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

Immunovant

Status and phase: Enrolling; Phase 3

Conditions: Generalized Myasthenia Gravis

Treatments: Drug: Placebo; Drug: IMVT-1402

Study type: Interventional

Funder types: Industry

Identifiers

NCT07039916

2024-515979-35-00 (EU Trial (CTIS) Number)

IMVT-1402-3101

Details and patient eligibility

About

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.

Enrollment: 231 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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231 participants in 3 patient groups, including a placebo group

Group 1: IMVT-1402 Dose 1

Experimental group

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402

Drug: IMVT-1402

Group 2: IMVT-1402 Dose 2

Experimental group

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402

Drug: IMVT-1402

Placebo/ IMVT-1402

Placebo Comparator group

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402

Drug: IMVT-1402

Drug: Placebo