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NCT Number: NCT07039916

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

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.

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Key information

Conditions

Generalized Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Number - 5003, Caba, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMVT-1402

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

Placebo

Drug
  • Placebo SC QW for 12 weeks (Period 1)

Primary outcomes

  1. Change from Baseline in MG-ADL Score for Antibody-positive Participants

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants

    Time frame: Baseline to Week 12

  2. Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1

    Time frame: Week 12

  3. Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score

    Time frame: Baseline to Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Central Study Contact

CONTACT

[email protected]

18007970414

Sponsors and collaborators

Lead sponsor

Immunovant Sciences GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 26, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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