CClinicalTrials.gg
RecruitingNCT07039916Updated Jul 30, 2026

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

A Phase 3 interventional study of IMVT-1402 and IMVT-1402 in Generalized Myasthenia Gravis, sponsored by Immunovant Sciences GmbH. Recruiting at 88 sites in 15 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Immunovant Sciences GmbH · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
231
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • 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
03

In context

Myasthenia Gravis

324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.

This study's planned enrollment of 231 is above the median of 44 across 212 interventional studies indexed under Myasthenia Gravis.

Browse Myasthenia Gravis studies →

Lead sponsor

Immunovant Sciences GmbH is the lead sponsor of 19 studies on the registry; 5 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
231 participants (estimated)

Study arms

  • Experimental
    Group 1: IMVT-1402 Dose 1

    Drug: IMVT-1402

  • Experimental
    Group 2: IMVT-1402 Dose 2

    Drug: IMVT-1402

  • Placebo comparator
    Placebo/ IMVT-1402

    Drug: Placebo · Drug: IMVT-1402

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)

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline to Week 12

Secondary outcomes

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

    Time frame: Baseline to Week 12

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

    Time frame: Week 12

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

    Time frame: Baseline to Week 12

07

Study locations

88 of 88 sites recruiting
  • Site Number - 1056
    Huntsville, Alabama 35801, United States
    Recruiting
  • 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
    Recruiting
  • Site Number - 1028
    Irvine, California 92697, United States
    Recruiting
  • Site Number - 1023
    Los Angeles, California 90033, United States
    Recruiting
  • Site Number - 1029
    Rancho Mirage, California 92270, United States
    Recruiting
  • Site Number - 1004
    San Francisco, California 94143, United States
    Recruiting
  • Site Number - 1027
    Fort Collins, Colorado 80528, United States
    Recruiting
  • Site Number - 1001
    New Haven, Connecticut 06510, United States
    Recruiting
  • Site Number - 1024
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • Site Number - 1006
    Clearwater, Florida 33761, United States
    Recruiting
  • Site Number - 1037
    Ormond Beach, Florida 32174, United States
    Recruiting
  • Site Number - 1002
    Port Charlotte, Florida 33952, United States
    Recruiting
  • Site Number - 1050
    Rockledge, Florida 32955, United States
    Recruiting
  • Site Number - 1007
    Tampa, Florida 33612, United States
    Recruiting
  • Site Number - 1014
    Atlanta, Georgia 30329, United States
    Recruiting
  • Site Number - 1043
    Augusta, Georgia 30912, United States
    Recruiting
  • Site Number - 1054
    Schaumburg, Illinois 60173, United States
    Recruiting
  • Site Number - 1022
    Lexington, Kentucky 40536-0284, United States
    Recruiting
  • Site Number - 1032
    Nicholasville, Kentucky 40356, United States
    Recruiting
  • Site Number - 1046
    New Orleans, Louisiana 70121, United States
    Recruiting
  • Site Number - 1049
    Foxborough, Massachusetts 02035, United States
    Recruiting
  • Site Number - 1026
    Detroit, Michigan 48201, United States
    Recruiting
  • Site Number - 1005
    East Lansing, Michigan 48824, United States
    Recruiting
  • Site Number - 1018
    Omaha, Nebraska 68198, United States
    Recruiting
  • Site Number - 1019
    Totowa, New Jersey 07512, United States
    Recruiting
  • Site Number - 1036
    New York, New York 10021, United States
    Recruiting
  • Site Number - 1034
    New York, New York 10065, United States
    Recruiting
  • Site Number - 1020
    Chapel Hill, North Carolina 27599, United States
    Recruiting
  • Site Number - 1013
    Durham, North Carolina 27710, United States
    Recruiting
  • Site Number - 1044
    Raleigh, North Carolina 27607, United States
    Recruiting
  • Site Number - 1038
