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

EU CTIS

Registry ID

CTIS2024-515979-35-00

Acronym

IMVT-1402-3101

Enrollment

Registered

2025-10-20

Start date

2025-11-13

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Generalized Myasthenia Gravis

Brief summary

Change from baseline in MG-ADL Score for Antibody-positive Participants

Detailed description

Change from baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants, Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1, Percentage of Antibody-Positive Participants with ≥50% Improvement in MG-ADL Score

Interventions

DRUGIMVT-1402

DRUGPlacebo is identical to IMP but with no active substance

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in MG-ADL Score for Antibody-positive Participants	—

Secondary

Measure	Time frame
Change from baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants, Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1, Percentage of Antibody-Positive Participants with ≥50% Improvement in MG-ADL Score	—

Countries

Czechia, Denmark, Germany, Greece, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026