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