Generalized Myasthenia GravisPhase 3NCT07039916
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
A Phase 3 study testing IMVT-1402 in people with Generalized Myasthenia Gravis, run by Immunovant Sciences GmbH at 88 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- IMVT-1402
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 88 sitesin 15 countries
- Study dates
- 27 May 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
88 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
88 sites in 15 countries
United States48 sites, 48 recruiting
- Recruiting
Site Number - 1014
Atlanta, Georgia, 30329
- Recruiting
Site Number - 1043
Augusta, Georgia, 30912
- Recruiting
Site Number - 1010
Carlsbad, California, 92011
- Recruiting
Site Number - 1020
Chapel Hill, North Carolina, 27599
- Recruiting
Site Number - 1030
Charleston, South Carolina, 29425
- Recruiting
Site Number - 1015
Charleston, South Carolina, 29486
- Recruiting
Site Number - 1009
Charlottesville, Virginia, 22903
- Recruiting
Site Number - 1038
Cincinnati, Ohio, 45221
- Recruiting
Site Number - 1006
Clearwater, Florida, 33761
- Recruiting
Site Number - 1003
Dallas, Texas, 75206
- Recruiting
Site Number - 1047
Denton, Texas, 76208
- Recruiting
Site Number - 1026
Detroit, Michigan, 48201
- Recruiting
Site Number - 1013
Durham, North Carolina, 27710
- Recruiting
Site Number - 1005
East Lansing, Michigan, 48824
- Recruiting
Site Number - 1031
Eugene, Oregon, 97477
- Recruiting
Site Number - 1027
Fort Collins, Colorado, 80528
- Recruiting
Site Number - 1049
Foxborough, Massachusetts, 02035
- Recruiting
Site Number - 1035
Greenfield, Wisconsin, 53228
- Recruiting
Site Number - 1057
Houston, Texas, 77054
- Recruiting
Site Number - 1056
Huntsville, Alabama, 35801
- Recruiting
Site Number - 1028
Irvine, California, 92697
- Recruiting
Site Number - 1022
Lexington, Kentucky, 40536-0284
- Recruiting
Site Number - 1023
Los Angeles, California, 90033
- Recruiting
Site Number - 1048
Lubbock, Texas, 79414
- Recruiting
Site Number - 1021
Memphis, Tennessee, 38120
- Recruiting
Site Number - 1041
Mobile, Alabama, 36604
- Recruiting
Site Number - 1001
New Haven, Connecticut, 06510
- Recruiting
Site Number - 1046
New Orleans, Louisiana, 70121
- Recruiting
Site Number - 1036
New York, New York, 10021
- Recruiting
Site Number - 1034
New York, New York, 10065
- Recruiting
Site Number - 1032
Nicholasville, Kentucky, 40356
- Recruiting
Site Number - 1045
Oklahoma City, Oklahoma, 73104
- Recruiting
Site Number - 1018
Omaha, Nebraska, 68198
- Recruiting
Site Number - 1037
Ormond Beach, Florida, 32174
- Recruiting
Site Number - 1017
Phoenix, Arizona, 85028
- Recruiting
Site Number - 1002
Port Charlotte, Florida, 33952
- Recruiting
Site Number - 1044
Raleigh, North Carolina, 27607
- Recruiting
Site Number - 1029
Rancho Mirage, California, 92270
- Recruiting
Site Number - 1040
Richmond, Virginia, 23298
- Recruiting
Site Number - 1050
Rockledge, Florida, 32955
- Recruiting
Site Number - 1004
San Francisco, California, 94143
- Recruiting
Site Number - 1054
Schaumburg, Illinois, 60173
- Recruiting
Site Number - 1025
Scottsdale, Arizona, 85251
- Recruiting
Site Number - 1007
Tampa, Florida, 33612
- Recruiting
Site Number - 1019
Totowa, New Jersey, 07512
- Recruiting
Site Number - 1042
Tucson, Arizona, 85718
- Recruiting
Site Number - 1024
Washington D.C., District of Columbia, 20010
- Recruiting
Site Number - 1011
Yukon, Oklahoma, 73099
Poland7 sites, 7 recruiting
- Recruiting
Site Number - 3005
Gdansk, 80-214
- Recruiting
Site Number - 3001
Katowice, 40-689
- Recruiting
Site Number - 3006
Krakow, 31-324
- Recruiting
Site Number - 3002
Krakow, 31-503
- Recruiting
Site Number - 3003
Krakow, 31-505
- Recruiting
Site Number - 3004
Lublin, 20-701
- Recruiting
Site Number - 3007
Warsaw, 01-684
Germany4 sites, 4 recruiting
- Recruiting
Site Number - 6502
Bochum, 44791
- Recruiting
Site Number - 6504
Goettigen, 37075
- Recruiting
Site Number - 6505
Magdeburg, 39120
- Recruiting
Site Number - 6503
Würzburg, 97070
Greece4 sites, 4 recruiting
- Recruiting
Site Number - 3903
Athens, 11528
- Recruiting
Site Number - 3902
Athens, 12462
- Recruiting
Site Number - 3901
Pátrai, 26504
- Recruiting
Site Number - 3904
