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

RECRUITINGPhase 3Sponsored by Immunovant Sciences GmbH
Actively Recruiting
PhasePhase 3
SponsorImmunovant Sciences GmbH
Started2025-05-27
Est. completion2027-12
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations44 sites

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.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions2

CancerGeneralized Myasthenia Gravis

Locations44 sites

Site Number - 1041
Mobile, Alabama, 36604
Site Number - 1017
Phoenix, Arizona, 85028
Site Number - 1025
Scottsdale, Arizona, 85251
Site Number - 1042
Tucson, Arizona, 85718
Site Number - 1010
Carlsbad, California, 92011

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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