MedPath

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: 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

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
GroupInterventionDescription
Group 1: IMVT-1402 Dose 1IMVT-1402-
Group 2: IMVT-1402 Dose 2IMVT-1402-
Placebo/ IMVT-1402Placebo-
Placebo/ IMVT-1402IMVT-1402-
Primary Outcome Measures
NameTimeMethod
Change from Baseline in MG-ADL Score for Antibody-positive ParticipantsBaseline to Week 12
Secondary Outcome Measures
NameTimeMethod
Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1Week 12
Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL ScoreBaseline to Week 12
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive ParticipantsBaseline 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

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.