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IMVT-1402

Phase 3

Generalized Myasthenia Gravis | Small molecule | Neurology |Immunovant, Inc.|Last Updated: Aug 28, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment231

FDA Designations

No designations recorded

Clinical trial landscape

IMVT-1402 · 7 trials · 6 indications

Phase 3 1Phase 2 6
NCT07039916Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia GravisGeneralized Myasthenia Gravis
RECRUITING231 Analytics
PHASE3RECRUITING
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
Generalized Myasthenia GravisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in MG-ADL Score for Antibody-positive Participants
Baseline to Week 12
Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402
At Week 52
Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
Baseline and at Week 24

The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.

Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
Week 26
Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12
Baseline (Day 1) and Week 12

The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation.

Proportion of participants who maintain ACR20 response at Week 28
Week 28
Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26
Week 26

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1: IMVT-1402 Dose 1EXPERIMENTAL -
Group 2: IMVT-1402 Dose 2EXPERIMENTAL -
Placebo/ IMVT-1402PLACEBO_COMPARATOR -
Group AEXPERIMENTAL -
Group BNO_INTERVENTION -
Group CNO_INTERVENTION -
PlaceboPLACEBO_COMPARATOR -
IMVT-1402 Dose 1EXPERIMENTAL -
IMVT-1402 Dose 2EXPERIMENTAL -
Period 1: PlaceboPLACEBO_COMPARATORMatching placebo for 12 weeks in Period 1
IMVT-1402 Subcutaneous (SC) Once weekly (QW)EXPERIMENTAL* Period 1: IMVT-1402 Dose 1 SC QW for 12 weeks * Period 2: IMVT-1402 Dose 1 SC QW for 14 weeks * Period 3: IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks
Group 1 Period 1 and 2: IMVT-1402EXPERIMENTAL -
Group 2 Period 1 and 2: IMVT-1402EXPERIMENTAL -
Group 2 Period 1: IMVT-1402 and Period 2: PlaceboEXPERIMENTAL -
Group 3 Period 1 and 2: PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
IMVT-1402DRUG• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
PlaceboDRUG• Placebo SC QW for 12 weeks (Period 1)
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites88

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 th...

Countries:United StatesArgentinaCzechiaDenmarkGeorgiaGermanyGreeceHungaryItalyMexicoPolandRomaniaSerbiaSpainUnited KingdomAustraliaBulgariaLatviaSouth KoreaBrazilCanadaChileColombiaPeruIsraelJapanNetherlandsNew ZealandPuerto RicoBelgium
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Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT06980805lastUpdatePostDate: changed
LOWAug 28, 2026NCT06980805lastUpdatePostDate: changed
LOWAug 25, 2026NCT06727604lastUpdatePostDate: changed
LOWAug 25, 2026NCT07018323lastUpdatePostDate: changed
LOWAug 25, 2026NCT06727604lastUpdatePostDate: changed
LOWAug 25, 2026NCT07018323lastUpdatePostDate: changed
LOWAug 12, 2026NCT06979531lastUpdatePostDate: changed
LOWAug 12, 2026NCT07018323lastUpdatePostDate: changed
LOWAug 12, 2026NCT06979531lastUpdatePostDate: changed
LOWAug 12, 2026NCT07018323lastUpdatePostDate: changed
LOWAug 11, 2026NCT06727604lastUpdatePostDate: changed
LOWAug 11, 2026NCT06727604lastUpdatePostDate: changed
LOWJul 30, 2026NCT07039916lastUpdatePostDate: changed
LOWJul 30, 2026NCT07039916lastUpdatePostDate: changed
LOWJul 27, 2026NCT07018323lastUpdatePostDate: changed
LOWJul 27, 2026NCT07286006lastUpdatePostDate: changed
LOWJul 27, 2026NCT07018323lastUpdatePostDate: changed
LOWJul 27, 2026NCT07286006lastUpdatePostDate: changed
LOWJul 27, 2026NCT07018323lastUpdatePostDate: changed
LOWJul 27, 2026NCT07286006lastUpdatePostDate: changed

Frequently asked questions about IMVT-1402

What is IMVT-1402 used for?

IMVT-1402 is an investigational small molecule being developed for Primary Sjögren's Syndrome, Graves' Disease, Generalized Myasthenia Gravis, Rheumatoid Arthritis, and Subacute Cutaneous Lupus Erythematosus. It is currently in Phase 3 clinical development for these indications.

Who makes IMVT-1402?

IMVT-1402 is being developed by Immunovant, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IMVT. The company is conducting clinical trials to evaluate the drug's efficacy and safety in multiple autoimmune conditions.

What phase is IMVT-1402 in?

IMVT-1402 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Active trials are ongoing for Rheumatoid Arthritis, Primary Sjögren's Syndrome, and Graves' Disease, with additional studies planned.

What clinical trials is IMVT-1402 in?

IMVT-1402 is being studied in several Phase 2 trials, including NCT06754462 for Rheumatoid Arthritis, NCT06979531 for Primary Sjögren's Syndrome, and NCT07018323 for Graves' Disease. A long-term extension study, NCT07286006, is also enrolling patients with Graves' Disease.

Is IMVT-1402 the same as any other drug?

IMVT-1402 is a distinct investigational compound developed by Immunovant. No alternative names have been reported for this drug. It is being evaluated as a potential treatment for various autoimmune diseases, but it is not yet approved for any indication.