Thessaloniki, 54642
Italy4 sites, 4 recruiting
- Recruiting
Site Number - 6003
Bergamo, 24127
- Recruiting
Site Number - 6002
Milan, 20133
- Recruiting
Site Number - 6001
Naples, 80131
- Recruiting
Site Number - 6004
Rome, 136
Georgia3 sites, 3 recruiting
- Recruiting
Site Number - 8002
Tbilisi, 0114
- Recruiting
Site Number - 8003
Tbilisi, 114
- Recruiting
Site Number - 8001
Tbilisi, 159
Hungary3 sites, 3 recruiting
- Recruiting
Site Number - 7552
Budapest, 1085
- Recruiting
Site Number - 7553
Budapest, 1204
- Recruiting
Site Number - 7551
Kistarcsa, 2143
Spain3 sites, 3 recruiting
- Recruiting
Site Number - 7103
Barcelona, 8195
- Recruiting
Site Number - 7101
Córdoba, 14011
- Recruiting
Site Number - 7104
Madrid, 28034
United Kingdom3 sites, 3 recruiting
- Recruiting
Site Number - 7003
Birmingham, B15 2GW
- Recruiting
Site Number - 7002
Glasgow, G51 4TF
- Recruiting
Site Number - 7004
London, WC1N 3BG
Argentina2 sites, 2 recruiting
- Recruiting
Site Number - 5003
Caba, C1428AQK
- Recruiting
Site Number - 5002
Rosario, S2000
Romania2 sites, 2 recruiting
- Recruiting
Site Number - 7502
Constanța, 900348
- Recruiting
Site Number - 7501
Târgu Mureş, 540136
Serbia2 sites, 2 recruiting
- Recruiting
Site Number - 9001
Belgrade, 11000
- Recruiting
Site Number - 9002
Niš, 18000
About this study
Official title: 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
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
- Being tested
- IMVT-1402, Placebo
- 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
- Medical subject headings
- Myasthenia Gravis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVT-1402Drug
- Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
IMVT-1402Drug
- 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)
PlaceboDrug
- Placebo SC QW for 12 weeks (Period 1)
IMVT-1402Drug
- Dose 1 SC QW for 14 weeks (Period 2)
- Dose 1 SC QW for 52 weeks (Period 3)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: IMVT-1402 Dose 1 | Experimental | Not described Receives: Drug: IMVT-1402 |
| Group 2: IMVT-1402 Dose 2 | Experimental | Not described Receives: Drug: IMVT-1402 |
| Placebo/ IMVT-1402 | Placebo comparator | Not described Receives: Drug: Placebo; Drug: IMVT-1402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in MG-ADL Score for Antibody-positive Participants
Measured: Baseline to Week 12
Secondary outcomes (3)
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants
Measured: Baseline to Week 12
Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1
Measured: Week 12
Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start27 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039916
- Sponsor's protocol ID
- IMVT-1402-3101
- Other IDs
- 2024-515979-35-00
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07039916
- Acronym / sponsor ID
- IMVT-1402-3101
- 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)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMVT-1402• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1) | Drug | Group 1: IMVT-1402 Dose 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) | Drug | Group 2: IMVT-1402 Dose 2 |
| Placebo• Placebo SC QW for 12 weeks (Period 1) | Drug | Placebo/ IMVT-1402 |
| IMVT-1402* Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3) | Drug | Group 1: IMVT-1402 Dose 1, Placebo/ IMVT-1402 |
Primary outcome
Change from Baseline in MG-ADL Score for Antibody-positive Participants
Time frame: Baseline to Week 12
3 secondary outcomes
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants
Time frame: Baseline to Week 12
Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1
Time frame: Week 12
Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
88 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IMVT-1402 in people with Generalized Myasthenia Gravis, run by Immunovant Sciences GmbH at 88 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, Poland, Germany, Greece, Italy and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Central Study Contact (18007970414, clinicaltrials@immunovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in MG-ADL Score for Antibody-positive Participants (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.