IMVT-1402 for adults with mild to severe generalized myasthenia gravis.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Site Number - 1056
  Huntsville, Alabama, United States Recruiting
• Site Number - 1041
  Mobile, Alabama, United States Recruiting
• Site Number - 1017
  Phoenix, Arizona, United States Recruiting
• Site Number - 1025
  Scottsdale, Arizona, United States Recruiting
• Site Number - 1042
  Tucson, Arizona, United States Recruiting
• Site Number - 1010
  Carlsbad, California, United States Recruiting

+38 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Central Study Contact
• Email: clinicaltrials@immunovant.com
• Phone: 18007970414

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.