NCT07039916 · Immunovant Sciences GmbH
Study to Access the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
What this study is about
This is a 26-week study to assess the effectiveness, safety and how well patients handle the treatment of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
View original scientific description
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.
Interventions
DRUG
IMVT-1402
• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
DRUG
IMVT-1402
* Dose 2 SC QW for 12 weeks (Period 1) * Dose 2 SC QW for 14 weeks (Period 2) * Dose 2 SC QW for 52 weeks (Period 3)
DRUG
Placebo
• Placebo SC QW for 12 weeks (Period 1)
DRUG
IMVT-1402
* Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)
Primary outcome measures
Change from Baseline in MG-ADL Score for Antibody-positive Participants
Time frame: Baseline to Week 12
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Huntsville, Alabama
- Mobile, Alabama
- Phoenix, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Carlsbad, California
- Irvine, California
- Los Angeles, California
- Rancho Mirage, California
- San Francisco, California
- Fort Collins, Colorado
- New Haven, Connecticut
And 33 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations