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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Generalized Myasthenia Gravis

In brief

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.

Key facts

Study ID

NCT07039916

Run by

Immunovant Sciences GmbH

People needed

231

Starts

2025-05-27

Expected to finish

2028-12-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Site Number - 1041 — Mobile, Alabama, United States (enrolling)
• Site Number - 1017 — Phoenix, Arizona, United States (enrolling)
• Site Number - 1025 — Scottsdale, Arizona, United States (enrolling)
• Site Number - 1042 — Tucson, Arizona, United States (enrolling)
• Site Number - 1010 — Carlsbad, California, United States (enrolling)
• Site Number - 1028 — Irvine, California, United States (enrolling)
• Site Number - 1023 — Los Angeles, California, United States (enrolling)
• Site Number - 1029 — Rancho Mirage, California, United States (enrolling)
• Site Number - 1004 — San Francisco, California, United States (enrolling)
• Site Number - 1027 — Fort Collins, Colorado, United States (enrolling)
• Site Number - 1001 — New Haven, Connecticut, United States (enrolling)
• Site Number - 1024 — Washington D.C., District of Columbia, United States (enrolling)
• Site Number - 1006 — Clearwater, Florida, United States (enrolling)
• Site Number - 1037 — Ormond Beach, Florida, United States (enrolling)
• Site Number - 1002 — Port Charlotte, Florida, United States (enrolling)
• Site Number - 1050 — Rockledge, Florida, United States (enrolling)
• Site Number - 1007 — Tampa, Florida, United States (enrolling)
• Site Number - 1014 — Atlanta, Georgia, United States (enrolling)
• Site Number - 1043 — Augusta, Georgia, United States (enrolling)
• Site Number - 1054 — Schaumburg, Illinois, United States (enrolling)
• Site Number - 1022 — Lexington, Kentucky, United States (enrolling)
• Site Number - 1032 — Nicholasville, Kentucky, United States (enrolling)
• Site Number - 1046 — New Orleans, Louisiana, United States (enrolling)
• Site Number - 1049 — Foxborough, Massachusetts, United States (enrolling)
• Site Number - 1056 — Huntsville, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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