Trial NCT07039916
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
- Phase
- Phase 3
- Sponsor
- Immunovant Sciences GmbH
- Conditions
- Generalized Myasthenia Gravis
- Ages
- 18–80 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 thymomaPrior malignancy
Additional exclusion criteria are defined in the protocol.
Restrictions found (1)
- Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Site Number - 1049 · Foxborough, Norfolk County