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IMVT-1402 for adults 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

Phase 3 Interventional Immunovant Sciences GmbH · NCT07039916

This trial will test whether IMVT-1402 helps adults with mild to severe generalized myasthenia gravis improve symptoms and daily function compared with placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment231 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorImmunovant Sciences GmbH Industry-sponsored
Locations81 sites (Mobile, Alabama and 80 other locations)
Trial IDNCT07039916 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study enrolls adults with generalized myasthenia gravis (MGFA class II–IVa) who have meaningful symptoms (MG-ADL ≥6) to compare IMVT-1402 with placebo. Participants will receive IMVT-1402 or placebo and be followed over a treatment and safety monitoring period to track symptom changes, tolerability, and adverse events. Key exclusion criteria include recent myasthenic crisis, thymectomy within the past 6 months, and active or untreated thymoma. The trial aims to show whether IMVT-1402 improves daily functioning while maintaining an acceptable safety profile.

Who should consider this trial

Good fit: Adults with generalized myasthenia gravis classified as MGFA class II–IVa who have an MG-ADL score of at least 6, can give informed consent, and meet other protocol criteria are the intended participants.

Not a fit: Patients who recently experienced a myasthenic crisis, had a thymectomy within 6 months, have active or untreated thymoma, or who do not meet the MGFA class or MG-ADL thresholds are unlikely to be eligible or to receive benefit from this study.

Why it matters

Potential benefit: If successful, IMVT-1402 could reduce symptoms and improve daily functioning for adults with generalized myasthenia gravis who meet the entry criteria.

How similar studies have performed: Other antibody-directed and FcRn-targeting approaches for gMG have shown benefit in prior trials, so the general strategy has supporting evidence, although IMVT-1402 itself is being specifically tested in this Phase 3 trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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:

* 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.

Where this trial is running

Mobile, Alabama and 80 other locations

+31 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Generalized Myasthenia GravisIMVT-1402Acetylcholine receptorMuscle-specific kinaseAutoantibodyLipoprotein receptor-related protein 4Autoimmune diseaseNeonatal fragment crystallizable receptor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.