NCT07039916 Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
| NCT ID | NCT07039916 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Immunovant Sciences GmbH |
| Condition | Generalized Myasthenia Gravis |
| Study Type | INTERVENTIONAL |
| Enrollment | 231 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 231 participants in total. It began in 2025-05-27 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07039916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Generalized Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07039916 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 231 participants.
Is NCT07039916 currently recruiting?
Yes, NCT07039916 is actively recruiting participants. Contact the research team at clinicaltrials@immunovant.com for enrollment information.
Where is the NCT07039916 trial being conducted?
This trial is being conducted at Huntsville, United States, Mobile, United States, Phoenix, United States, Scottsdale, United States and 11 additional locations.
Who is sponsoring the NCT07039916 clinical trial?
NCT07039916 is sponsored by Immunovant Sciences GmbH. The trial plans to enroll 231 participants.