    Cincinnati, Ohio 45221, United States
    Recruiting
  • Site Number - 1045
    Oklahoma City, Oklahoma 73104, United States
    Recruiting
  • Site Number - 1011
    Yukon, Oklahoma 73099, United States
    Recruiting
  • Site Number - 1031
    Eugene, Oregon 97477, United States
    Recruiting
  • Site Number - 1030
    Charleston, South Carolina 29425, United States
    Recruiting
  • Site Number - 1015
    Charleston, South Carolina 29486, United States
    Recruiting
  • Site Number - 1021
    Memphis, Tennessee 38120, United States
    Recruiting
  • Site Number - 1003
    Dallas, Texas 75206, United States
    Recruiting
  • Site Number - 1047
    Denton, Texas 76208, United States
    Recruiting
  • Site Number - 1057
    Houston, Texas 77054, United States
    Recruiting
  • Site Number - 1048
    Lubbock, Texas 79414, United States
    Recruiting
  • Site Number - 1009
    Charlottesville, Virginia 22903, United States
    Recruiting
  • Site Number - 1040
    Richmond, Virginia 23298, United States
    Recruiting
  • Site Number - 1035
    Greenfield, Wisconsin 53228, United States
    Recruiting
  • Site Number - 5003
    Caba, C1428AQK, Argentina
    Recruiting
  • Site Number - 5002
    Rosario, S2000, Argentina
    Recruiting
  • Site Number - 3201
    Brno, 60300, Czechia
    Recruiting
  • Site Number - 3601
    Copenhagen, 2177, Denmark
    Recruiting
  • Site Number - 8002
    Tbilisi, 0114, Georgia
    Recruiting
  • Site Number - 8003
    Tbilisi, 114, Georgia
    Recruiting
  • Site Number - 8001
    Tbilisi, 159, Georgia
    Recruiting
  • Site Number - 6502
    Bochum, 44791, Germany
    Recruiting
  • Site Number - 6504
    Goettigen, 37075, Germany
    Recruiting
  • Site Number - 6505
    Magdeburg, 39120, Germany
    Recruiting
  • Site Number - 6503
    Würzburg, 97070, Germany
    Recruiting
  • Site Number - 3903
    Athens, 11528, Greece
    Recruiting
  • Site Number - 3902
    Athens, 12462, Greece
    Recruiting
  • Site Number - 3901
    Pátrai, 26504, Greece
    Recruiting
  • Site Number - 3904
    Thessaloniki, 54642, Greece
    Recruiting
  • Site Number - 7552
    Budapest, 1085, Hungary
    Recruiting
  • Site Number - 7553
    Budapest, 1204, Hungary
    Recruiting
  • Site Number - 7551
    Kistarcsa, 2143, Hungary
    Recruiting
  • Site Number - 6003
    Bergamo, 24127, Italy
    Recruiting
  • Site Number - 6002
    Milan, 20133, Italy
    Recruiting
  • Site Number - 6001
    Naples, 80131, Italy
    Recruiting
  • Site Number - 6004
    Rome, 136, Italy
    Recruiting
  • Site Number - 2602
    Mexico City, 6700, Mexico
    Recruiting
  • Site Number - 3005
    Gdansk, 80-214, Poland
    Recruiting
  • Site Number - 3001
    Katowice, 40-689, Poland
    Recruiting
  • Site Number - 3006
    Krakow, 31-324, Poland
    Recruiting
  • Site Number - 3002
    Krakow, 31-503, Poland
    Recruiting
  • Site Number - 3003
    Krakow, 31-505, Poland
    Recruiting
  • Site Number - 3004
    Lublin, 20-701, Poland
    Recruiting
  • Site Number - 3007
    Warsaw, 01-684, Poland
    Recruiting
  • Site Number - 7502
    Constanța, 900348, Romania
    Recruiting
  • Site Number - 7501
    Târgu Mureş, 540136, Romania
    Recruiting
  • Site Number - 9001
    Belgrade, 11000, Serbia
    Recruiting
  • Site Number - 9002
    Niš, 18000, Serbia
    Recruiting
  • Site Number - 7103
    Barcelona, 8195, Spain
    Recruiting
  • Site Number - 7101
    Córdoba, 14011, Spain
    Recruiting
  • Site Number - 7104
    Madrid, 28034, Spain
    Recruiting
  • Site Number - 7003
    Birmingham, B15 2GW, United Kingdom
    Recruiting
  • Site Number - 7002
    Glasgow, G51 4TF, United Kingdom
    Recruiting
  • Site Number - 7004
    London, WC1N 3BG, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07039916
Lead sponsor
Immunovant Sciences GmbH
Responsible party
Sponsor
First posted
Jun 26, 2025
Start date
May 27, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 30, 2026

Study contacts

Central Study Contact
Contact
clinicaltrials@immunovant.com
18007970414

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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