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

Phase 3

Recruiting

• Conditions: Generalized Myasthenia Gravis
• Interventions: Drug: IMVT-1402; Drug: Placebo

• Registration Number: NCT07039916
• Lead Sponsor: Immunovant Sciences GmbH

Brief Summary

This is a 26-week study to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-27
• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 231

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 I, II, III, or IV 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: IMVT-1402 Dose 1	IMVT-1402	-
Group 2: IMVT-1402 Dose 2	IMVT-1402	-
Placebo/ IMVT-1402	Placebo	-
Placebo/ IMVT-1402	IMVT-1402	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in MG-ADL Score for Antibody-positive Participants	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1	Week 12
Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score	Baseline to Week 12
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants	Baseline to Week 12

Trial Locations

Locations (4)

Site Number - 1010; 🇺🇸 Carlsbad, California, United States

Site Number - 1006; 🇺🇸 Clearwater, Florida, United States

Site Number - 1011; 🇺🇸 Yukon, Oklahoma, United States

Site Number - 1003; 🇺🇸 Dallas, Texas, United States