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

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07039916

Enrollment

231

Registered

2025-06-26

Start date

2025-05-27

Completion date

2028-12-01

Last updated

2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Keywords

IMVT-1402, Generalized Myasthenia Gravis, Acetylcholine receptor, Muscle-specific kinase, Autoantibody, Lipoprotein receptor-related protein 4, Autoimmune disease, Neonatal fragment crystallizable receptor (FcRn), Imeroprubart

Brief 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.

Interventions

DRUGIMVT-1402

• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)

DRUGPlacebo

• Placebo SC QW for 12 weeks (Period 1)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The Sponsor will also be blinded.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants	Baseline to Week 12
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

Countries

Argentina, Czechia, Denmark, Georgia, Germany, Greece, Hungary, Italy, Mexico, Poland, Romania, Serbia, Spain, United Kingdom, United States

Contacts

CONTACTCentral Study Contact

clinicaltrials@immunovant.com18007970414

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026