208, United States

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Site Number - 1048

Lubbock, Texas, 79414, United States

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Site Number - 1009

Charlottesville, Virginia, 22903, United States

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Site Number - 1040

Richmond, Virginia, 23298, United States

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Site Number - 1035

Greenfield, Wisconsin, 53228, United States

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Site Number - 3201

Brno, 60300, Czechia

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Site Number - 3601

Copenhagen, 2177, Denmark

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Site Number - 8002

Tbilisi, 0114, Georgia

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Site Number - 8003

Tbilisi, 114, Georgia

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Site Number - 8001

Tbilisi, 159, Georgia

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Site Number - 6502

Bochum, 44791, Germany

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Site Number - 6504

Goettigen, 37075, Germany

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Site Number - 6505

Magdeburg, 39120, Germany

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Site Number - 6503

Würzburg, 97070, Germany

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Site Number - 3903

Athens, 11528, Greece

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Site Number - 3902

Athens, 12462, Greece

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Site Number - 3901

Pátrai, 26504, Greece

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Site Number - 3904

Thessaloniki, 54642, Greece

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Site Number - 7552

Budapest, 1085, Hungary

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Site Number - 7553

Budapest, 1204, Hungary

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Site Number - 7551

Kistarcsa, 2143, Hungary

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Site Number - 6003

Bergamo, 24127, Italy

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Site Number - 6002

Milan, 20133, Italy

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Site Number - 6001

Naples, 80131, Italy

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Site Number - 6004

Rome, 136, Italy

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Site Number - 3005

Gdansk, 80-214, Poland

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Site Number - 3001

Katowice, 40-689, Poland

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Site Number - 3006

Krakow, 31-324, Poland

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Site Number - 3002

Krakow, 31-503, Poland

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Site Number - 3003

Krakow, 31-505, Poland

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Site Number - 3004

Lublin, 20-701, Poland

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Site Number - 3007

Warsaw, 01-684, Poland

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Site Number - 7502

Constanța, 900348, Romania

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Site Number - 7501

Târgu Mureş, 540136, Romania

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Site Number - 9001

Belgrade, 11000, Serbia

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Site Number - 9002

Niš, 18000, Serbia

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Site Number - 7103

Barcelona, 8195, Spain

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Site Number - 7101

Córdoba, 14011, Spain

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Site Number - 7104

Madrid, 28034, Spain

RECRUITING

Site Number - 7002

Glasgow, G51 4TF, United Kingdom

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Site Number - 7004

London, WC1N 3BG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Immune System Diseases

Central Study Contacts

Central Study Contact

CONTACT

18007970414; clinicaltrials@immunovant.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sponsor will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3); IT (4); GE (3); DK (1); DE (4); ES (3); GR (4); RO (2); SE (2); CZ (1); US (45); GB (2); PL (7)